search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


DISC-studie.


- candidate number6036
- NTR NumberNTR1886
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jun-2009
- Secondary IDs76500003 Zonmw
- Public TitleDISC-studie.
- Scientific TitleDISC study (Diabetes In Social Context). Evaluation of a social network intervention for type 2 diabetics with a low socioeconomic status.
- ACRONYMDISC-studie
- hypothesisA 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) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Diagnosed with type 2 diabetes;
2. One year under treatment for diabetes;
3. Older than 30 years;
4. Living in a deprived neighbourhood.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-okt-2009
- planned closingdate1-okt-2011
- Target number of participants256
- InterventionsPowerful 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 outcomeThe primary outcome measure is HbA1c at 16 months.
- Secondary outcomeSecundary 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).
- TimepointsMeasurements will take place at baseline, 3, 10 and 16 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Charlotte Vissenberg
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Karien Stronks
- Sponsor/Initiator Academic Medical Centre (AMC), Dept of Social Medicine
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground:
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.

Methods:
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.

Conclusion:
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)
- RECORD29-jun-2009 - 6-feb-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl