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Intervention for Diabetes with Education, Advancement and Support (IDEAS) study: protocol for a cluster randomised controlled trial.

ABSTRACT: The high market penetration of mobile phones has triggered an opportunity to combine mobile technology with health care to overcome challenges in today's health care setting. Although Malaysia has a high Internet and mobile penetration rate, evaluations of the efficacy of incorporating this technology in diabetes care is not common. We report the development of a telemonitoring coaching system, using the United Kingdom (UK) Medical Research Council (MRC) framework, for patients with type 2 diabetes mellitus.The Intervention for Diabetes with Education, Technological Advancement and Support (IDEAS) study is a telemonitoring programme based on an empowerment philosophy to enable participants to be responsible for their own health decision and behaviour. An iterative cycle of development, piloting, and collating qualitative and quantitative data will be used to inform and refine the intervention. To increase compliance, the intervention will be designed to encourage self-management using simple, non-technical knowledge. The primary outcomes will be HbA1c, blood pressure, total cholesterol, and quality of life and diabetes self-efficacy. In addition, an economic analysis on health service utilisation will be collected.The mixed-method approach in this study will allow for a holistic overview of using telemonitoring in diabetes care. This design enables researchers to understand the effectiveness of telemonitoring as well as provide insights towards the receptiveness of incorporating information technology amongst type 2 diabetes patients in a community setting.ClinicalTrials.gov NCT02466880 Registered 2 June 2015.

SUBMITTER: Lee JY

PROVIDER: S-EPMC5041520 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Intervention for Diabetes with Education, Advancement and Support (IDEAS) study: protocol for a cluster randomised controlled trial.

Lee Jun Yang JY Chan Carina Ka Yee CK Chua Siew Siang SS Ng Chirk Jenn CJ Paraidathathu Thomas T Lee Kenneth Kwing-Chin KK Lee Shaun Wen Huey SW

BMC health services research 20160929 1

<h4>Background</h4>The high market penetration of mobile phones has triggered an opportunity to combine mobile technology with health care to overcome challenges in today's health care setting. Although Malaysia has a high Internet and mobile penetration rate, evaluations of the efficacy of incorporating this technology in diabetes care is not common. We report the development of a telemonitoring coaching system, using the United Kingdom (UK) Medical Research Council (MRC) framework, for patient ...[more]

PMID: 27683021

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Project description:ObjectiveTo test the effectiveness of peer support for patients with type 2 diabetes.DesignCluster randomised controlled.Setting20 general practices in the east of the Republic of Ireland.Participants395 patients (192 in intervention group, 203 in control group) and 29 peer supporters with type 2 diabetes.InterventionAll practices introduced a standardised diabetes care system. The peer support intervention ran over a two year period and contained four elements: the recruitment and training of peer supporters, nine group meetings led by peer supporters in participant's own general practice, and a retention plan for the peer supporters.Main outcome measuresHbA(1c); cholesterol concentration; systolic blood pressure; and wellbeing score.ResultsThere was no difference between intervention and control patients at baseline. All practices and 85% (337) of patients were followed up. At two year follow-up, there were no significant differences in HbA(1c) (mean difference -0.08%, 95% confidence interval -0.35% to 0.18%), systolic blood pressure (-3.9 mm Hg, -8.9 to 1.1 mm Hg), total cholesterol concentration (-0.03 mmol/L, -0.28 to 0.22 mmol/L), or wellbeing scores (-0.7, -2.3 to 0.8). While there was a trend towards decreases in the proportion of patients with poorly controlled risk factors at follow-up, particularly for systolic blood pressure (52% (87/166) >130 mm Hg in intervention v 61% (103/169) >130 mm Hg in control), these changes were not significant. The process evaluation indicated that the intervention was generally delivered as intended, though 18% (35) of patients in the intervention group never attended any group meetings.ConclusionsA group based peer support intervention is feasible in general practice settings, but the intervention was not effective when targeted at all patients with type 2 diabetes. While there was a trend towards improvements of clinical outcomes, the results do not support the widespread adoption of peer support. Trial registration Current Controlled Trials ISRCTN42541690.

Project description:IntroductionEvidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP.Methods and analysesThis is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18-64 years, and permanent residents of study sites. HbA1c test will be only performed if both Indian Diabetes Risk Score and random blood sugar value are ≥60 and 140-250 mg/dL, respectively. At baseline, participants in intervention arm will receive DiPEP package (including intensive intervention classes, diabetes prevention brochure, exercise calendar and food record booklet), and participants in control arm will be provided only with diabetes prevention brochure. The change in outcome measures will be compared between intervention to control arm after 6 months of follow-up by linear mixed models. Also, we will conduct individual interviews among participants and healthcare workers as part of a qualitative study. We will use thematic analysis to analyse qualitative data.Ethics and disseminationRegional Committee for Medical and Health Research Ethics, Norway; Nepal Health Research Council, Nepal and Institutional Review Committee, Kathmandu University School of Medical Sciences have approved the study. The DiPEP package can be implemented in other communities of Nepal if it is effective in preventing diabetes.Trial registration numberNCT04074148, 2019/783.

Project description:BackgroundBlack men are more likely to be diagnosed with type 2 diabetes (T2D) compared to non-Hispanic White men, and this disparity increases among men over the age of 55. A growing body of literature demonstrates the critical role of gender in the management of health behaviors such as T2D and shows that male gender norms can conflict with healthy behaviors. These studies suggest that tailoring diabetes self-management interventions to address the needs of Black men may be critical to helping them to achieve optimal health outcomes. Further, our own research on Blacks with T2D found gender disparities in participation in diabetes interventions, with males participating at significantly lower rates than females. Peer leaders are trained lay individuals who are used to provide ongoing diabetes self-management support to people with diabetes, particularly in minority communities. However, despite studies showing that diabetes management interventions using peer leaders have been successful, the majority of peer leaders as well as the participants in those studies are women. The limited studies to date suggest that Black men with T2D prefer peer-led, male-to-male T2D programs, however, this research consists primarily of nonrandomized, small sample feasibility studies calling for additional studies to establish the efficacy of these approaches. The proposed study will develop and preliminarily validate the effectiveness of an adapted peer leader diabetes self-management support (PLDSMS) intervention designed to improve diabetes-related lifestyle and self-management behaviors in Black men (over 55) with T2D.MethodWe propose to tailor an existing intervention by 1) our using male peers and 2) modifying the peer leader training content to focus on material appropriate for men. The proposed study includes a developmental phase (development of the intervention with expert feedback, followed by feasibility testing with Black men) and a validation phase [randomized clinical trial (RCT)].DiscussionIf successful, this study will lead to the development and dissemination of an intervention that will address the unique needs of Black men with T2D, helping them to achieve optimal diabetes self-management and health outcomes.Trial registrationRegistered at ClinicalTrials.gov with an ID NCT04760444 on February 17, 2021.

Project description:BackgroundDaily physical activity is critical during the early years of life for facilitating children's health and development. A large proportion of preschool children do not achieve the recommended 3 h of daily physical activity. Early childhood education and care (ECEC) services are a key setting to intervene to increase physical activity. There is a significant need for ECEC specific physical activity policy, including clearer guidelines on the amount of physical activity children should do during care, and strategies for implementation of these guidelines.MethodsThis study is a pragmatic cluster randomised trial to evaluate the effectiveness of the Play Active physical activity policy intervention to improve early childhood education and care educator's physical activity-related practices. The central component of Play Active is an evidence-informed physical activity policy template which includes 25 practices to support nine age-specific recommendations on the amount of physical activity and sedentary time, including screen time, young children should do while in care. There are six implementation support strategies to facilitate physical activity policy implementation: (i) personalise policy (services select at least five of the 25 practices to focus on initially); (ii) policy review and approval; (iii) a resource guide; (iv) a brief assessment tool for monitoring children's energetic play; (v) professional development; and (vi) Project Officer implementation support (phone calls). A total of 60 early childhood education and care services will be recruited from metropolitan Perth, Western Australia. After baseline assessment, services will be randomly allocated to either intervention or wait-listed comparison conditions. Primary (educator-reported frequency and amount of daily time provided for children's physical activity, sedentary and screen time) and secondary (educator physical activity-related practices, self-efficacy, motivation, attitudes and beliefs, social support, and supportive physical environment) outcomes will be assessed at baseline and post-intervention, after intervention services have had a minimum 3 months of policy implementation within their service.DiscussionThe Play Active trial will rigorously evaluate a novel physical activity policy intervention with implementation support that promotes positive physical activity behaviours in educators and children attending ECEC. If effective, the program could be adapted, scaled-up and delivered in ECEC services nationally.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12620001206910 (date of registration 13/11/2020).

Project description:To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams.Process evaluation nested within a cluster randomised controlled trial (RCT).28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports.14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention.The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles.Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure.Controlled-Trials.com ISRCTN02507940.

Project description:Adolescence offers a window of opportunity during which improvements in health behaviours could benefit long-term health, and enable preparation for parenthood-albeit a long way off, passing on good health prospects to future children. This study was carried out to evaluate whether an educational intervention, which engages adolescents in science, can improve their health literacy and behaviours. A cluster-randomised controlled trial of 38 secondary schools in England, UK was conducted. The intervention (LifeLab) drew on principles of education, psychology and public health to engage students with science for health literacy, focused on the message "Me, my health and my children's health". The programme comprised: • Professional development for teachers. • A 2-3 week module of work for 13-14-year-olds. • A "hands-on" practical health science day visit to a dedicated facility in a university teaching hospital. Data were collected from 2929 adolescents (aged 13-14 years) at baseline and 2487 (84.9%) at 12-month follow-up. The primary outcome was change in theoretical health literacy from pre- to 12 months post- intervention. This study is registered (ISRCTN71951436) and the trial status is complete. Participation in the LifeLab educational intervention was associated with an increase in the students' standardised total theoretical health literacy score (adjusted difference between groups = 0.27 SDs (95%CI = 0.12, 0.42)) at 12-month follow-up. There was an indication that intervention participants subsequently judged their own lifestyles more critically than controls, with fewer reporting their behaviours as healthy (53.4% vs. 59.5%; adjusted PRR = 0.94 [0.87, 1.01]). We conclude that experiencing LifeLab led to improved health literacy in adolescents and that they demonstrated a move towards a more critical judgement of health behaviour 12 months after the intervention. Further work is needed to examine whether this leads to sustained behaviour change, and whether other activities are needed to support this change.

Project description:INTRODUCTION:Type 2 diabetes mellitus (T2DM) and its complications are more common among M?ori and Pacific people compared with other ethnic groups in New Zealand. Comprehensive and sustained approaches that address social determinants of health are required to address this condition, including culturally specific interventions. Currently, New Zealand has no comprehensive T2DM management programme for M?ori or Pacific people. METHODS AND ANALYSIS:The Mana T? programme was developed by a M?ori-led collaborative of primary healthcare workers and researchers, and codesigned with wh?nau (patients and their families) in order to address this gap. The programme is based in primary care and has three major components: a Network hub, Kai Manaaki (skilled case managers who work with wh?nau with poorly controlled diabetes) and a cross-sector network of services to whom wh?nau can be referred to address the wider determinants of health. The Network hub supports the delivery of the intervention through training of Kai Manaaki, referrals management, cross-sector network development and quality improvement of the programme. A two-arm cluster randomised controlled trial will be conducted to evaluate the effectiveness of the Mana T? programme among M?ori, Pacific people or those living in areas of high socioeconomic deprivation who also have poorly controlled diabetes (glycated haemoglobin, HbA1c, >65?mmol/mol (8%)), compared with being on a wait list for the programme. A total of 400 participants will be included from 10 general practices (5 practices per group, 40 participants per practice). The primary outcome is HbA1c at 12 months. Secondary outcomes include blood pressure, lipid levels, body mass index and smoking status at 12 months. This protocol outlines the proposed study design and analysis methods. ETHICS AND DISSEMINATION:Ethical approval for the trial has been obtained from the New Zealand Health and Disability Ethics Committee (17/NTB/249). Findings will be presented to practices and their patients at appropriate fora, and disseminated widely through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617001276347; Pre-result.

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Intervention for Diabetes with Education, Advancement and Support (IDEAS) study: protocol for a cluster randomised controlled trial.

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Intervention for Diabetes with Education, Advancement and Support (IDEAS) study: protocol for a cluster randomised controlled trial.

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