|- candidate number||6036|
|- NTR Number||NTR1886|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-jun-2009|
|- Secondary IDs||76500003 Zonmw|
|- Public Title||DISC-studie.|
|- Scientific Title||DISC study (Diabetes In Social Context). Evaluation of a social network intervention for type 2 diabetics with a low socioeconomic status.
|- hypothesis||A social network intervention (‘Powerful Together with Diabetes’) will enable diabetic patients in lower socioeconomic groups to effectively manage their type 2 diabetes and optimize their metabolic control, health related outcomes, diabetes related behaviour and psycho-social outcomes.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||1. Diagnosed with type 2 diabetes;|
2. One year under treatment for diabetes;
3. Older than 30 years;
4. Living in a deprived neighbourhood.
|- Exclusion criteria||1. Their General Practitioner objects against paticipation;|
2. The patient has severe psychiatric disorders;
3. The patient can't come to the location of the intervention independently;
4. The patient is planning to stay abroad for a longer period of time;
5. The patient is participating in other interventions aimed at improving his/her lifestyle.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-okt-2009|
|- planned closingdate||1-okt-2011|
|- Target number of participants||256|
|- Interventions||Powerful Together with Diabetes is a culturally sensitive social network intervention specifically targeted to ethnic Dutch, Moroccan, Turkish, and Surinamese diabetic patients in lower socioeconomic groups. For ten months, patients will participate in peer support groups in which they will share experiences, support each other in maintaining healthy lifestyles, and learn skills to resist social pressure. At the same time, their significant others will also receive an intervention, aimed at maximizing support for and minimizing the negative social influences on diabetes self-management. Know your Sugar is a six-week group intervention that does not focus on the participants’ social environments.|
|- Primary outcome||The primary outcome measure is HbA1c at 16 months. |
|- Secondary outcome||Secundary outcome measures are health related outcome measures (lipid profile, blood pressure, BMI, weight, waist circumstance, blood glucose values), diabetes related behaviour (nutrition, physical activity, medication adherence) and psycho social outcomes (quality of life, depression). |
|- Timepoints||Measurements will take place at baseline, 3, 10 and 16 months. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. Charlotte Vissenberg|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Karien Stronks|
|- Sponsor/Initiator ||Academic Medical Centre (AMC), Dept of Social Medicine|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background:|
Compared to those in higher socioeconomic groups, diabetic patients in lower socioeconomic groups have less favourable metabolic control and experience more diabetes-related complications. They encounter specific barriers that hinder optimal diabetes self-management, including a lack of social support and other psychosocial mechanisms in their immediate social environments. Powerful Together with Diabetes is a culturally sensitive social network intervention specifically targeted to ethnic Dutch, Moroccan, Turkish, and Surinamese diabetic patients in lower socioeconomic groups. For ten months, patients will participate in peer support groups in which they will share experiences, support each other in maintaining healthy lifestyles, and learn skills to resist social pressure. At the same time, their significant others will also receive an intervention, aimed at maximizing support for and minimizing the negative social influences on diabetes self-management.
This study aims to test the effectiveness of Powerful Together with Diabetes. We will use a quasi-experimental design with an intervention group (Group 1) and two comparison groups (Groups 2 and 3), N=128 in each group. Group 1 will receive Powerful Together with Diabetes. Group 2 will receive Know your Sugar, a six-week group intervention that does not focus on the participants’ social environments. Group 3 will receive standard care only. Assessment: participants in Groups 1 and 2 will be interviewed and physically examined at baseline, 3, 10, and 16 months. We will compare their haemoglobin A1C levels with the haemoglobin A1C levels of Group 3. Main outcome measures: haemoglobin A1C, diabetes-related quality of life, diabetes self-management, health-related, and intermediate outcome measures. We will conduct a process evaluation and a qualitative study to gain more insights into the intervention fidelity, feasibility, and changes in the psychosocial mechanism in the participants’ immediate social environments.
With this study, we will assess the feasibility and effectiveness of a culturally sensitive social network intervention for lower socioeconomic groups. Furthermore, we will study how to enable these patients to optimally manage their diabetes.
|- Main changes (audit trail)|
|- RECORD||29-jun-2009 - 6-feb-2012|