Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes Self-care, quality of life and clinical outcomes of type 2 diabetes patients: an observational cross-sectional study HeLP-Diabetes: randomised controlled trial protocol The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial Rationale and design: telephone-delivered behavioral skills interventions for Blacks with type 2 diabetes Effects of diabetes self-management programs on time-to-hospitalization among patients with type 2 diabetes: a survival analysis model. Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program Patients' education, and its impact on care outcomes, resource consumption and working conditions: data from the International Diabetes Management Practices Study (IDMPS). Effect of educational intervention based on PRECEDE-PROCEED model combined with self-management theory on self-care behaviors in type 2 diabetic patients. A mobile diabetes management and educational system for type-2 diabetics in Saudi Arabia (SAED). Effectiveness of self-management promotion educational program among diabetic patients based on health belief model Impact on psychosocial outcomes of a nationally available weight management program tailored for individuals with type 2 diabetes: Results of a randomized controlled trial. Efficacy of a self-management education program for people with type 2 diabetes: results of a 12 month trial. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial Making sense of change: patients' views of diabetes and GP-led integrated diabetes care. Effectiveness of individual and group interventions for people with type 2 diabetes1 Systematic medical assessment, referral and treatment for diabetes care in China using lay family health promoters: protocol for the SMARTDiabetes cluster randomised controlled trial How does change occur following a theoretically based self-management intervention for type 2 diabetes A culturally targeted self-management program for African Americans with type 2 diabetes mellitus. Home-based diabetes symptom self-management education for Mexican Americans with type 2 diabetes. Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS) for Diabetes
Background The 2013 Global Burden of Disease Study demonstrated the increasing burden of diabetes and the challenge it poses to the health systems of all countries . The chronic and complex nature of diabetes requires active self-management by patients in addition to clinical management in order to achieve optimal glycaemic control and appropriate use of available clinical services . This study is an evaluation of a “ real world ” peer support program aim ed at improving the control and management of type 2 diabetes ( T2DM ) in Australia . Methods The trial used a r and omised cluster design with a peer support intervention and routine care control arms and 12-month follow up . Participants in both arms received a st and ardised session of self-management education at baseline . The intervention program comprised monthly community-based group meetings over 12 months led by trained peer supporters and active encouragement to use primary health care and other community re sources and supports related to diabetes .  Clinical , behavioural and other measures were collected at baseline , 6 and 12 months . The primary outcome was the predicted 5 year cardiovascular disease risk using the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) Risk Equation at 12 months . Secondary outcomes included clinical measures , quality of life , measures of support , psychosocial functioning and lifestyle measures . Results Eleven of 12 planned groups were successfully implemented in the intervention arm . Both the usual care and the intervention arms demonstrated a small reduction in 5 year UKPDS risk and the mean values for biochemical and anthropometric outcomes were close to target at 12 months . There were some small positive changes in self-management behaviours . Conclusions The positive changes in self-management behaviours among intervention participants were not sufficient to reduce cardiovascular risk , possibly because approximately half of the study participants already had quite well controlled T2DM at baseline . Future research needs to address how to enhance community based programs so that they reach and benefit those most in need of re sources and supports to improve metabolic control and associated clinical outcomes .Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) ACTRN12609000469213 . Registered 16 June 2009 Abstract Aims To describe self-care of T2DM patients and to evaluate outcomes associated with self-care in T2DM patients . Methods A multicentre cross-sectional study was conducted on a sample of 302 r and omly selected T2DM patients . Clinical and socio-demographic data were collected by medical records . The Summary of Diabetes Self-care Activities was used to measure  self-care about diet , blood testing , exercise and foot care .  The EQ-5D was used to measure perceived quality of life . Multiple regression models were used to evaluate the associations between self-care and body mass index ( BMI ) , glycated haemoglobin ( HbA1c ) , presence of diabetes complications and quality of life ( QoL ) . Results Self-care was lower about exercise ( median = 2.0 ) and foot care ( median = 3.5 ) than about diet ( median = 5.2 ) and blood testing ( median = 4.5 ) . HbA1c was associated with diet ( p = 0.025 ) , exercise ( p = 0.017 ) and blood testing ( p = 0.034 ) . BMI was associated with exercise ( p = 0.0071 ) . Diabetes complications were associated with exercise ( p = 0.031 ) and blood testing ( p < 0.009 ) . QoL was associated with exercise ( p < 0.0001 ) , blood testing ( p = 0.032 ) and foot care ( p = 0.013 ) . Conclusions Self-care influences both clinical outcomes and quality of life of T2DM patients . Although exercise is more frequently associated with positive outcomes , it is particularly poor in T2DM population . Blood testing and foot care should be performed to prevent complications and not only when a health problem is already occurred . Interventions aim ed to improve exercise are recommended . Further research is needed to explore barriers to exercise Background Type 2 Diabetes Mellitus ( T2DM ) is common , affecting nearly 400 million people worldwide . Achieving good health for people with T2DM requires active self-management ; however , uptake of self-management education is poor , and there is an urgent need to find better , more acceptable , cost-effective methods of providing self-management support . Web-based self-management support has many potential benefits for patients and health services . The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for people with T2DM . Methods This will be a multi-centre individually r and omised controlled trial in primary care , recruiting adults with T2DM who are registered with participating general practice s in Engl and . Participants will be r and omised to receive either an evidence -based , theoretically informed , web-based self-management programme for people with T2DM which addresses medical , emotional , and role management , called Healthy Living for People with type 2 Diabetes ( HeLP-Diabetes ) or a simple information website . The joint primary outcomes are glycated haemoglobin ( HbA1c ) and diabetes-related distress , measured by the Problem Areas In Diabetes ( PAID ) question naire . Secondary outcomes include cardiovascular risk factors , depression and anxiety , and self-efficacy for self-management of diabetes . Health economic data include health service use , costs due to the intervention , and EQ-5D for calculation of Quality Adjusted Life Years ( QALYS ) . Data will be collected at baseline , 3 months and 12 months , with the primary endpoint at 12 months . Practice nurses , blinded to patient allocation , collect clinical data ; patients complete online question naires for patient reported measures . A sample size of 350 recruited participants allows for attrition of up to 15 % and will provide 90 % power of detecting at a 5 % significance level a true average difference in the PAID score of 4.0 and 0.25 % change in HbA1c ( both small effect sizes ) . The analysis will follow a pre-specified analysis plan , based on comparing the groups as r and omised ( intention-to-treat ) . Discussion The findings of this trial are likely to be of interest to policy makers , clinicians , and commissioners , all of whom are actively seeking additional forms of self-management support for people with T2DM.Trial registration The Trial Registration number is IS RCT N02123133 ; date of registration 14.2.13 Background Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register Background Many community-based self-management programs have been developed for older adults with type-2 diabetes mellitus ( T2DM ) , bolstered by evidence from r and omized controlled trials ( RCTs ) that T2DM can be prevented and managed through lifestyle modifications . However , the evidence for their effectiveness is contradictory and weakened by reliance on single-group design s and /or small sample s. Additionally , older adults with multiple chronic conditions ( MCC ) are often excluded because of recruiting and retention challenges . This paper presents a protocol for a two-armed , multisite , pragmatic , mixed- methods RCT examining the effectiveness and implementation of the Aging , Community and Health Research Unit-Community Partnership Program ( ACHRU-CPP ) , a new 6-month interprofessional , nurse-led program to promote self-management in older adults ( aged 65 years or older ) with T2DM and MCC and support their caregivers ( including family and friends ) . Methods / design The study will enroll 160 participants in two Canadian provinces , Ontario and Alberta . Participants will be r and omly assigned to the control ( usual care ) or program study arm . The program will be delivered by registered nurses ( RNs ) and registered dietitians ( RDs ) from participating diabetes education centers ( Ontario ) or primary care networks ( Alberta ) and program coordinators from partnering community-based organizations . The 6-month program includes three in-home visits , monthly group sessions , monthly team meetings for providers , and nurse-led care coordination . The primary outcome is the change in physical functioning as measured by the Physical Component Summary ( PCS-12 ) score from the short form-12v2 health survey ( SF-12 ) . Secondary client outcomes include changes in mental functioning , depressive symptoms , anxiety , and self-efficacy . Caregiver outcomes include health-related quality of life and depressive symptoms . The study includes a comparison of health care service costs for the intervention and control groups , and a subgroup analysis to determine which clients benefit the most from the program . Descriptive and qualitative data will be collected to examine implementation of the program and effects on interprofessional/team collaboration . Discussion This study will provide evidence of the effectiveness of a community-based self-management program for a complex target population . By study ing both implementation and effectiveness , we hope to improve the uptake of the program within the existing community-based structures , and reduce the research -to- practice gap . Trial registration Clinical Trials.gov , Identifier : NCT02158741 . Registered on 3 June 2014 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 ) OBJECTIVE This study compared time-to-hospitalization among subjects enrolled in different diabetes self-management programs ( DSMP ) . We sought to determine whether the interventions delayed the occurrence of any acute event necessitating hospitalization . METHODS Electronic medical records ( EMR ) were obtained for 376 adults enrolled in a r and omized controlled trial ( RCT ) of Type 2 diabetes ( T2DM ) self-management programs . All study participants had uncontrolled diabetes and were r and omized into either : personal digital assistant ( PDA ) , Chronic Disease Self-Management Program ( CDSMP ) , combined PDA and CDSMP ( COM ) , or usual care ( UC ) groups . Subjects were followed for a maximum of two years . Time-to-hospitalization was measured as the interval between study enrollment and the occurrence of a diabetes-related hospitalization . RESULTS Subjects enrolled in the CDSMP-only arm had significantly prolonged time-to-hospitalization ( Hazard ratio : 0.10 ; p=0.002 ) when compared to subjects in the control arm . Subjects in the PDA-only and combined PDA and CDSMP arms showed no improvements in comparison to the control arm . CONCLUSION CDSMP can be effective in delaying time-to-hospitalization among patients with T2DM . PRACTICE IMPLICATION S Reducing unnecessary healthcare utilization , particularly inpatient hospitalization is a key strategy to improving the quality of health care and lowering associated health care costs . The CDSMP offers the potential to reduce time-to-hospitalization among T2DM patients Background India currently has more than 60 million people with Type 2 Diabetes Mellitus ( T2DM ) and this is predicted to increase by nearly two-thirds by 2030 . While management of those with T2DM is important , preventing or delaying the onset of the disease , especially in those individuals at ‘ high risk ’ of developing T2DM , is urgently needed , particularly in re source -constrained setting s. This paper describes the protocol for a cluster r and omised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala , India . Methods / design A total of 60 polling booths are r and omised to the intervention arm or control arm in rural Kerala , India . Data collection is conducted in two steps . Step 1 ( Home screening ) : Participants aged 30–60 years are administered a screening question naire . Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic ( Step 2 ) . At the mobile clinic , participants complete question naires , undergo physical measurements , and provide blood sample s for biochemical analysis . Participants identified with T2DM at Step 2 are excluded from further study participation . Participants in the control arm are provided with a health education booklet containing information on symptoms , complications , and risk factors of T2DM with the recommended levels for primary prevention . Participants in the intervention arm receive : ( 1 ) eleven peer-led small group sessions to motivate , guide and support in planning , initiation and maintenance of lifestyle changes ; ( 2 ) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors , prevention and management ; ( 3 ) a participant h and book containing information primarily on peer support and its role in assisting with lifestyle modification ; ( 4 ) a participant workbook to guide self-monitoring of lifestyle behaviours , goal setting and goal review ; ( 5 ) the health education booklet that is given to the control arm . Follow-up assessment s are conducted at 12 and 24 months . The primary outcome is incidence of T2DM . Secondary outcomes include behavioural , psychosocial , clinical , and biochemical measures . An economic evaluation is planned . Discussion Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other re source -constrained setting s . Trial registration Australia and New Zeal and Clinical Trials Registry : ACTRN12611000262909 AIM To evaluate the impact of diabetes education provided to patients with type 2 diabetes mellitus ( T2DM ) in non-controlled studies ( " real-world conditions " ) on quality of care , re source consumption and conditions of employment . METHODS This cross-sectional study and longitudinal follow-up describe the data ( demographic and socioeconomic profiles , clinical characteristics , treatment of hyperglycaemia and associated cardiovascular risk factors , re source consumption ) collected during the second phase ( 2006 ) of the International Diabetes Management Practice s Study ( IDMPS ) . Patients received diabetes education directly from the practice nurse , dietitian or educator , or were referred to ad hoc group-education programmes ; all programmes emphasized healthy lifestyle changes , self-care and active participation in disease control and treatment . Educated vs non-educated T2DM patients ( n=5692 in each group ) , paired by age , gender and diabetes duration , were r and omly recruited for the IDMPS by participating primary -care physicians from 27 countries in Eastern Europe , Asia , Latin America and Africa . Outcome measures included clinical ( body weight , height , waist circumference , blood pressure , foot evaluation ) , metabolic ( HbA(1c ) levels , blood lipid profile ) and biochemical control measures . Treatment goals were defined according to American Diabetes Association guidelines . RESULTS T2DM patients ' education significantly improved the percentage of patients achieving target values set by international guidelines . Educated patients increased their insulin use and self-care performance , had a lower rate of chronic complications and a modest increase in cost of care , and probably higher salaries and slightly better productivity . CONCLUSION Diabetes education is an efficient tool for improving care outcomes without having a major impact on healthcare costs AIMS Diabetes mellitus is a chronic and progressive disease which requires ongoing medical care as well as patient 's self-care skills to prevent acute complications . The purpose of this study is to determine the effect of the PRECEDE-PROCEED model combined with self-management theory on self-care behaviors in type 2 diabetic patients . METHODS In this semi-experimental study , 86 type 2 diabetic patients referred to the diabetes clinic of Ardabil were r and omly selected and divided into two groups ( n = 43 ) . Patients in group 1 received educations based on PRECEDE-PROCEED model combined with self-management theory while patients in group 2 received only educations based on PRECEDE-PROCEED model . The self-made question naire was used to measure demographic information and PRECEDE-PROCEED model variables at baseline and one month after the intervention . RESULTS The mean scores of knowledge , attitude , self-efficacy ( p = 0.001 ) , self-care ( p = 0.001 ) , enabling factors , and reinforcing factors had significant differences in both groups before and after the intervention ( p < 0.05 ) . In addition , one month after the intervention , the mean scores of attitude , self-efficacy , self-care , and reinforcing factors were significantly higher in group 1 compared to group 2 . CONCLUSION The results indicate the effectiveness of an educational intervention based on PRECEDE-PROCEED model combined with self-management theory to improve self-care behaviors in patients with type 2 diabetes BACKGROUND Diabetes is a chronic disease , with high prevalence across many nations , which is characterized by elevated level of blood glucose and risk of acute and chronic complication . The Kingdom of Saudi Arabia ( KSA ) has one of the highest levels of diabetes prevalence globally . It is well-known that the treatment of diabetes is complex process and requires both lifestyle change and clear pharmacologic treatment plan . To avoid the complication from diabetes , the effective behavioural change and extensive education and self-management is one of the key approaches to alleviate such complications . However , this process is lengthy and expensive . The recent studies on the user of smart phone technologies for diabetes self-management have proven to be an effective tool in controlling hemoglobin ( HbA1c ) levels especially in type-2 diabetic ( T2D ) patients . However , to date no reported study addressed the effectiveness of this approach in the in Saudi patients . This study investigates the impact of using mobile health technologies for the self-management of diabetes in Saudi Arabia . METHODS In this study , an intelligent mobile diabetes management system ( SAED ) , tailored for T2D patients in KSA was developed . A pilot study of the SAED system was conducted in Saudi Arabia with 20 diabetic patients for 6 months duration . The patients were r and omly categorized into a control group who did not use the SAED system and an intervention group whom used the SAED system for their diabetes management during this period . At the end of the follow-up period , the HbA1c levels in the patients in both groups were measure together with a diabetes knowledge test was also conducted to test the diabetes awareness of the patients . RESULTS The results of SAED pilot study showed that the patients in the intervention group were able to significantly decrease their HbA1c levels compared to the control group . The SAED system also enhanced the diabetes awareness amongst the patients in the intervention group during the trial period . These outcomes confirm the global studies on the effectiveness of smart phone technologies in diabetes management . The significance of the study is that this was one of the first such studies conducted on Saudi patients and of their acceptance for such technology in their diabetes self-management treatment plans . CONCLUSIONS The pilot study of the SAED system showed that a mobile health technology can significantly improve the HbA1C levels among Saudi diabetic and improve their disease management plans . The SAED system can also be an effective and low-cost solution in improving the quality of life of diabetic patients in the Kingdom considering the high level of prevalence and the increasing economic burden of this disease Introduction : Diabetes is a chronic disease ; it can cause serious complications . Diabetes self-management is essential for prevention of disease complications . This study was conducted to evaluate self-management promotion educational program intervention efficiency among diabetic patients in Iran and health belief model ( HBM ) was applied as a theoretical framework . Material s and Methods : Overall , 120 Type 2 diabetic patients referred to rural health centers in Gachsaran , Iran participated in this study as r and omly divided into intervention and control group . This was a longitudinal r and omized pre- and post-test series control group design panel study to implement a behavior modification based intervention to promotion self-management among diabetic patients . Cross-tabulation and t-test by using SPSS statistical package , version 16 was used for the statistical analysis . Results : Mean age was 55.07 years ( SD = 9.94 , range : 30 - 70 ) . Our result shows significant improvements in average response for susceptibility , severity , benefit and self-management among intervention group . Additionally , after intervention , average response of the barrier to self-management was decreased among intervention group . Conclusion : Our result showed education program based on HBM was improve of self-management and seems implementing these programs can be effective in the and prevention of diabetes complications AIMS Type 2 diabetes mellitus ( T2DM ) can substantially decrease quality of life ( QOL ) . This study examined the effects on QOL-relevant psychosocial measures of a widely available commercial weight loss program enhanced for individuals with T2DM . METHODS A year-long multi-site r and omized clinical trial compared the Weight Watchers ( WW ) approach , supplemented with phone and email counseling with a certified diabetes educator ( CDE ) , to brief st and ard diabetes nutrition counseling and education ( St and ard Care ; SC ) . Participants were 400 women and 163 men ( N=279 WW ; 284 SC ) with T2DM [ mean ( ±SD ) HbA1c 8.32±1 % ; BMI = 37.1±5.7kg/m2 ; age=55.1 ± 9.1years ] . Psychosocial outcomes were assessed at baseline , month 6 , and month 12 using a diabetes specific psychosocial measure ( Diabetes Distress Scale [ DDS ] ) , Impact of Weight on Quality of Life-Lite scale ( IWQOL ) , a generic QOL measure ( SF-36 ) , and a depression screen ( PHQ-9 ) . RESULTS WW participants showed significantly greater improvements than did SC participants on all DDS subscales and total score and on IWQOL total score and physical function , sex life and work domains ( all ps<.05 ) . There was no significant treatment effect on SF-36 scores or PHQ-9 . CONCLUSIONS WW enhanced for individuals with T2DM was superior to SC in improving psychosocial outcomes most specific to T2DM and obesity . Available commercial WL programs , combined with scalable complementary program-specific diabetes counseling , may have benefits that extend to diabetes-related distress and weight-relevant QOL AIM Patient education that enhances one 's self-management ability is of utmost importance for improving patient outcomes in chronic diseases . We developed a 12 month self-management education program for type 2 diabetes , based on a previous 6 month program , and examined its efficacy . METHODS A r and omized controlled trial was carried out on out patients with type 2 diabetes from two hospitals who met the criteria and gave consent to participate . They were r and omly divided into an intervention group that followed the program and a control group that followed usual clinical practise . The intervention group received < 30 min of monthly interviews based on the program 's textbook and biweekly telephone calls from a nurse educator throughout the 12 months . RESULTS Of the 50 participants in the intervention group and the 25 participants in the control group , 42 and 23 , respectively , completed the program ( a completion rate of 84.0 % ) . The body weight , HbA1c , self-efficacy , dietary and exercise stages , quality of life , diastolic blood pressure , and total cholesterol level were significant by two-way repeated- measures anova . As for changes over time within the groups , only the intervention group showed significant differences by Friedman 's test . The complication prevention behaviors showed a high implementation rate in the intervention group . The overall evaluation of this program by the participants was very high and , therefore , they highly recognized the need for this type of program . CONCLUSIONS Self-management education works successfully in relation to patients ' behavior modification skills , degree of goal attainment , and self-efficacy , consequently improving their health outcomes Background US Latinos have greater prevalence of type 2 diabetes ( diabetes ) , uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites . They also have lower literacy levels and are more likely to live in poverty . Interventions are needed to improve diabetes control among low-income Latinos . Methods and design This r and omized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention ( Latinos en Control ) on glycemic control among low-income Latinos with diabetes  , compared to usual care ( control ) .  Participants were recruited from five community health centers ( CHCs ) in Massachusetts . The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions . Assessment s occurred at baseline , and at 4 and 12 months . The primary outcome was glycosylated hemoglobin ( HbA1c ) . Secondary outcomes were self-management behaviors , weight , lipids and blood pressure . Additional outcomes included diabetes knowledge , self-efficacy , depression and quality of life . The study was design ed for recruitment of 250 participants ( estimated 20 % dropout rate ) to provide 90 % power for detecting a 7 % or greater change in HbA1c between the intervention and control groups . This is a difference in change of HbA1c of 0.5 to 0.6 % . Discussion Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population . Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities . This article describes the design and methods of a theory driven intervention aim ed at addressing this need . Trial registration http://www . clinical trials.gov # Background Gestational diabetes mellitus ( GDM ) is defined as glucose intolerance with its onset or first recognition during pregnancy . Post-GDM women have a life-time risk exceeding 70 % of developing type 2 diabetes mellitus ( T2DM ) . Lifestyle modifications reduce the incidence of T2DM by up to 58 % for high-risk individuals . Methods / Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program ( MAGDA-DPP ) is a r and omized controlled trial aim ing to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women . This trial has an intervention group participating in a diabetes prevention program ( DPP ) , and a control group receiving usual care from their general practitioners during the same time period . The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals , and two follow-up telephone calls .  A total of 574 women will be recruited , with 287 in each arm . The women will undergo blood tests , anthropometric measurements , and self-reported health status , diet , physical activity , quality of life , depression , risk perception and healthcare service usage , at baseline and 12 months . At completion , primary outcome ( changes in diabetes risk ) and secondary outcome ( changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors ) will be assessed in both groups . Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women . The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population .Trial registration Australian New Zeal and Clinical Trials Registry ANZCTRN BACKGROUND Health system reform is directed towards better management of diabetes . However , change can be difficult , and patients ' perspectives are a key aspect of implementing change . OBJECTIVE This study investigated patients ' perceptions and experiences  of  type 2 diabetes ( T2DM )  , self-care and engagement with GP-led integrated diabetes care . DESIGN Qualitative interviews were conducted with purposively selected patients with T2DM following their initial medical appointment in the new model of care .  Normalization process theory was used to orientate the thematic analysis , to explain the work of implementing change . SETTING Two specialist GP-based complex diabetes services in primary care in Brisbane , Australia . PARTICIPANTS Intervention group patients ( n = 30 ) in a r and omized controlled trial to evaluate a model of GP-led integrated care for complex T2DM . MAIN OUTCOME MEASURES Participants ' experiences and perceptions of diabetes management and a GP-led model  of care . RESULTS Three themes were identified : sensibility of change , ' diabetic life ' and diabetes care alliance . The imperative of change made sense , but some participants experienced dissonance between this rational view and their lived reality . Diabetes invaded life , revealing incongruities between participants ' values and living with diabetes . They appreciated a flexible and personalized approach to care . DISCUSSION Participants responded to advice in ways that seemed rational within the complexities of their life context . Their diabetes partnerships with health professionals coupled providers ' biomedical expertise with patients ' context ual expertise . CONCLUSIONS Learning to manage relationships with various health professionals adds to patients ' diabetes-related work . Providers need to adopt a flexible , interactive approach and foster trust , to enable better diabetes care OBJECTIVE : to compare the effectiveness of two educational interventions used by a healthcare provider in the monitoring of individuals with type 2 diabetes mellitus ( T2DM ) , regarding knowledge of the disease , impact on quality of life and adoption of self-care actions . METHODS : comparative , longitudinal , prospect i ve study performed with 150 subjects with type 2 diabetes , analyzed according to the type of participation in the program ( individual and /or group ) . Participants of the individual intervention ( II ) received nursing consultations every six months and those of the group intervention ( GI ) took part in weekly meetings for three months . Data were collected through four question naires : Identification question naire , Problem Areas in Diabetes Question naire ( PAID ) , Summary of Diabetes Self-Care Activities Question naire ( SDSCA ) and the Diabetes Knowledge Scale ( DKN-A ) . Data were analyzed using the Friedman and Mann Whitney tests , considering a statistical significance of p ≤ 0.05 . RESULTS : there was an increase in knowledge about the disease in the II ( p<0.003 ) and GI ( p<0.007 ) , with reduction of the impact on the quality of life in the II ( p<0.007 ) and improvement in self-care actions in the GI ( p<0.001 ) . CONCLUSION : in both intervention models improvements were observed in the indicators , over the six month monitoring period Background Type 2 diabetes ( T2DM ) affects 113.9 million people in China , the largest number of any country in the world ( JAMA 310:948–59 , 2013 ) . T2DM prevalence has risen dramatically from around 1 % in the 1980s to now over 10 % and is expected to continue rising . Despite the growing disease burden , few people with T2DM are achieving adequate management targets to prevent complications . Health system infrastructure in China is struggling to meet these gaps in care , and innovative , cost-effective and affordable solutions are needed . One promising strategy that may be particularly relevant to the Chinese context is improving support for lay family members to care for their relatives with T2DM . Methods We hypothesise that an interactive mobile health management system can support lay family health promoters ( FHP ) and healthcare staff to improve clinical outcomes for family members with T2DM through medical assessment , regular monitoring , lifestyle advice and the prescribing of guidelines recommended medications . This intervention will be implemented as a cluster r and omised controlled trial involving 80 communities ( 40 communities in Beijing and 40 rural villages in Hebei province ) and 2000 people with T2DM . Outcome analyses will be conducted blinded to intervention allocation . The primary outcome is the proportion of patients achieving ≥2 “ ABC ” goals ( HbA1c < 7.0 % , blood pressure ( BP ) < 140/80 mmHg and LDL cholesterol < 100 mg/dl or 2.6 mmol/L ) at the end of follow-up ( Diabetes Care 36(Supplement 1):S11-S66 , 2013 ) . Secondary outcomes include the proportion of patients achieving individual ABC targets ; mean changes in HbA1c , BP , LDL , renal function ( serum creatinine and urinary albumin ) , body mass index , quality of life ( QOL , EQ-5D ) , and healthcare utilisation from baseline ; and cost-effectiveness/utility of intervention . Trial outcomes will be accompanied by detailed process and economic evaluations . Discussion The Chinese government has prioritised prevention and treatment of diabetes as 1 of 11 National Basic Public Health Services . Despite great promise for mHealth interventions to improve access to effective health care , there remains uncertainty about how this can be successfully achieved . The findings are likely to inform policy on a scalable strategy to overcome sub-optimal access to effective health care in China . Trial registration Clinical trials.gov The purpose of this study was to test the extent that constructs from two theoretical models ( self-regulatory theory and social cognitive theory ) mediated change in outcomes following a self-management intervention .  One hundred and twenty four individuals with type 2 diabetes who had participated in a r and omised controlled trial of a diabetes self-management programme  were analysed for the extent that illness beliefs and self-efficacy mediated change in self-management behaviours and illness specific quality of life . Exercise specific self-efficacy significantly mediated change in exercise  at three months ( B = .03 ; .01 , p < .05 ) while  monitoring specific self-efficacy mediated change in monitoring behaviour at both three ( B = .04 ; .01 , p < .01 ) and nine months follow-up ( B = 5.97 ; 1.01 , p < .01 ) . Belief in control over diabetes mediated change in illness specific quality of life at three months ( B = −.07 ; .28 , p < .05 ) and nine months ( B = .79 ; .28 , p < .01 ) follow-ups , as well as change in exercise behaviour at immediately post-intervention ( B = −.12 ; .17 , p < .05 ) . Behaviour-specific self-efficacy may have a stronger role in mediating self-management behaviours than illness beliefs ; however , belief in control over diabetes may be important to manipulate for change in quality of life . This suggests different theoretical constructs may mediate change dependent on outcome Inadequate knowledge of the influence of lifestyle on clinical outcomes contributes to the difficulties many African Americans experience with type 2 diabetes mellitus ( T2DM ) . This pilot study examined a 12-week church-based culturally targeted diabetes self-management education ( DSME ) intervention for middle-aged and older African Americans with T2DM . Quantitative data were collected at baseline and at 12 weeks and included question naires and anthropometric measures . There were significant increases in medication adherence ( p = .006 ) , healthy eating ( p = .009 ) , and foot care adherence ( p = .003 ) . The intervention had a clinical ly significant effect on systolic blood pressure , blood lipids , physical activity , and waist circumference . Church-based culturally targeted DSME interventions may result in improved outcomes for African-American adults with T2DM . The authors discuss the value of community-based interventions that target behavioural changes in population s of chronically ill patients , particularly those who historically have been disenfranchised and /or underserved This pilot study evaluated an innovative diabetes symptom awareness and self-management educational program for Mexican Americans , a fast growing minority population experiencing a diabetes epidemic . Patients with diabetes need assistance interpreting and managing symptoms , which are often annoying and potentially life-threatening . A repeated measures r and omized controlled trial was conducted with 72 Mexican Americans aged 25 - 75 years with type 2 diabetes . Experimental condition participants received eight weekly , in-home , one-on-one educational and behavior modification sessions with a registered nurse focusing on symptom awareness , glucose self-testing and appropriate treatments , followed by eight biweekly support telephone sessions . Wait-listed control condition participants served as comparisons at three time points . Hierarchical linear modeling was used to evaluate the effects of the intervention between- and within groups on psychosocial , behavioral and clinical outcomes .  Participants were predominantly female , middle-aged , moderately acculturated and in poor glycemic control . Experimental group participants ( n = 39 ) significantly improved glycemic control , blood pressure , symptoms , knowledge , self-efficacy , empowerment and quality of life . Post intervention focus groups reported satisfaction with the symptom focus . Addressing symptoms led to clinical and psychosocial improvements . Symptoms seem to be an important motivator and a useful prompt to engage patients in diabetes self-management behaviors to relieve symptoms and prevent complications Background Multiple r and omized controlled trials ( RCTs ) show that behavioral lifestyle interventions are effective in improving diabetes management and that comprehensive risk factor management improves cardiovascular disease ( CVD ) outcomes . The role of technology has been gaining strong support as evidence builds of its potential to improve diabetes management ; however , evaluation of its impact in minority population s is limited . This study intends to provide early evidence of a theory-driven intervention , Tablet-Aided BehavioraL intervention EffecT on Self-management skills ( TABLETS ) , using real-time videoconferencing for education and skills training . We examine the potential for TABLETS to improve health risk behaviors and reduce CVD risk outcomes among a low-income African American ( AA ) population with poorly controlled type 2 diabetes . Methods The study is a two-arm , pilot controlled trial that r and omizes 30 participants to the TABLETS intervention and 30 participants to a usual care group . Blinded outcome assessment s will be completed at baseline , 2.5 months ( immediate post-intervention ) , and 6.5 months ( follow-up ) . The TABLETS intervention consists of culturally tailored telephone-delivered diabetes education and skills training delivered via videoconferencing on tablet devices , with two booster sessions delivered via tablet-based videoconferencing at 3 months and 5 months to stimulate ongoing use of the tablet device with access to intervention material s via videoconferencing slides and a manual of supplementary material s. The primary outcomes are physical activity , diet , medication adherence , and self-monitoring behavior , whereas the secondary outcomes are HbA1c , low-density lipoprotein cholesterol ( LDL-C ) , BP , CVD risk , and quality of life . Discussion This study provides a unique opportunity to assess the feasibility and efficacy of a theory-driven , tablet-aided behavioral intervention that utilizes real-time videoconferencing technology for education and skills training on self-management behaviors and quality of life among a high-risk , low-income AA population with an uncontrolled dyad or triad of CVD risk factors ( diabetes with or without hypertension or hyperlipidemia ) . The intervention leverages the use of novel technology for education and skill-building to foster improved diabetes self-management . The findings of this study will inform the process of disseminating the intervention to a broader and larger sample of people and can potentially be refined to align with clinical workflows that target a sub sample of patients with poor diabetes self-management . Trial registration The trial was registered in April 2014 with the United States National Institutes of Health Clinical Trials Registry ( Clinical Trials.gov identifier NCT02128854 ) , available online at : http:// clinical trials.gov/ct2/show/NCT02128854
The pooled main outcomes by r and om-effects model showed significant improvements in HbA1c , self-efficacy , and diabetes knowledge , but not in BMI .
As for quality of life , no conclusions can be drawn as the pooled outcome became the opposite with reduced heterogeneity after one study was excluded .
No significant publication bias was found in the main outcomes .
AIM To synthesize the effects of theory-based self-management educational interventions on patients with type 2 diabetes ( T2DM ) in r and omized controlled trials .
BACKGROUND Type 2 diabetes is a common chronic disease causing complications that put a heavy burden on society and reduce the quality of life of patients .
Good self-management of diabetes can prevent complications and improve the quality of life of T2DM patients .