Behavioural medicine for lower-educated patients with type 2 diabetes: the effectiveness and implementation of a tailored intervention in primary care
| ISRCTN | ISRCTN12982302 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12982302 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 555003202 |
| Sponsor | Amsterdam University Medical Centers |
| Funder | ZonMw |
- Submission date
- 21/03/2022
- Registration date
- 29/03/2022
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This study is focused on behavioural medicine for lower educated type 2 diabetes patients. This study aims to test the effectiveness of a behavioural programme in lower educated type 2 diabetes patients in primary care.
Who can participate?
Eligible participants are between 35 and 70 years old and should be diagnosed at least one year with type 2 diabetes.
What does the study involve?
Patients in the intervention group will receive the behavioural programme 'Powerful together with diabetes' for 27 weeks in weekly group sessions, patients in the control group receive standard care. The 'Powerful together with diabetes' programme aims to support and empower patients to improve their diabetes self-management such as control of blood sugar levels (glycaemic control) and medication adherence. Improvement in glycaemic control will be compared across the intervention and control groups using data from routinely collected blood samples. Participants will also complete questionnaires on their quality of life throughout the study.
What are the possible benefits and risks of participating?
The benefits of participating are that patients' glycaemic control is improved and improvement of their medication adherence and quality of life.
Where is the study run from?
Amsterdam UMC, location AMC (Netherlands)
When is the study starting and how long is it expected to run for?
From February 2021 to October 2025
Who is funding the study?
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Who is the main contact?
Bedra Horreh
b.horreh@amsterdamumc.nl
Contact information
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
 ORCID ID |
0000-0002-7659-1180 |
|---|---|
| Phone | 0031205666229 |
| b.horreh@amsterdamumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single center interventional quasi-experimental non-randomized trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | The DISC-2 (Diabetes in Social Context) study: an effectiveness-implementation hybrid evaluation of a group-based self-management intervention for lower educated T2DM patients |
| Study acronym | DISC-2 |
| Study objectives | Glycaemic control is improved in patients receiving the behavioural programme 'Powerful together with diabetes' as compared to patients not receiving the programme. |
| Ethics approval(s) | Approved 07/02/2022, Medical Ethics Committee of the Academic Medical Center (AMC), (Meibergdreef 9, 1105 AZ, Amsterdam; +310205667389; mecamc@amsterdamumc.nl), ref: 2021_222 - NL79337.018.21 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | Current interventions as of 16/10/2024: Patients in GP practices receive in the intervention group the 'Powerful together with diabetes' program in 27 weekly group sessions. Patients in the control group receive standard care. _____ Previous interventions: Patients in GP practices receive in the intervention group the 'Powerful together with diabetes' program for 1 year in weekly group sessions. Patients in the control group receive standard care. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Current primary outcome measure as of 16/10/2024: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 16/10/2024: |
| Completion date | 15/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 722 |
| Key inclusion criteria | 1. At least one year since diagnosed with type 2 diabetes 2. Aged >35 and <70 years 3. Current diabetes self-management education is insufficient |
| Key exclusion criteria | 1. Objection against participation from the GP 2. A psychiatric disorder which hampers participation 3. Being unable to come to the intervention location independently 4. Planning to stay abroad for a longer time during the intervention period |
| Date of first enrolment | 14/02/2022 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Bedra Horreh (b.horreh@amsterdamumc.nl). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 09/01/2025 | 20/01/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/01/2025: Publication reference added.
16/10/2024: The following changes were made to the trial record:
1. The overall end date was changed from 15/02/2025 to 15/10/2024.
2. The interventions were changed.
3. The primary outcome measure was changed.
4. The secondary outcome measures were changed.
5. The recruitment end date was changed from 30/04/2023 to 30/04/2025.
6. The intention to publish date was changed from 15/01/2025 to 30/11/2025.
18/04/2024: The intention to publish date was changed from 15/03/2024 to 15/01/2025.
30/01/2023: The recruitment end date was changed from 01/01/2023 to 30/04/2023.
29/04/2022: The sponsor contact has been updated.
22/03/2022: Trial’s existence confirmed by the Medical Ethics Review Committee of the Academic Medical Center.
