A study protocol for a pilot randomised trial of a structured education programme for the self-management of Type 2 diabetes for adults with intellectual disabilities HeLP-Diabetes: randomised controlled trial protocol The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411] Randomised controlled trial of an automated, interactive telephone intervention to improve type 2 diabetes self-management (Telephone-Linked Care Diabetes Project): study protocol Therapeutic education among adults with type 2 diabetes: effects of a three-day intervention on perceived competence, self-management behaviours and glycaemic control Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial Delivering the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cost effectiveness analysis Pilot feasibility study examining a structured self‐management diabetes education programme, DESMOND‐ID, targeting HbA1c in adults with intellectual disabilities Do Internet-Based Support Interventions Change Perceptions of Social Support?: An Experimental Trial of Approaches for Supporting Diabetes Self-Management A cluster randomised controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol Behavioural interventions for type 2 diabetes: an evidence-based analysis. The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results. Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508] Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care REDEEM: A Pragmatic Trial to Reduce Diabetes Distress Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial Design and Methods for a Comparative Effectiveness Pilot Study: Virtual World vs. Face-to-Face Diabetes Self-Management Improving glycaemic control of patients with Type 2 diabetes in a primary care setting: a French application of the Staged Diabetes Management programme. Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial Patients' education, and its impact on care outcomes, resource consumption and working conditions: data from the International Diabetes Management Practices Study (IDMPS). Twelve-month outcomes of an Internet-based diabetes self-management support program.
Background The need for structured education programmes for type 2 diabetes is a high priority for many governments around the world . One such national education programme in the United Kingdom is the DESMOND Programme , which has been shown to be robust and effective for patients in general . However , these programmes are not generally targeted to people with intellectual disabilities ( ID ) , and robust evidence on their effects for this population is lacking . We have adapted the DESMOND Programme for people with ID and type 2 diabetes to produce an amended programme known as DESMOND-ID.This protocol is for a pilot trial to determine whether a large-scale r and omised trial is feasible , to test if DESMOND-ID is more effective than usual care in adults with ID for self-management of their type 2 diabetes , in particular as a means to reduce glycated haemoglobin ( Hb1Ac ) , improve psychological wellbeing and quality of life and promote a healthier lifestyle . This protocol describes the rationale , methods , proposed analysis plan and organisational and administrative details . Methods / Design This trial is a two arm , individually r and omised , pilot trial for adults with ID and type 2 diabetes , and their family and /or paid carers . It compares the DESMOND-ID programme with usual care .  Approximately 36 adults with mild to moderate ID will be recruited from three countries in the United Kingdom . Family and /or paid carers may also participate in the study . Participants will be r and omly assigned to one of two conditions using a secure computerised system with robust allocation concealment . A range of data will be collected from the adults with ID ( biomedical , psychosocial and self-management strategies ) and from their carers . Focus groups with all the participants will assess the acceptability of the intervention and the trial . Discussion The lack of appropriate structured education programmes and educational material s for this population leads to secondary health conditions and may lead to premature deaths . There are significant benefits to be gained globally , if structured education programmes are adapted and shown to be successful for people with ID and other cognitive impairments . Trial registration Registered with International St and ard R and omised Controlled Trial ( identifier : IS RCT N93185560 ) on 10 November 2014 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 The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinical ly effective ' Heart Manual ' . The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory . It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care . Methods / design In a two-group cluster r and omized controlled trial , GP practice s are allocated by computer minimisation to an intervention group or a six-month deferred intervention group . We aim to recruit 250 participants from 50 practice s across central Engl and . Eligibility criteria are adults able to undertake the programme with type 2 diabetes , not taking insulin , with HbA1c over 8 % ( first 12 months ) and following an agreed protocol change over 7 % ( months 13 to 18 ) . Following r and omisation , intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants . Deferred intervention nurses receive the training following six-month follow-up . Primary outcome is HbA1c with total and HDL cholesterol ; blood pressure , body mass index ; self-efficacy and quality of life as additional outcomes . Primary analysis is between-group HbA1c differences at 6 months powered to give 80 % power to detect a difference in HbA1c of 0.6 % . A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes , and a qualitative study is running alongside . Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes . The trial will increase our underst and ing of intervention transferability between conditions , those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes Background An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030 . For the year 2010 , it is estimated that 3.96 million excess deaths in the age group 20 - 79 years are attributable to diabetes around the world . Self-management is recognised as an integral part of diabetes care . This paper describes the protocol of a r and omised controlled trial of an automated interactive telephone system aim ing to improve the uptake and maintenance of essential diabetes self-management behaviours . Methods / Design A total of 340 individuals with type 2 diabetes will be r and omised , either to the routine care arm , or to the intervention arm in which participants receive the  Telephone-Linked Care ( TLC ) Diabetes program in addition to their routine care . The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months . They receive the study h and book and a glucose meter linked to a data uploading device . The TLC system consists of a computer with software design ed to provide monitoring , tailored feedback and education on key aspects of diabetes self-management , based on answers voiced or entered during the current or previous conversations . Data collection is conducted at baseline ( Time 1 ) , 6-month follow-up ( Time 2 ) , and 12-month follow-up ( Time 3 ) . The primary outcomes are glycaemic control ( HbA1c ) and quality of life ( Short Form-36 Health Survey version 2 ) . Secondary outcomes include anthropometric measures , blood pressure , blood lipid profile , psychosocial measures as well as measures of diet , physical activity , blood glucose monitoring , foot care and medication taking . Information on utilisation of healthcare services including hospital admissions , medication use and costs is collected . An economic evaluation is also planned . Discussion Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes . Furthermore , the study will provide insight into the potential for more widespread uptake of automated telehealth interventions , globally . Trial Registration The purpose of this study was to evaluate the impact of a three-day therapeutic education programme on perceived competence , self-management behaviours ( i.e. physical activity , diet and medication ) and glycaemic control among adults with type 2 diabetes . A total of 120 participants were included in this r and omized , wait list control group trial . The results confirm that therapeutic education may be a powerful healthcare intervention to improve lifestyle and health status of people with type 2 diabetes . We observed that the education programme used in this study generated positive changes in glycaemic control and adherence to physical activity and diet after three months follow-up . Furthermore , the intervention positively impacted participants ’ perceived competence towards physical activity and diet . The latter finding is of particular importance , given that perceived competence has been found to be involved in long-term adherence to self-management behaviours Background Addressing the increasing prevalence , and associated disease burden , of diabetes is a priority of health services internationally . Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications . The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment . Self-Management Support for Blood Glucose ( SMS4BG ) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences , demographics , clinical characteristics , and culture . This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes . This paper outlines the rationale and methods of the trial . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted across New Zeal and health districts . One thous and participants will be r and omised at a 1:1 ratio to receive SMS4BG , a theoretically based and individually tailored automated text message-based diabetes self-management support programme ( intervention ) in addition to usual care , or usual care alone ( control ) . The primary outcome is change in glycaemic control ( HbA1c ) at 9 months . Secondary outcomes include glycaemic control at 3 and 6 months , self-efficacy , self-care behaviours , diabetes distress , health-related quality of life , perceived social support , and illness perceptions . Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction . Discussion This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes . If found to be effective it has the potential to provide individualised support to people with diabetes across New Zeal and ( and internationally ) , thus extending care outside the clinic environment . Trial registration Australian New Zeal and Clinical Trials Registry : ACTRN12614001232628 Background Despite the efforts of the healthcare community to improve the quality of diabetes care , about 50 % of people with type 2 diabetes do not reach their treatment targets , increasing the risk of future micro- and macro-vascular complications . Diabetes self-management education has been shown to contribute to better disease control . However , it is not known which strategies involving educational programs are cost-effective . Telehealth applications might support chronic disease management . Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high method ological quality . “ The COACH Program ” was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions . It proved to be effective in patients with coronary heart disease after hospitalization . Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed . Methods / Design R and omized controlled trial in patients with type 2 diabetes . Patients were selected based on their medication consumption data and were recruited by their sickness fund . They were r and omized to receive either usual care plus “ The COACH Program ” or usual care alone . The study will assess the difference in outcomes between groups . The primary outcome measure is the level of HbA1c . The secondary outcomes are : Total Cholesterol , LDL-Cholesterol , HDL-Cholesterol , Triglycerides , Blood Pressure , body mass index , smoking status ; proportion of people at target for HbA1c , LDL-Cholesterol and Blood Pressure ; self-perceived health status , diabetes-specific emotional distress and satisfaction with diabetes care . The follow-up period is 18 months . Within-trial and modeled cost-utility analyses , to project effects over life-time horizon beyond the trial duration , will be undertaken from the perspective of the health care system if the intervention is effective . Discussion The study will enhance our underst and ing of the potential of telehealth in diabetes management in Belgium . Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions . Trial registration Belgian number : B322201213625 . Clinical Trials.gov Identifier : Objectives To assess the long term clinical and cost effectiveness of the diabetes education and self management for ongoing and newly diagnosed ( DESMOND ) intervention compared with usual care in people with newly diagnosed type 2 diabetes . Design We undertook a cost-utility analysis that used data from a 12 month , multicentre , cluster r and omised controlled trial and , using the Sheffield type 2 diabetes model , modelled long term outcomes in terms of use of therapies , incidence of complications , mortality , and associated effect on costs and health related quality of life . A further cost-utility analysis was also conducted using current “ real world ” costs of delivering the intervention estimated for a hypothetical primary care trust . Setting Primary care trusts in the United Kingdom . Participants Patients with newly diagnosed type 2 diabetes . Intervention A six hour structured group education programme delivered in the community by two professional healthcare educators . Main outcome measures Incremental costs and quality adjusted life years ( QALYs ) gained . Results On the basis of the data in the trial , the estimated mean incremental lifetime cost per person receiving the DESMOND intervention is £ 209 ( 95 % confidence interval −£704 to £ 1137 ; € 251 , −€844 to € 1363 ; $ 326 , −$1098 to $ 1773 ) , the incremental gain in QALYs per person is 0.0392 ( −0.0813 to 0.1786 ) , and the mean incremental cost per QALY is £ 5387 . Using “ real world ” intervention costs , the lifetime incremental cost of the DESMOND intervention is £ 82 ( −£831 to £ 1010 ) and the mean incremental cost per QALY gained is £ 2092 . A probabilistic sensitivity analysis indicated that the likelihood that the DESMOND programme is cost effective at a threshold of £ 20 000 per QALY is 66 % using trial based intervention costs and 70 % using “ real world ” costs . Results from a one way sensitivity analysis suggest that the DESMOND intervention  is cost effective even under more modest assumptions that include the effects of the intervention being lost after one year . Conclusion Our results suggest that the DESMOND intervention is likely to be cost effective compared with usual care , especially with respect to the real world cost of the intervention to primary care trusts , with reductions in weight and smoking being the main benefits delivered AIM To report on the outcomes of a pilot feasibility study of a structured self-management diabetes education programme targeting HbA1c . METHODS We conducted a two-arm , individually r and omized , pilot superiority trial for adults with intellectual disability and Type 2 diabetes mellitus . A total of 66 adults with disabilities across the UK met the eligibility criteria . Of these , 39 agreed to participate and were r and omly assigned to either the DESMOND-ID programme ( n = 19 ) or a control group ( n = 20 ) . The programme consisted of seven weekly educational sessions . The primary outcome was HbA1c level , and secondary outcomes included BMI , diabetes illness perceptions , severity of diabetes , quality of life , and attendance rates . RESULTS This study found that the DESMOND-ID programme was feasible to deliver . With reasonable adjustments , the participants could be recruited successfully , and could provide consent , complete the outcome measures , be r and omized to the groups and attend most of the sessions , with minimal loss to follow-up . The fixed-effects model , the interaction between occasion ( time ) and condition , showed statistically significant results ( 0.05 level ) for HbA1c ; however , the CI was large . CONCLUSION This is the first published study to adapt and pilot a national structured self-management diabetes education programme for adults with intellectual disability . This study shows it is possible to identify , recruit , consent and r and omize adults with intellectual disabilities to an intervention or control group . Internationally , the results of this pilot are promising , demonstrating that a multi-session education programme is acceptable and feasible to deliver . Its effectiveness should be further tested in an adequately powered trial Internet-based support groups are a rapidly growing segment of mutual aid programs for individuals with chronic illnesses and other challenges . Previous studies have informed us about the content of online exchanges between support group members , but we know little about the ability of these interventions to change participants ' perceptions of support . A r and omized trial of 160 adult Type 2 diabetes patients provided novice Internet users with computers and Internet access to 1 of 4 conditions :  (  a ) diabetes information only , ( b ) a personal self-management coach , ( c ) a social support intervention , or ( d ) a personal self-management coach and the support intervention . After 3 months , individuals in the 2 support conditions reported significant increases in support on a diabetes-specific support measure and a general support scale . Participants ' age was significantly related to change in social support , but intervention effects were still significant after accounting for this relationship . This report is a critical first step in evaluating the long-term effects of  Internet-based support for diabetes self-management . The discussion identifies directions for future research Background Patients with long-term conditions are increasingly the focus of quality improvement activities in health services to reduce the impact of these conditions on quality of life and to reduce the burden on care utilisation . There is significant interest in the potential for self-management support to improve health and reduce utilisation in these patient population s , but little consensus concerning the optimal model that would best provide such support . We describe the implementation and evaluation of self-management support through an evidence -based ' whole systems ' model involving patient support , training for primary care teams , and service re-organisation , all integrated into routine delivery within primary care . Methods The evaluation involves a large-scale , multi-site study of the implementation , effectiveness , and cost-effectiveness of this model of self-management support using a cluster r and omised controlled trial in patients with three long-term conditions of diabetes , chronic obstructive pulmonary disease ( COPD ) , and irritable bowel syndrome ( IBS ) . The outcome measures include healthcare utilisation and quality of life . We describe the methods of the cluster r and omised trial . Discussion If the ' whole systems ' model proves effective and cost-effective , it will provide decision-makers with a model for the delivery of self-management support for population s with long-term conditions that can be implemented widely to maximise ' reach ' across the wider patient population .Trial registration numberIS RCT N : IS RCT UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis  BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine whether behavioural interventions are effective in improving glycemic control in adults with type 2 diabetes . BACKGROUND Diabetes is a serious chronic condition affecting millions of people worldwide and is the sixth leading cause of death in Canada . In 2005 , an estimated 8.8 % of Ontario 's population had diabetes , representing more than 816,000 Ontarians . The direct health care cost of diabetes was $ 1.76 billion in the year 2000 and is projected to rise to a total cost of $ 3.14 billion by 2016 . Much of this cost arises from the serious long-term complications associated with the disease including : coronary heart disease , stroke , adult blindness , limb amputations and kidney disease . Type 2 diabetes accounts for 90 - 95 % of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older , prevalence in younger population s is increasing due to a rise in obesity and physical inactivity in children . Data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics . Despite physicians ' and patients ' knowledge of the importance of glycemic control , Canadian data has shown that only 38 % of patients with diabetes have HbA1C levels in the optimal range of 7 % or less . This statistic highlights the complexities involved in the management of diabetes , which is characterized by extensive patient involvement in addition to the support provided by physicians . An enormous dem and is , therefore , placed on patients to self-manage the physical , emotional and psychological aspects of living with a chronic illness . Despite differences in individual needs to cope with diabetes , there is general agreement for the necessity of supportive programs for patient self-management . While traditional programs were didactic models with the goal of improving patients ' knowledge of their disease , current models focus on behavioural approaches aim ed at providing patients with the skills and strategies required to promote and change their behaviour . Several meta-analyses and systematic review s have demonstrated improved health outcomes with  self-management support programs in type 2 diabetics . They have all , however , either looked at a specific component of self-management support programs ( i.e. self-management education ) or have been conducted in specific population s. Most review s are also qualitative and do not clearly define the interventions of interest , making findings difficult to interpret . Moreover , heterogeneity in the interventions has led to conflicting evidence on the components of effective programs . There is thus much uncertainty regarding the optimal design and delivery of these programs by policymakers . EVIDENCE -BASED ANALYSIS OF EFFECTIVENESS : RESEARCH QUESTIONS Are behavioural interventions  effective in improving glycemic control in adults with type 2 diabetes?Is the effectiveness of the intervention impacted by intervention characteristics ( e.g. delivery of intervention , length of intervention , mode of instruction , interventionist etc . ) ? INCLUSION CRITERIA English Language Published between January 1996 to August 2008 Type 2 diabetic adult population ( > 18 years)R and omized controlled trials ( RCTs ) Systematic review s , or meta-analyses Describing a multi-faceted self-management support intervention as defined by the 2007 Self-Management Mapping Guide (1)Reporting outcomes of glycemic control ( HbA1c ) with extractable data Studies with a minimum of 6-month follow up EXCLUSION CRITERIA Studies with a control group other than usual care Studies with a sample size < 30 Studies without a clearly defined intervention OUTCOMES OF INTEREST PRIMARY OUTCOME glycemic control ( HbA1c ) SECONDARY OUTCOMES systolic blood pressure ( SBP ) control , lipid control , change in smoking status , weight change , quality of life , knowledge , self-efficacy , managing psychosocial aspects of diabetes , assessing dissatisfaction and readiness to change , and setting and achieving diabetes goals . SEARCH STRATEGY A search was performed in OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , The Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1996 and August 2008 . Abstract s were review ed by a single author and studies meeting the inclusion criteria outlined above were obtained . Data on population characteristics , glycemic control outcomes , and study design were extracted . Reference lists were also checked for relevant studies . The quality of the evidence was assessed as being either high , moderate , low , or very low according to the GRADE methodology . SUMMARY OF FINDINGS The search identified 638 citations published between 1996 and August 2008 , of which 12 met the inclusion criteria and one was a meta- analysis ( Gary et al. 2003 ) . The remaining 11 studies were RCTs ( 9 were used in the meta- analysis ) and only one was defined as small ( total sample size N=47 ) . SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES : A total of 2,549 participants were included in the 11 identified studies . The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years . Most studies reported gender with a mean percentage of females of approximately 67 % . Of the eleven studies , two focused only on women and four included only Hispanic individuals . All studies evaluated type 2 diabetes patients exclusively . STUDY CHARACTERISTICS : The studies were conducted between 2002 and 2008 . Approximately six of 11 studies were carried out within the USA , with the remaining studies conducted in the UK , Sweden , and Israel ( sample size ranged from 47 to 824 participants ) . The quality of the studies ranged from moderate to low with four of the studies being of moderate quality and the remaining seven of low quality ( based on the Consort Checklist ) . Differences in quality were mainly due to method ological issues such as inadequate description of r and omization , sample size calculation allocation concealment , blinding and uncertainty of the use of intention-to-treat ( ITT ) analysis . Patients were recruited from several setting s : six studies from primary or general medical practice s , three studies from the community ( e.g. via advertisements ) , and two from outpatient diabetes clinics . A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group . INTERVENTION CHARACTERISTICS : All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide . The interventions most often focused on problem solving , goal setting and encouraging participants to engage in activities that protect and promote health ( e.g. modifying behaviour , change in diet , and increase physical activity ) . All of the studies examined comprehensive interventions targeted at least two self-care topics ( e.g. diet , physical activity , blood glucose monitoring , foot care , etc . ) . Despite the homogeneity in the aims of the interventions , there was substantial clinical heterogeneity in other intervention characteristics such as duration , intensity , setting , mode of delivery ( group vs. individual ) , interventionist , and outcomes of interest ( discussed below ) . DURATION , INTENSITY AND MODE OF DELIVERY : Intervention duration s ranged from 2 days to 1 year , with many falling into the range of 6 to 10 weeks . The rest of the interventions fell into categories of ≤ 2 weeks ( 2 studies ) , 6 months ( 2 studies ) , or 1 year ( 3 studies ) . Intensity of the interventions varied widely from 6 hours over 2 days , to 52 hours over 1 year ; however , the majority consisted of interventions of 6 to 15 hours . Both individual and group sessions were used to deliver interventions . Group counselling was used in five studies as a mode of instruction , three studies used both individual and group sessions , and one study used individual sessions as its sole mode of instruction . ( ABSTRACT BACKGROUND A prerequisite to translating research findings into practice is information on consistency of implementation , maintenance of results , and generalization of effects . This follow-up report is one of the few experimental studies to provide such information on Internet-based health education . METHODS We present follow-up data 10 months following r and omization on the " Diabetes Network ( D-Net ) " Internet-based self-management project , a r and omized trial evaluating the incremental effects of adding ( 1 ) tailored self-management training or ( 2 ) peer support components to a basic Internet-based , information-focused comparison intervention .  Participants were 320 adult type 2 diabetes patients from participating primary care offices , mean age 59 ( SD = 9.2 ) , who were relatively novice Internet users . RESULTS All intervention components were consistently implemented by staff , but participant website usage decreased over time . All conditions were significantly improved from baseline on behavioral , psychosocial , and some biological outcomes ; and there were few differences between conditions . Results were robust across on-line coaches , patient characteristics , and participating clinics . CONCLUSIONS The basic D-Net intervention was implemented well and improvements were observed across a variety of patients , interventionists , and clinics . There were , however , difficulties in maintaining usage over time and additions of tailored self-management and peer support components generally did not significantly improve results Background Care management programmes are an effective approach to care for high risk patients with complex care needs result ing from multiple co-occurring medical and non-medical conditions . These patients are likely to be hospitalized for a potentially " avoidable " cause . Nurse-led care management programmes for high risk elderly patients showed promising results . Care management programmes based on health care assistants ( HCAs ) targeting adult patients with a high risk of hospitalisation may be an innovative approach to deliver cost-efficient intensified care to patients most in need . Methods / Design PraCMan is a cluster r and omized controlled trial with primary care practice s as unit of r and omisation . The study evaluates a complex primary care practice -based care management of patients at high risk for future hospitalizations . Eligible patients either suffer from type 2 diabetes mellitus , chronic obstructive pulmonary disease , chronic heart failure or any combination . Patients with a high likelihood of hospitalization within the following 12 months ( based on insurance data ) will be included in the trial . During 12 months of intervention patients of the care management group receive comprehensive assessment of medical and non-medical needs and re sources as well as regular structured monitoring of symptoms . Assessment and monitoring will be performed by trained HCAs from the participating practice s. Additionally , patients will receive written information , symptom diaries , action plans and a medication plan to improve self-management capabilities . This intervention is addition to usual care . Patients from the  control group  receive usual care . Primary outcome is the number of all-cause hospitalizations at 12 months follow-up , assessed by insurance cl aims data . Secondary outcomes are health-related quality of life ( SF12 , EQ5D ) , quality of chronic illness care ( PACIC ) , health care utilisation and costs , medication adherence ( MARS ) , depression status and severity ( PHQ-9 ) , self-management capabilities and clinical parameters . Data collection will be performed at baseline , 12 and 24 months ( 12 months post-intervention ) . Discussion Practice -based care management for high risk individuals involving trained HCAs appears to be a promising approach to face the needs of an aging population with increasing care dem and s . Trial registration Current Controlled Trials IS RCT Background Care management interventions in the German health-care system have been evaluated with promising results , but further research is necessary to explore their full potential in the context of multi-morbidity . Our aim in this trial is to assess the efficacy of a primary care practice network – based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions . Methods / Design The study is design ed as a prospect i ve , 18-month , multicentre , investigator-blinded , two-arm , open-label , individual-level , r and omized parallel-group superiority trial . We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient . Data will be collected at baseline ( T0 ) , at the primary endpoint after 9 months ( T1 ) and at follow-up after 18 months ( T2 ) . The primary outcome will be the differences between the  intervention and control groups  in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities ( SDSCA-G ) . The secondary outcomes will be the differences between the intervention and control groups in : changes in scores on the SDSCA-G subscales , glycosylated haemoglobin A level , health-related quality of life , self-efficacy , differences in ( severe ) symptomatic hypoglycaemia , cost-effectiveness and financial family burden . The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements : ( 1 ) three home visits , including structured assessment of medical and social needs ; ( 2 ) 24 structured telephone monitoring contacts ; and ( 3 ) self-monitoring of blood glucose levels after T1 in 3-month intervals . The control group will receive usual care . The confirmatory primary analysis will be performed following the intention-to-treat ( ITT ) principle . The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle . In health economic evaluations , we will estimate the incremental cost-effectiveness ratios . Discussion We hope that the results of this study will provide insights into the efficacy of practice network – based care management among patients with complex health-care needs . Trial registration Current Controlled Trials IS RCT N83908315 ( IS RCT N assigned 25 February 2014 ) Objective To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years . Design Three year follow-up of a multicentre cluster r and omised controlled trial in primary care , with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 731 of the 824 participants included in the original trial were eligible for follow-up . Biomedical data were collected on 604 ( 82.6 % ) and question naire data on 513 ( 70.1 % ) participants . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures The primary outcome was glycated haemoglobin ( HbA1c ) levels . The secondary outcomes were blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , emotional impact of diabetes , and drug use at three years . Results HbA1c levels at three years had decreased in both groups . After adjusting for baseline and cluster the difference was not significant ( difference −0.02 , 95 % confidence interval −0.22 to 0.17 ) . The groups did not differ for the other biomedical and lifestyle outcomes and drug use . The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years ( P<0.01 ) . Depression scores and quality of life did not differ at three years . Conclusion A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs . Trial registration Current Controlled Trials IS RCT N17844016 OBJECTIVE To compare three interventions to reduce diabetes distress ( DD ) and improve self-management among non– clinical ly depressed adults with type 2 diabetes mellitus ( T2DM ) . RESEARCH DESIGN AND METHODS In REDEEM , 392 adults with T2DM and DD were r and omized to computer-assisted self-management ( CASM ) , CASM plus DD-specific problem solving ( CAPS ) , or a computer-administered minimal supportive intervention . Primary outcomes were Diabetes Distress Scale ( DDS ) total , the Emotional Burden ( EB ) and Regimen Distress ( RD ) DDS subscales , and diet , exercise , and medication adherence . RESULTS Significant and clinical ly meaningful reductions in DD ( DDS , EB , and RD ) and self-management behaviors occurred in all three conditions ( P < 0.001 ) , with no significant between-group differences . There was , however , a significant group × baseline distress interaction ( P < 0.02 ) , in which patients with high baseline RD in the CAPS condition displayed significantly larger RD reductions than those in the other two conditions . RD generated the most distress and displayed the greatest distress reduction as a result of intervention . The pace of DD reduction varied by patient age : older patients demonstrated significant reductions in DD early in the intervention , whereas younger adults displayed similar reductions later . Reductions in DD were accompanied by significant improvements in healthy eating , physical activity , and medication adherence , although not by change in HbA1c . CONCLUSIONS DD is malleable and highly responsive to intervention . Interventions that enhance self-management also reduce DD significantly , but DD-specific interventions may be necessary for patients with high initial levels of DD . Future research should identify the minimal , most cost-effective interventions to reduce DD and improve self-management Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33 % have been recorded in Cape Town . Previous studies show that quality of care and health outcomes are poor . The development of an effective education programme should impact on self-care , lifestyle change and adherence to medication ; and lead to better control of diabetes , fewer complications and better quality of life . Methods Trial design : Pragmatic cluster r and omized controlled trial Participants : Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions : The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style . The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room . Objective : To evaluate the effectiveness of the group diabetes education programme Outcomes : Primary outcomes : diabetes self-care activities , 5 % weight loss , 1 % reduction in HbA1c . Secondary outcomes : self-efficacy , locus of control , mean blood pressure , mean weight loss , mean waist circumference , mean HbA1c , mean total cholesterol , quality of life R and omisation : Computer generated r and om numbers Blinding : Patients , health promoters and research assistants could not be blinded to the health centre ’s allocation Numbers r and omized : Seventeen health centres ( 34 in total ) will be r and omly assigned to either control or intervention groups . A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80 % to detect the primary outcomes with 5 % precision . Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570 . Discussion The study will inform policy makers and managers of the district health system , particularly in low to middle income countries , if this programme can be implemented more widely . Trial registerPan African Clinical Trial Registry Background Type 2 diabetes ( diabetes ) is a serious threat to public health in the United States and disproportionally affects many racial/ethnic minority groups , including African Americans . Limited access to treatment and high attrition rates further contribute to health disparities in diabetes-related morbidity and mortality among minorities . Greater opportunities for increasing access and decreasing barriers to treatment are needed . Technology-based interventions have potential for accomplishing this goal but evidence of feasibility and potential effectiveness is lacking , especially for population s that traditionally have limited educational attainment and low computer literacy . Objective This paper describes the design and methods of a pilot r and omized clinical trial that will compare the feasibility and potential efficacy of delivering a diabetes self-management intervention via a virtual world vs. a face-to-face format . Methods Study participants ( n=100 ) will be African American women with uncontrolled type 2 diabetes recruited from primary care practice s and affiliated health centers at a large safety net hospital in Massachusetts . Participants will be r and omized into a virtual world-based ( VW ) intervention condition or a face-to-face control condition . Both conditions provide the same theory-based curriculum and equivalent exposure to the self-management program ( eight group sessions ) , and both will be delivered by a single intervention team ( a dietitian and a diabetes educator ) . Assessment s will be conducted at baseline and 4 months . Feasibility will be determined by evaluating the degree to which participants engage in the VW-based intervention compared to face to face ( number of sessions completed ) . Potential efficacy will be determined by comparing change in physiological ( glycemic control ) and behavioral ( self-reported dietary intake , physical activity , blood glucose self-monitoring , and medication adherence ) outcomes between the experimental and control groups . Results The primary outcomes of interest are feasibility of the VW intervention and its potential efficacy on glucose control and diabetes self-management behaviors , compared to the face-to-face condition . Analysis will use a two- sample Kolmogorov-Smirnov test for changes in variable distribution . P values will be calculated using binomial tests for proportions and t tests for continuous variables . Conclusions If the intervention is found to be feasible and promising , it will be tested in a larger RCT AIMS To assess the impact of a French adaptation of the Staged Diabetes Management ( SDM ) programme on glycaemic control of people with Type 2 diabetes in primary care . Secondary endpoints were blood pressure , blood lipids , healthcare costs and quality of life . METHODS Prospect i ve , r and omized controlled study , of 1 years ' duration . General practitioners ( GPs ) were recruited in four separate districts of a French region . They enrolled consecutive patients with Type 2 diabetes . GPs in the intervention group were educated in the SDM programme . GPs in the control group were asked to provide usual care .  Healthcare costs were collected by medical departments of the Health Insurance systems . Quality of life was assessed with the Duke Health Profile . RESULTS Three hundred and forty patients enrolled by 57 GPs completed the study , 192 in the intervention group and 148 in the control group . Patients in the intervention group were managed more adequately in accordance with the guidelines ( P < 0.05 for nine out of 10 items ) . HbA(1c ) decreased by 0.31 % in the intervention group and increased by 0.56 % in the control group , result ing in a difference of 0.87 % by the end of the study ( P = 0.001 ) . Blood pressure and blood lipids did not differ between groups . Occurrence of major complications was low and identical in both groups . Incremental costs during the study in the intervention group were 35 euros per patient per month , and this was not significantly different in comparison with the control group . Quality of life was not affected by the intervention . CONCLUSIONS Educating GPs in the French adaptation of the SDM programme improves glycaemic control in a primary care setting , without significantly increasing healthcare costs Objective . To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes ( GDM ) . Design . A two-group , mixed methods r and omized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were r and omly assigned to intervention ( n = 24 ) or wait control ( n = 26 ) and postintervention qualitative interviews with participants . Main Outcome Measures . Modifiable biochemical , anthropometric , behavioural , and psychosocial risk factors associated with the development of type 2 diabetes . The primary outcome variable was the change in fasting plasma glucose ( FPG ) from study entry to one-year follow-up . Results . At one-year follow-up , the intervention group showed significant improvements over the wait control group on stress , diet self-efficacy , and quality of life . There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry ; the effect on one health behaviour , diet adherence , was close to significance . Conclusions . Prevention programmes must tackle the barriers to participation faced by this population ; home-based interventions should be investigated . Strategies for promoting long-term health self-management need to be developed and tested 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 OBJECTIVE Internet-based programs offer potential for practical , cost-effective chronic illness self-management programs . METHODS We report 12-month results of an Internet-based diabetes self-management program , with and without additional support , compared to enhanced usual care in a 3-arm practical r and omized trial . Patients ( n=463 ) were r and omized : 77.3 % completed 12-month follow-up . Primary outcomes were changes in health behaviors of healthy eating , physical activity , and medication taking . Secondary outcomes were hemoglobin A1c , body mass index , lipids , blood pressure , and psychosocial factors . RESULTS Internet conditions  improved health behaviors significantly vs. usual care over the 12-month period ( d for effect size=.09-.16 ) . All conditions improved moderately on biological and psychosocial outcomes .  Latinos , lower literacy , and higher cardiovascular disease risk patients improved as much as other participants . CONCLUSIONS The Internet intervention meets the reach and feasibility criteria for a potentially broad public health impact . However , 12-month magnitude of effects was small , suggesting that different or more intensive approaches are necessary to support long-term outcomes . Research is needed to underst and the linkages between intervention and maintenance processes and downstream outcomes . PRACTICE IMPLICATION S Automated self-management interventions should be tailored and integrated into primary care ; maintenance of patient self-management can be enhanced through links to community re sources
There were three reported  deaths out of 3578 participants .Computer-based  diabetes self-management interventions currently have limited effectiveness .
Current interventions do not show adequate evidence for improving depression , health-related quality of life or weight .
AUTHORS ' CONCLUSIONS Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control and the effect was larger in the mobile phone subgroup .
There is no evidence to show benefits in other biological outcomes or any cognitive , behavioural or emotional outcomes
BACKGROUND Diabetes is one of the commonest chronic medical conditions , affecting around 347 million adults worldwide .
Structured patient education programmes reduce the risk of diabetes-related complications four-fold .
Internet-based self-management programmes have been shown to be effective for a number of long-term conditions , but it is unclear what are the essential or effective components of such programmes .
If computer-based self-management interventions improve outcomes in type 2 diabetes , they could potentially provide a cost-effective option for reducing the burdens placed on patients and healthcare systems by this long-term condition .
OBJECTIVES To assess the effects on health status and health-related quality of life of computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus .