A people-centred approach through Self-Management and Reciprocal learning for the prevention and management of Type 2 Diabetes

• Register: ISRCTN
• Last refreshed on: 10 April 2023
• Main ID: ISRCTN11913581
• Date of registration: 10/01/2017
• Prospective Registration: Yes
• Primary sponsor: European Commission
• Public title: A people-centred approach through Self-Management and Reciprocal learning for the prevention and management of Type 2 Diabetes
• Scientific title: Implementation of a contextualized self-management approach to prevent and manage type 2 diabetes
• Date of first enrolment: 30/01/2017
• Target sample size: 1869
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11913581
• Study type: Interventional
• Study design: Study design as of 01/10/2018: Pragmatic cluster randomised trial in South Africa and Uganda and Sweden. The Swedish component focuses on feasibility of implementation. Previous study design: Pragmatic cluster randomised trial (Other)
• Phase: Not Applicable

Countries of recruitment

South Africa, Sweden, Uganda

Contacts

• Name: Linda Timm

• Name: Francis Kasujja

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria as of 01/10/2018:
1. Currently residing in, and have resided in their respective communities for at least 6 months prior to enrolment
2. Aged between 30 – 75 years
3. Have no plans of migrating out of the study area over the next 12 months from the date of enrolment
4. Able to provide written informed consent
5. Agree to home visits and follow-up contacts as part of study participation
6. Have not been previously diagnosed with diabetes for longer than 12 months
7. Have a positive confirmatory test of pre-diabetes or diabetes

Previous inclusion criteria:
1. Current residents who have resided in their respective communities for at least 6 months prior to enrolment into the study
2. Aged 30 – 75 years
3. Able to provide written informed consent
4. Agree to allow home visits or follow-up contacts as part of participating in the trial
5. Have a positive confirmatory test of pre-diabetes or diabetes following screening or within past 12 months of trial start. In Sweden, this includes high risk of diabetes based on FINDRISC scores.


Previous inclusion criteria as of 16/10/2017:
1. Currently residing in, and have resided in their respective communities for at least 6 months prior to enrollment
2. Aged between 30 – 75 years
3. Have no plans of migrating out of the study area over the next 12 months from the date of enrollment
4. Able to provide written informed consent
5. Agree to home visits and follow-up contacts as part of study participation
6. Have not been previously diagnosed with diabetes for longer than 12 months
7. Have a positive confirmatory test of pre-diabetes or diabetes

Previous inclusion criteria:
1. Current residents who have resided in their respective communities for at least 6 months prior to enrollment into the study
2. Aged 30 – 75 years
3. Able to provide written informed consent
4. Agree to allow home visits or follow-up contacts as part of participating in the trial
5. Have a positive confirmatory test of pre-diabetes or diabetes following screening or within past 12 months of trial start

Exclusion criteria:
Current exclusion criteria as of 16/10/2017:
1. Pregnancy
2. Serious mental disability

Previous exclusion criteria:
1. Currently known to be pregnant
2. Plans of migrating out of the study area over the next 12 months from the date of enrollment into the study
3. Previous diagnosis of diabetes, 12 months prior to enrollment into the study


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 diabetes and pre-diabetes
Nutritional, Metabolic, Endocrine
Type 2 diabetes and pre-diabetes

Intervention(s)

Intervention as of 01/10/2018:
Health facilities and their catchment areas are designated as clusters. Clusters are randomized to either a facility-only intervention arm (defined as standard facility-based care, which is usually the routine care), or a facility + community intervention arm (standard facility-based care complemented by community components). Since routine care in Uganda is inadequate, they have a third comparison arm of routine care.

Control arm: Participants in the control arm receive standard facility-based care as represented by standardized routine facility care in each setting. This involves the:
1. Organization of care process to ensure the availability of functioning minimal infrastructure and equipment needed for diagnosis and treatment of type 2 diabetes and the use of appropriate diagnostic and treatment guidelines
2. Strengthening patient role in self-management through a behavioural coaching component during baseline and follow-up visits, providing participants with an overview of their care process and their role and access to measuring devices to self-monitor weight, blood pressure or blood sugar as required.

Intervention arm: Participants will receive a community component through a linked peer support system in addition to the standard facility-based care. The community component includes:
1. Community mobilization through messages on lifestyle and diabetes for community member and key stakeholders
2. Strengthening support from the environment for diabetes prevention and management through a participant peer group programme and care companions or healthy lifestyle buddies and the promotion of a supportive phys

Primary Outcome(s)

Plasma glucose, as measured by HbA1c levels between baseline and 12 months

Secondary Outcome(s)

1. Incidence of diabetes as measured by HbA1c levels between baseline and 12 months
2. Incidence of conversion from pre-diabetes state to normal plasma glucose level state as measured by HbA1c levels between baseline and 12 months
3. Adverse events, including hospitalizations due to hypo- or hyperglycemia, morbidity, as measured by self-reported data using interview schedules at month 12
4. Incremental costs to the system related to implementation of the intervention as estimated through costing questionnaire for facility and community components between months 3-10
5. Out-of-pocket expenditure for diabetes – comparison between country sites and change in cost to the individual – through self-reported out-of-pocket expenditure using interview schedules at baseline and 12 months
6. Evaluation of the intervention process through Likert-scaled questionnaires, focusing on treatment satisfaction, knowledge about diabetes, autonomy support, self-efficacy, social support and sources of support, measured at baseline and 12 months
7. Differences between the country sites, in regard to baseline contextual factors relating to infrastructure, guidelines and personnel for prevention and management of diabetes as measured by facility checklist questionnaires between months 3-10
8. Degree of implementation of the intervention elements in each country, and differences between the country sites, through a process evaluation at each site using tracking forms, checklists and qualitative methods between months 2-11
9. Differences between the country sites, and changes within these contexts, as a result of implementing the intervention elements such as stigma towards overweight or obese individuals, security concerns in public spaces, and collaboration between primary care, municipalities and local networks through qualitative methods after 10 months
10. Assessment of the food environment in each site and comparison between the three country sites using a modified EPOCH (Environmental Profile of a Country’s Health) questionnaire between months 6-10

Secondary ID(s)

643692

Source(s) of Monetary Support

European Commission

Secondary Sponsor(s)

Swedish International Development Agency

Karolinska Institutet Research Foundation Grants for young scientists

Ethics review

Status:
Approval date:
Contact:

Current ethics approvals: 1. Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health (426) 2. Uganda National Council for Science and Technology (HS 2118) 3. South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape (BM/17/1/36) 4. Sweden from the Regional Ethical Board in Stockholm (2016/2521-31/1)

Results

• Results available: Yes
• Date Completed: 31/03/2019