|- candidate number||12895|
|- NTR Number||NTR3474|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jun-2012|
|- Secondary IDs||2009.70 Diabetes Fonds|
|- Public Title||Peer support for patients with type 2 diabetes.|
|- Scientific Title||Diacourse peer study: Development and evaluation of a peer support intervention for patients with type 2 diabetes.|
|- hypothesis||The overall objective of this study is to develop and evaluate the effectiveness of a peer support intervention patients with type 2 diabetes to enhance self-management behaviour and (health-related) quality of life.
The primary objective of this study is to assess the effect of peer support, in T2DM patients, on quality of life, well-being, diabetes-related distress and self-management behaviour. In addition, we will investigate the effects on changes in self-efficacy, self-esteem and experienced social support.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Selfmanagement, Quality of life, Primary care, Peer support|
|- Inclusion criteria||1. Patients diagnosed with type 2 diabetes, with a known illness duration of 4 years or more;|
2. Between the age of 50 and 70 years old.
|- Exclusion criteria||1. No sufficient understanding of the Dutch language;|
2. No sufficient mental capabilities;
3. Suffering from severe psychological or psychiatric problems.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-sep-2013|
|- Target number of participants||200|
|- Interventions||The peer support intervention consists of six monthly group sessions of 2 hours. A group will comprise 12-15 patients with type 2 diabetes and will be led by a trained peer leader. The peer leader -who knows what it is like to deal with diabetes- will be supported by a social worker to encourage patients to share their stories. The social worker will guide the peer leader and monitor the group processes.
Participants receive a handbook with information on different subjects concerning diabetes and assignments to encourage the exchange of experiences.
Participants in the control condition will be invited to a single informational meeting. During the meeting, the participants receive information on for example the latest (scientific) developments in diabetes care and research. The informational meeting will be led by diabetes researchers/diabetologists.
|- Primary outcome||1. Health-related quality of life, both generic and diabetes-specific. This will be measured as diabetes distress and well-being;|
2. Self-management behaviour.
|- Secondary outcome||1. Self-efficacy;|
3. Social support.
|- Timepoints||The baseline measurement (T0) will be conducted before the fist group-session or informational meeting. The second measurement directly after the last group-session (T1) and the last measurement will be conducted six months after the last group-session (T2). |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. Lianne Vries, de|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Giel Nijpels|
|- Sponsor/Initiator ||VU University Medical Center, EMGO-Institute|
(Source(s) of Monetary or Material Support)
|Dutch Diabetes Foundation|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||13-jun-2012 - 20-jun-2012|