|- candidate number||11175|
|- NTR Number||NTR3302|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-feb-2012|
|- Secondary IDs||2009.70 Diabetes Fonds|
|- Public Title||Group-based support for type 2 diabetes patients (1 - 3 years post-diagnosis) and partners. |
|- Scientific Title||Living with diabetes: Development and evaluation of a family-based intervention to strengthen adaptive illness perceptions in patients with type 2 diabetes (1 - 3 years post-diagnosis) and their partners. |
|- hypothesis||The overall objective of this study is to develop and evaluate the effectiveness of a group-based intervention aimed at helping patients with type 2 diabetes (1 - 3 post-diagnosis) and their partners incorporate the illness and treatment into their daily lives and, consequently, enhance self-management and (health-related) quality of life.
Primary objective: To evaluate the effectiveness of a group-based intervention, based on the Common-Sense Model of Self-Regulation (CSM), on (health-related) quality of life and self-management behaviours in patients with type 2 diabetes (1 - 3 years post-diagnosis).
Secondary objective: To evaluate the effectiveness of the intervention on illness perceptions, spousal support and patient activation.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Primary care, Selfmanagement|
|- Inclusion criteria||1. Patients diagnosed with type 2 diabetes, with a known illness duration of 1 - 3 years;|
2. Score of 1 or more on a screener measuring perceived burden of diabetes.
|- 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-mrt-2012|
|- planned closingdate||31-jul-2013|
|- Target number of participants||200|
|- Interventions||The intervention is based on the Common-Sense Model of Self-Regulation (CSM) and social learning theories. The intervention consists of three monthly group-based sessions of 2 hours, with a follow-up meeting after three months. The groups will comprise 7 - 10 patients with type 2 diabetes and their partners and will be led by two trained diabetes nurses. Participants receive a handbook with background information and (homework) assignments.
1st meeting: Exploration of illness and treatment perceptions, with special attention to perceived control and consequences. Creating awareness on personal beliefs and how these may differ from other participants. Strengthening adaptive perceptions through the provision of information and challenging maladaptive perceptions.
2nd meeting: Creating awareness on how thoughts, feelings and behaviours are related. Discussing difficulties in living with diabetes and exploring ways on how to deal with challenging situations. Learning how to translate challenges into actions. Developing an action plan.
3rd meeting: Evaluation of the action plans; to what extent where the goals reached and what barriers are perceived/encountered? Discussing (un)helpful supportive interactions and explore personal support needs. Including partner support in the next action plan.
Follow-up meeting: Evaluation of (changes in) self-management behaviours and promoting/impeding factors.
Participants in the control condition will be invited to a single informational meeting. During the meeting, the participants receive information on the latest scientific developments in diabetes care and research. The informational meeting will be led by researchers/clinicians in diabetes care.
|- 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. Illness perceptions;|
2. Spousal support;
3. Patient activation.
|- 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|
|- CONTACT FOR PUBLIC QUERIES||MSc. A.L. Puffelen, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.M. Rijken|
|- Sponsor/Initiator ||NIVEL|
(Source(s) of Monetary or Material Support)
|Dutch Diabetes Foundation|
|- Brief summary||Rationale: |
Self-management is an important part of diabetes care. Nonetheless, many patients perceive the daily care for diabetes to be complex and demanding, and have difficulties incorporating diabetes management within the context of their other goals, health issues, and relationship with their partner. Consequently, (health-related) quality of life can be decreased. Psychological factors, such as illness perceptions and social support, are proven to be associated with self-management and quality of life in chronic illness. Therefore, we developed an intervention to enhance (congruence of) adaptive illness perceptions and supportive patient-partner interactions. The intervention aims at patients who were diagnosed with type 2 diabetes 1 - 3 years ago, since we hypothesize that illness perceptions and adaptation to living with the illness will be most amendable to change during the first years after diagnosis.
To develop and evaluate the effectiveness of a group-based intervention aimed at helping patients with type 2 diabetes (1 - 3 post-diagnosis) and their partner incorporate the illness and treatment into their daily lives and, consequently, enhance self-management and (health-related) quality of life.
Randomised controlled trial. Patients and their partners will be randomly referred to the intervention (n = 100) or control condition (n = 100). Participants in the intervention condition will be offered three monthly group-based sessions, with a follow-up session after three months. Participants in the control condition will be offered a single informational meeting.
Patients with diabetes type 2 (1 - 3 years post-diagnosis) who are registered in participating general practices in the regions of West-Friesland, Utrecht and Breda.
The intervention condition consists of three 2-hour group-based meetings (and one follow-up meeting after three months) of 7 - 10 patients and their partners, led by two diabetes nurses. The intervention is based on the CSM and focuses on (congruence of) illness perceptions, action plans and social support.
Main study parameters:
Primary: (Health-related) quality of life, self-management.
Secondary: Illness perceptions, spousal support, patient activation.
|- Main changes (audit trail)|
|- RECORD||21-feb-2012 - 3-mrt-2012|