Clinical and Behavioral Correlates of Achieving and Maintaining Glycemic Targets in an Underserved Population With Type 2 Diabetes A Self-Management Intervention for African Americans With Comorbid Diabetes and Hypertension: A Pilot Randomized Controlled Trial Rationale and design: telephone-delivered behavioral skills interventions for Blacks with type 2 diabetes Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial An intervention to overcome clinical inertia and improve diabetes mellitus control in a primary care setting: Improving Primary Care of African Americans with Diabetes (IPCAAD) 8. An endocrinologist-supported intervention aimed at providers improves diabetes management in a primary care site: improving primary care of African Americans with diabetes (IPCAAD) 7. Clinic-Integrated Behavioral Intervention for Families of Youth With Type 1 Diabetes: Randomized Clinical Trial Do the Effects of Psychological Treatments on Improving Glycemic Control in Type 1 Diabetes Persist Over Time? A Long-Term Follow-Up of a Randomized Controlled Trial Effectiveness of a community health worker intervention among African American and Latino adults with type 2 diabetes: a randomized controlled trial. Effect of case management on glycemic control and behavioral outcomes for chinese people with type 2 diabetes: A 2-year study. Culturally Tailored Intervention for Rural African Americans With Type 2 Diabetes Closing the gap: effect of diabetes case management on glycemic control among low-income ethnic minority populations: the California Medi-Cal type 2 diabetes study. The effect of a structured behavioral intervention on poorly controlled diabetes: a randomized controlled trial. Nurse Case Management To Improve Glycemic Control in Diabetic Patients in a Health Maintenance Organization A culturally competent intervention of education and care for black women with type 2 diabetes. Evaluating a problem-based empowerment program for African Americans with diabetes: results of a randomized controlled trial. Controlled Trial of Nursing Interventions to Improve Health Outcomes of Older African American Women With Type 2 Diabetes
OBJECTIVE —In an underserved Latino area , we established a disease-management program and proved its effectiveness . However , many patients still remained above target . This study was design ed to evaluate which factors are associated with reaching program goals . RESEARCH DESIGN AND METHODS —This was a r and omized , prospect i ve , observational study in which patients enrolled in our program were followed for 2 years with outcomes , measures , and question naires assessed at baseline and at 6 , 12 , and 24 months . RESULTS —Overall , A1C fell by 1 % . Adherence to medication was the strongest predictor of reaching the target A1C of < 8 % ; baseline A1C was also predictive . Knowledge scores increased in those who reached target , but the measures of self-efficacy and empowerment did not change for either group . CONCLUSIONS —Diabetes management is effective in a lower-income Latino population . However , adherence was suboptimal even when medications were provided on-site for free . Further research into barriers associated with medication adherence is needed Introduction The objective of this pilot 6-month r and omized controlled trial was to determine the effectiveness of an intensive , community-based , group intervention that focused on diet , physical activity , and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension . Methods Sixty-one participants were r and omized into an intervention or control group . The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter . The intervention featured culturally tailored nutrition education , behavioral skills training , and social support focused on changes to diet and physical activity . The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker . Outcome measures were assessed at baseline and 6 months . The primary outcome was achievement of a 5 % weight reduction at 6 months . A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c ( HbA1c ) . Results Groups did not differ in achievement of the weight-loss goal . Intervention participants  lost a mean of 2.8 kg ( P = .01 ) ; control participants did not lose a significant amount of weight . A greater proportion of intervention ( 50.0 % ) than control ( 21.4 % ) participants reduced HbA1c by 0.5 percentage points or more at 6 months ( P = .03 ) . Conclusion The intervention was more effective than usual care ( short-term diabetes education ) at improving glycemic control , but not weight , in low-income African Americans with comorbid diabetes and hypertension . A community-based 6-month group class with culturally tailored education , behavioral skills training , and peer support can lead to a clinical ly significant reduction in HbA1c Background African Americans with Type 2 diabetes ( T2DM ) have higher prevalence of diabetes , poorer metabolic control , and greater risk for complications and death compared to American Whites . Poor outcomes in African Americans with T2DM can be attributed to patient , provider , and health systems level factors . Provider and health system factors account for < 10 % of variance in major diabetes outcomes including hemoglobin A1c ( HbA1c ) , lipid control , and re source use . Key differences appear to be at the patient level . Of the patient level factors , consistent differences between African Americans and American Whites with T2DM have been found in diabetes knowledge , self-management skills , empowerment , and perceived control . A variety of interventions to improve diabetes self-management have been tested including : 1 ) knowledge interventions ; 2 ) lifestyle interventions ; 3 ) skills training interventions ; and 4 ) patient activation and empowerment interventions . Most of these interventions have been tested individually , but rarely have they been tested in combination , especially among African Americans who have the greatest burden of diabetes related complications . This study provides a unique opportunity to address this gap in the literature . Methods / Design We describe an ongoing four-year r and omized clinical trial , using a 2 × 2 factorial design , which will test the efficacy of separate and combined telephone-delivered , diabetes knowledge/information and motivation/behavioral skills training interventions in high risk African Americans with poorly controlled T2DM ( HbA1c ≥ 9 % ) . Two-hundred thirty-two ( 232 ) male and female African-American participants , 18 years of age or older and with an HbA1c ≥ 9 % , will be r and omized into one of four groups for 12-weeks of phone interventions : ( 1 ) an education group , ( 2 ) a motivation/skills group , ( 3 ) a combined group or ( 4 ) a usual care/general health education group . Participants will be followed for 12-months to ascertain the effect of the interventions on glycemic control . Our primary hypothesis is that among African Americans with poorly controlled T2DM , patients r and omized to the combined diabetes knowledge/information and motivation/behavioral skills training intervention will have significantly greater reduction in HbA1c at 12 months of follow-up compared to the usual care/general health education group . Discussion Results from this study will provide important insight into how best to deliver diabetes education and skills training in ethnic minorities and whether combined knowledge/information and motivation/behavioral skills training is superior to the usual method of delivering diabetes education for African Americans with poorly controlled T2DM.Trial registration National Institutes of Health Clinical Trials Registry ( Clinical Trials.gov identifier # NCT00929838 ) Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs . We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population . We also explored whether reductions in glycated hemoglobin ( HbA1c ) will be more marked in minority persons . Methods We conducted an open-label r and omized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5 % ( ≥58 mmol/mol ) . Participants were r and omized to : 1 ) a Chronic Disease Self-Management Program ( CDSMP ; n = 101 ) ; 2 ) a diabetes self-care software on a personal digital assistant ( PDA ; n = 81 ) ; 3 ) a combination of interventions ( CDSMP + PDA ; n = 99 ) ; or 4 ) usual care ( control ; n = 95 ) . Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice . The primary outcome was change in HbA1c from r and omization to 12 months . Data were analyzed using a multilevel statistical model . Results Average baseline HbA1c in the CDSMP , PDA , CDSMP + PDA , and control arms were 9.4 % , 9.3 % , 9.2 % , and 9.2 % , respectively . HbA1c reductions at 12 months for the groups averaged 1.1 % , 0.7 % , 1.1 % , and 0.7 % , respectively and did not differ significantly from baseline based on the model ( P = .771 ) . Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts ( P < .004 ) , no other significant differences were observed in participants ’ diabetes self-care activities . Exploratory sub- analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups . Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control , these interventions did not fare significantly better than usual care in achieving glycemic control . More research is needed to underst and how these interventions can be most effective in clinical practice . The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control . Trial registration Clinical trials.gov Identifier : NCT01221090 BACKGROUND Although clinical trials have shown that proper management of diabetes can improve outcomes , and treatment guidelines are widespread , glycated hemoglobin ( HbA1c ) levels in the United States are rising . Since process measures are improving , poor glycemic control may reflect the failure of health care providers to intensify diabetes therapy when indicated-- clinical inertia . We asked whether interventions aim ed at health care provider behavior could overcome this barrier and improve glycemic control . METHODS In a 3-year trial , 345 internal medicine residents were r and omized to be controls or to receive computerized reminders providing patient-specific recommendations at each visit and /or feedback on performance every 2 weeks . When glucose levels exceeded 150 mg/dL ( 8.33 mmol/L ) during visits of 4038 patients , health care provider behavior was characterized as did nothing , did anything ( any intensification of therapy ) , or did enough ( if intensification met recommendations ) . RESULTS At baseline , residents did anything for 35 % of visits and did enough for 21 % of visits when changes in therapy were indicated , and there were no differences among intervention groups . During the trial , intensification increased most during the first year and then declined . However , intensification increased more in the feedback alone and feedback plus reminders groups than for reminders alone and control groups ( P<.001 ) . After 3 years , health care provider behavior in the reminders alone and control groups returned to baseline , whereas improvement with feedback alone and feedback plus reminders groups was sustained : 52 % did anything , and 30 % did enough ( P<.001 for both vs the reminders alone and control groups ) . Multivariable analysis showed that feedback on performance contributed independently to intensification and that intensification contributed independently to fall in HbA1c ( P<.001 for both ) . CONCLUSIONS Feedback on performance given to medical resident primary care providers improved provider behavior and lowered HbA1c levels . Similar approaches may aid health care provider behavior and improve diabetes outcomes in other primary care setting OBJECTIVE Management of diabetes is frequently suboptimal in primary care setting s , where providers often fail to intensify therapy when glucose levels are high , a problem known as clinical inertia . We asked whether interventions targeting clinical inertia can improve outcomes . RESEARCH DESIGN AND METHODS A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center . We studied all patients ( 4,138 ) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were r and omized to be control subjects or to receive one of three interventions . Instead of consultative advice , the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient 's visit , individual face-to-face feedback on performance for 5 min every 2 weeks , or both . RESULTS Over an average patient follow-up of 15 months within the intervention site , improvements in and final HbA1c ( A1C ) with feedback + reminders ( deltaA1C 0.6 % , final A1C 7.46 % ) were significantly better than control ( deltaA1C 0.2 % , final A1C 7.84 % , P < 0.02 ) ; changes were smaller with feedback only and reminders only ( P = NS vs. control ) . Trends were similar but not significant with systolic blood pressure ( sBP ) and LDL cholesterol . Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP . Over a 2-year period , overall glycemic control improved in the intervention site but did not change in other primary care sites ( final A1C 7.5 vs. 8.2 % , P < 0.001 ) . CONCLUSIONS Feedback on performance aim ed at overcoming clinical inertia and given to internal medicine resident primary care providers improves glycemic control . Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care setting OBJECTIVE : To test the effect on diabetes management outcomes of a low-intensity , clinic-integrated behavioral intervention for families of youth with type 1 diabetes . METHODS : Families ( n = 390 ) obtaining care for type 1 diabetes participated in a 2-year r and omized clinical trial of a clinic-integrated behavioral intervention design ed to improve family diabetes management practice s. Measurement of hemoglobin A1c , the primary outcome , was obtained at each clinic visit and analyzed central ly . Blood glucose meter data were downloaded at each visit . Adherence was assessed by using a semistructured interview at baseline , mid- study , and follow-up . Analyses included 2- sample t tests at predefined time intervals and mixed-effect linear-quadratic models to assess for difference in change in outcomes across the study duration . RESULTS : A significant overall intervention effect on change in glycemic control from baseline was observed at the 24-month interval ( P = .03 ) . The mixed-effect model showed a significant intervention by age interaction ( P < .001 ) . Among participants aged 12 to 14 , a significant effect on glycemic control was observed ( P = .009 for change from baseline to 24-month interval ; P = .035 for mixed-effect model across study duration ) , but there was no effect among those aged 9 to 11 . There was no intervention effect on child or parent report of adherence ; however , associations of change in adherence with change in glycemic control were weak . CONCLUSIONS : This clinic-integrated behavioral intervention was effective in preventing the deterioration in glycemic control evident during adolescence , offering a potential model for integrating medical and behavioral sciences in clinical care Objectives In a r and omized controlled trial , adults with Type 1 diabetes and suboptimal glycemic control who received motivational enhancement therapy ( MET ) plus cognitive behavioral therapy ( CBT )  had a greater reduction in their 12-month hemoglobin A1c ( HbA1c ) than those who received usual care ( UC ) . We tested whether improvements in glycemic control persisted up to 4 years after r and omization . Methods In the original trial , participants were r and omized to UC ( n = 121 ) , 4 sessions of MET ( n = 117 ) , or 4 sessions of MET plus 8 sessions of CBT  ( n = 106 ) . Of the 344 patients who participated in the original trial , 260 ( 75.6 % ) consented to take part in this posttrial study . A linear mixed model was fitted to available measurements to assess whether intervention effects on HbA1c at 12 months were sustained at 2 , 3 , and 4 years . Results Estimated mean HbA1c level was lower for participants in the two intervention arms when compared with UC at 2 , 3 , and 4 years , but none of the differences were statistically significant . At 4 years , estimated mean HbA1c level  for MET plus CBT was 0.28 % ( 95 % confidence interval = −0.22 % to 0.77 % ) lower than that for UC , and estimated mean HbA1c level for MET was 0.17 % ( 95 % confidence interval = −0.33 % to 0.66 % ) lower than that for UC . Conclusions There was no evidence of benefit for patients r and omized to MET plus CBT at 2 , 3 , or 4 years . Larger studies are needed to estimate long-term treatment effects with greater precision . Current models of psychological treatments in diabetes may need to be intensified or include maintenance sessions to maintain improvements in glycemic control . Abbreviations RCT = r and omized controlled trial ; MET = motivational enhancement therapy ; CBT = cognitive behavioral therapy ; UC = usual OBJECTIVES We tested the effectiveness of a culturally tailored , behavioral theory-based community health worker intervention for improving glycemic control . METHODS We used a r and omized , 6-month delayed control group design among 164 African American and Latino adult participants recruited from 2 health systems in Detroit , Michigan . Our study was guided by the principles of community-based participatory research . Hemoglobin A1c ( HbA1c ) level was the primary outcome measure . Using an empowerment-based approach , community health workers provided participants with diabetes self-management education and regular home visits , and accompanied them to a clinic visit during the 6-month intervention period . RESULTS Participants in the intervention group had a mean HbA1c value of 8.6 % at baseline , which improved to a value of 7.8 % at 6 months , for an adjusted change of -0.8 percentage points ( P < .01 ) . There was no change in mean HbA1c among the control group ( 8.5 % ) . Intervention participants also had significantly greater improvements in self-reported diabetes underst and ing compared with the control group . CONCLUSIONS This study contributes to the growing evidence for the effectiveness of community health workers and their role in multidisciplinary teams engaged in culturally appropriate health care delivery OBJECTIVE To examine the effect of case management on glycemic control and behavioral outcomes in adults with Type 2 diabetes in China . METHODS Participants were r and omly assigned to a 1-year case management ( CM ) group ( n=60 ) or control group ( n=60 ) . Monthly case management visits included identifying individuals ' diabetes-related problems , setting goals , planning self-care , and evaluating progress . During a 1-year follow-up , all participants attended visits every 3 months without intervention . RESULTS In the CM vs. the control group , HbA1c was reduced at 6 months compared to baseline ( P=0.034 ) , with trends at 12 and 24 months , and empowerment ability improved ( P<0.05 ) . Also in the CM vs. controls , total self-care behaviors , the frequency of exercise , blood glucose testing , and foot care were higher ( P<0.001 ) at 12 months , and the percentage of individuals with HbA1c ≤7.0 % was higher ( P=0.035 ) at 24 months . CONCLUSION The case management intervention in China was effective at 6 months and , based on trends in HbA1c at 12 and 24 months and results for behavioral outcomes , the intervention shows promise and warrants more research . PRACTICE IMPLICATION S A case management approach can enhance behavior change and glycemic control in Chinese with diabetes Purpose The purpose of this pilot study was to evaluate a culturally tailored intervention for rural African Americans . Social Cognitive Theory provided the framework for the study . Methods Twenty-two participants were recruited and r and omly assigned to either Group or Individual diabetes self-management ( DSME ) . Group DSME included story-telling , h and s-on activities , and problem-solving exercises . Individual DSME sessions focused on goal - setting and problem-solving strategies . Sessions were offered in an accessible community center over a 10-week period . Results Outcomes included glycosylated hemoglobin ( A1C ) , self-care actions , self-efficacy level , goal attainment , and satisfaction with DSME . Participants in both Group and Individual DSME improved slightly over the 3-month period in self-care activities , A1C level , and goal attainment . Although differences were not statistically significant , trends indicate improved scores on dietary actions , foot care , goal attainment , and empowerment for those experiencing Group DSME . Conclusions The culturally tailored approach was well received by all participants . Improvements among those receiving Individual DSME may indicate that brief sessions using a culturally tailored approach could enhance self-care and glycemic control . Additional testing among more participants over a longer time period is recommended OBJECTIVE Disparities exist in the diabetes health status of ethnic minority and /or low-income population s relative to other groups . A primary objective of diabetes management is to improve glycemic control . The feasibility of implementing intensive diabetes case management in disparate population s remains largely untested . RESEARCH DESIGN AND METHODS Clinical sites in three southern California counties serving low-income , ethnic minority population s participated in our study . We r and omized 362 Medicaid ( called Medi-Cal in California ) recipients with type 2 diabetes for at least 1 year to intervention ( diabetes case management ) or control ( traditional primary care treatment ) groups . Fifty-five percent of participants were minorities . Participants with HbA(1c ) levels less than 7.5 % , serious diabetes-related complications , or other serious medical conditions were excluded . We assessed the effect of the intervention ( ongoing diabetes case management added to primary care ) on glycemic control using serial HbA(1c ) measurements over several years . RESULTS The mean duration of follow-up was 25.3 months . HbA(1c ) decreased substantially in both groups from an average of 9.54 - 7.66 % ( a reduction of 1.88 % ) in the intervention group and from an average of 9.66 - 8.53 % ( a reduction of 1.13 % ) in the control group . This improvement was sustained throughout the study . The reduction in HbA(1c ) was consistently greater in the intervention group at each time point ( P < 0.001 ) , ranging between 0.65 at 6 months and 0.87 at study end . CONCLUSIONS Diabetes case management , added to primary care , substantially improved glycemic control compared with the control group . Diabetes case management can help reduce disparities in diabetes health status among low-income ethnic population BACKGROUND Although maintaining nearly normal glycemia delays onset and slows progression of diabetes complications , many patients with diabetes and their physicians struggle to achieve glycemic targets . The best methods to support patients as they follow diabetes prescriptions and recommendations are unclear . METHODS To test the efficacy of a behavioral diabetes intervention in improving glycemia in long- duration , poorly controlled diabetes , we r and omized 222 adults with diabetes ( 49 % type 1 ) ( mean [ SD ] age , 53 [ 12 ] years ; mean [ SD ] disease duration 18 [ 12 ] years ; mean [ SD ] hemoglobin A(1c ) [ HbA(1c ) ] concentration , 9.0 % [ 1.1 % ] ) to attend ( 1 ) a 5-session manual-based , educator-led structured group intervention with cognitive behavioral strategies ( structured behavioral arm ) ; ( 2 ) an educator-led attention control group education program ( group attention control ) ; or ( 3 ) unlimited individual nurse and dietitian education sessions for 6 months ( individual control ) . Outcomes were baseline and 3- , 6- , and 12-month postintervention HbA(1c ) levels ( primary ) and frequency of diabetes self-care , 3-day pedometer readings , 24-hour diet recalls , average number of glucose checks , physical fitness , depression , coping style , self-efficacy , and quality of life ( secondary ) . RESULTS Linear mixed modeling found that all groups showed improved HbA(1c ) levels ( P < .001 ) . However , the structured behavioral arm showed greater improvements than the group and individual control arms ( 3-month HbA(1c ) concentration changes : -0.8 % vs -0.4 % and -0.4 % , respectively ( P = .04 for group × time interaction ) . Furthermore , participants with type 2 disease showed greater improvement than those with type 1 ( P = .04 for type of diabetes × time interaction ) . Quality of life , glucose monitoring , and frequency of diabetes self-care did not differ by intervention over time . CONCLUSIONS A structured , cognitive behavioral program is more effective than 2 control interventions in improving glycemia in adults with long- duration diabetes . Educators can successfully use modified psychological and behavioral strategies . TRIAL REGISTRATION clinical trials.gov Identifier : NCT000142922 The Diabetes Control and Complications Trial ( DCCT ) and the Kumamoto study [ 1 , 2 ] showed that near-normal glycemic control reduces the development and progression of microvascular and neuropathic complications by approximately 50 % in type 1 and type 2 diabetes mellitus . Additional analyses [ 3 - 5 ] indicate that therapy to achieve near normalization of blood glucose levels is cost-effective compared with other treatments . Thus , the American Diabetes Association has recommended that all persons with diabetes attempt to achieve near normalization of blood glucose levels [ 6 ] . This recommendation is not routinely followed in medical practice . In a 1989 national survey of physician practice behaviors in the United States , 64 % of physicians agreed that achieving target HbA1c values is very important but only 18 % reported that they ordered HbA1c tests every 2 to 3 months for patients with type 1 diabetes [ 7 ] . Although 98 % agreed that patient education improves glucose control , only 55 % reported that they routinely used a dietitian or a diabetes educator in patient care . Studies indicate that bringing clinical practice into line with scientific knowledge can be difficult . Methods used to achieve diabetes control in clinical trials are re source intensive . The American Diabetes Association currently recommends that patients with diabetes see their primary care physicians two to four times per year . Data from the National Health Interview Survey , a nationally representative survey [ 8 ] , indicate that most patients with diabetes are seen by nonspecialists and that 69 % of physician visits last less than 15 minutes . Algorithms for diabetes care exist but may be complex and difficult for physicians to follow , given patient load , diversity of patients seen , lack of information systems , and time constraints . Simple , low-cost methods of translating guidelines into clinical care are required . One solution may be to make greater use of personnel other than physicians . Nurse case management was an integral part of intensive therapy in the DCCT and has proven to be effective in reducing smoking and cholesterol levels after acute myocardial infa rct ion [ 3 , 9 ] . A nonr and omized study [ 10 ] of more than 700 patients with diabetes in a health maintenance organization suggests that nurse case management may be effective in improving metabolic control . Other studies [ 11 , 12 ] show a strong association between algorithm-directed nurse interventions and improved glycemic control . To our knowledge , no r and omized , controlled clinical trial of nurse case management in diabetes has yet been published . In a 12-month r and omized , controlled trial , we compared a nurse case management model of diabetes care with usual diabetes management in a primary care setting . Methods Patients Our study was approved by the institutional review board of the Prudential Center for Health Care Research , and all patients gave written informed consent . Participants were recruited from two of the largest clinics within the Jacksonville Health Care Group , which is the largest provider of primary care services for the Prudential HealthCare HMO plan of Jacksonville , Florida . The Jacksonville Health Care Group is a group of 43 primary care physicians who provide care in eight clinics to more than 75 000 Prudential HealthCare plan members . Potential study participants were identified through a data base used to support quality -improvement activities . Prudential HealthCare HMO members who had diabetes were included in the data base if they had visited a physician for diabetes ( International Classification of Diseases , 9th Revision , codes 250.0 to 250.9 ) , had had a hospital cl aim processed for diabetes , had been seen by the utilization management nurse , or had been referred to an ophthalmologist for a diabetic retinal examination . This data base is up date d regularly . A list with each member 's name , address , telephone number , medical record number , member identification number , age , sex , physician , and clinic was generated by merging the data from the data base with enrollment information . In addition , a list of members who may have had diabetes was created by using pharmacy data . Adult members with diabetes who were potential study participants each received a recruitment call and were invited to schedule an appointment with a research assistant to discuss participation in the study . We made a total of 14 calls at different times and on different days before coding a member as unavailable . After consent was given and the eligibility assessment was completed , baseline information was obtained and an HbA1c test was ordered if the result of one given within the previous 60 days was not available . Patients were ineligible for the study if they had a recent HbA1c value less than 7.0 % ; had uncontrolled hypertension ( blood pressure > 180/110 mm Hg ) ; had unstable angina ( class 4 ) ; had had a myocardial infa rct ion in the past 3 months ; had had two or more episodes of seizures ; had alcoholism or drug abuse documented in the chart ; had late-stage complications of diabetes or other chronic conditions , such as severe immunodeficiency or cirrhosis ; were pregnant or were planning to become pregnant in the next 12 months ; or were unable to perform self-management . Patients were r and omly assigned in blocks to either the nurse case management ( intervention ) group or the usual care group . R and omization was based on a 1:1 allocation ratio and a block size of three . Each block contained six patients , three in each study group . This r and omization scheme ensured that the desired allocation ratio-one intervention patient to one usual care patient-was maintained after sequential enrollment of every sixth patient . Outcome Measures Change in HbA1c value was the primary outcome measure . Decreased HbA1c values correlate directly with reduced risk for diabetes-related microvascular and neuropathic complications in type 1 and type 2 diabetes [ 1 , 3 ] . We also assessed health-related quality of life by using four generic questions developed by the Centers for Disease Control and Prevention for the Behavioral Risk Factor Surveillance System ( BRFSS ) [ 13 , 14 ] . These questions evaluate key conceptual domains of health-related quality of life : 1 ) patient-perceived general health status , 2 ) patient-perceived physical dysfunction during the previous 30 days , 3 ) patient-perceived mental dysfunction during the previous 30 days , and 4 ) patient-perceived functional incapacity during the previous 30 days for either mental or physical reasons . The BRFSS quality -of-life measures have been vali date d in a national sample of adults in the United States [ 15 ] . Patient-perceived health was found to be a good proxy indicator for chronic disease conditions . The other three domains further characterize general health functioning and quality of life [ 15 ] . In this analysis , we report findings related to the patient-perceived general health status domain . Intervention and Follow-up The nurse case manager was a registered nurse and a certified diabetes educator . She was trained to follow a set of detailed management algorithms under the direction of a board-certified family medicine physician and an endocrinologist who were responsible for all diabetes management decisions for patients in the intervention group but were not primary care providers for these patients . The algorithms were specific for type of diabetes and were developed by a multidisciplinary team on which endocrinology , family medicine , nursing , pharmacy , health services research , and epidemiology were represented . The algorithms progressively moved a patient toward improvement of glycemic control through adjustments in medication , meal planning , and reinforcement of exercise ( Figure 1 ) . Figure 1 . Algorithm for management of type 2 diabetes mellitus . Patients assigned to receive nurse case management met with the nurse for an initial assessment , were instructed about a blood glucose monitoring schedule , and returned for a follow-up visit 2 weeks later . The initial visit with the nurse averaged 45 minutes . At the 2-week follow-up visit , the nurse review ed the patient 's blood glucose log ; explained the algorithm step to which the patient had been assigned ; and used this information as the baseline for subsequent medication adjustments , meal planning , and exercise reinforcement . Patients receiving nurse case management  were also referred to a 5-week , 12-hour diabetes education program that included individual counseling by a dietitian , individual counseling by an exercise therapist , and group diabetes education classes . Subsequent in-person follow-up visits occurred quarterly . Patients in the nurse case management group  who were taking insulin  received weekly follow-up telephone calls . After the nurse review ed the blood glucose log and discussed glucose values with the patient , medication regimens were adjusted as needed and meal planning and exercise were reinforced . Patients treated with oral agents or diet and exercise  received follow-up telephone calls every 2 weeks . The nurse case manager met at least biweekly with the family medicine physician and the endocrinologist to review patient progress , medication adjustments , and other issues related to diabetes care . All medication adjustments or changes were communicated to the patients ' regular primary care physicians . Patients assigned to receive usual care were given blood glucose meters and strips , were encouraged to discuss enrollment in the diabetes education class with their physicians if they had not done so in the past year , and continued to receive diabetes care and follow-up from their primary care physicians . The 5-week diabetes education program is a st and ard , free-of-charge benefit for all HMO members with diabetes . All Jacksonville Health Care Group primary care physicians participate in an annual diabetes care seminar and undergo regular peer review of their adherence to published diabetes care st and ards . Tests to This article reports on the development and pilot feasibility testing of a culturally competent intervention of education and care for black women with type 2 diabetes mellitus ( T2DM ) . Using a one group , pretest posttest quasi-experimental design , the intervention was tested with a convenience sample of 25 community black women with T2DM . The conceptual basis , process , and content of the intervention as well as the feasibility and acceptability of study material s and methods are described . Significant improvements from baseline to 3 months were observed in measures of glycemic control , weight , body mass index , and diabetes-related emotional distress . The findings suggest that a culturally sensitive intervention of nurse practitioner diabetes care and education is beneficial for black women with T2DM , result ing in program attendance , kept appointments , improved glycemic control and weight , and decreased diabetes-related emotional distress OBJECTIVE The objective of this study was to evaluate the impact of a problem-based empowerment patient education program specifically tailored for urban African Americans with type 2 diabetes . RESEARCH DESIGN AND METHODS The study used a r and omized controlled trial ( RCT ) pretest/post-test design with repeated measures . Patients were r and omly assigned to either a six-week intervention group or a six-week wait-listed control group . After completing the six sessions , patients were invited to participate in one of two follow-up conditions ; attend a monthly support group or receive a monthly phone call from a nurse . Assessment measures included HbA1C , lipids , blood pressure , weight , self-management behavior and psychosocial adaptation . RESULTS Both control and intervention patients showed a broad array of small-to-modest positive changes during the six-week RCT . These gains were maintained or improved upon during the one-year follow-up period . For patients in the two follow-up conditions , a positive correlation was seen between the number of follow-up contacts and their one-year HbA1C values . CONCLUSIONS We believe that results of this study can be attributed to volunteer bias , study effects ( ie , providing study data on several occasions to patients and their physicians during the one-year study period ) , and impact of the interventions . However , the study design does not allow us to examine the relative impact of these three factors on the patient improvements seen over the one-year study period Background : Type 2 diabetes affects one in five African American women older than 60 years . These women face distinct challenges in managing diabetes self-care . Therefore , tailored self-care interventions for this population need to be developed and tested . Objectives : The effectiveness of a tailored , four-visit , in-home symptom-focused diabetes intervention with and without booster telephone calls was compared with an attentional control focused on skills training for weight management and diet . Methods : African American women ( n = 180 ; > 55 years old , Type 2 diabetes mellitus > 1 year , HbA1c > 7 % ) were r and omly assigned to the intervention or attentional control condition . Half the intervention participants were assigned to also receive a telephone-delivered booster intervention . Participants were evaluated at baseline and 3 , 6 , and 9 months . Results : Baseline HbA1 was 8.3 in the intervention group ( n = 60 ) , 8.29 in the intervention with booster group ( n = 55 ) , and 8.44 in the attentional control condition ( n = 59 ) . HbA1c declined significantly in the whole sample ( 0.57 % ) with no differences between study arms . Participants in the booster arm decreased HbA1c by 0.76 % . Symptom distress , perceived quality of life , impact of diabetes , and self-care activities also improved significantly for the whole sample with no significant differences between study arms . Discussion : Parsimonious interventions of four in-person visits yielded clinical ly significant decreases in HbA1c . Although the weight and diet program was intended as an attentional control , the positive effects suggest it met a need in this population . Because the contents of both the intervention and the attentional control were effective despite different approaches , a revised symptom-focused intervention that incorporates weight and diet skills training may offer even better results
Characteristics of successful interventions included using problem solving with the patient , culturally tailoring the intervention , and using a nurse educator .
OBJECTIVE The use of behavioral interventions has been shown to improve glycemic control , however , the effectiveness of different behavioral interventions in one of the most high risk population s , African Americans , remains unclear .
Our systematic review identified and examined findings of published behavioral interventions targeted at African Americans to improve glycemic control .
The goal of our study was to distinguish which interventions were effective and identify areas for future research .