Abstract
BackgroundThe present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus (T2DM) patients (one to three years post-diagnosis) and their partners. The course aims to support T2DM patients and their partners in successfully integrating diabetes care into their daily lives and hereby enhance self-management and diabetes-specific health-related quality of life. The content of the course is based on the Common-Sense Model of Self-Regulation (CSM). Furthermore, principles from the Social Cognitive Theory (SCT) and social support theories are integrated.Methods/DesignWe aim to recruit 160 recently diagnosed T2DM patients and their partners from general practices in six different regions in the Netherlands. Patients need to be diagnosed with T2DM for one to three years and have to experience some degree of diabetes-related difficulties, as measured with a three-item screener. Participating patients and their partners are randomly allocated to the intervention or control condition. Participants in the intervention condition receive three monthly group sessions and a booster session three months later. Participants in the control condition receive a single information meeting. Data will be collected at baseline (T0), directly after the programme (T1) and six months post-programme (T2), including: self-management, diabetes-specific health-related quality of life, illness perceptions, attitudes, social support and empowerment. A three-level multilevel model will be used to compare change-scores between the conditions (intervention/control) on each outcome.DiscussionOur study will be the first to determine whether a group-based support programme based on the CSM is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients. The important role of patients’ partners in effective diabetes care is also acknowledged in the study.Trial registrationNetherlands National Trial Register (NTR) NTR3302.
Highlights
The present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus (T2DM) patients and their partners
Our study will be the first to determine whether a group-based support programme based on the Common-Sense Model of Self-Regulation (CSM) is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients
Given the importance to intervene at an early stage in T2DM and the promising results of previous studies based on the CSM, we developed the ‘Living with diabetes’ course: a group-based self-management support programme tailored to T2DM patients and their partners in the first years of living with diabetes
Summary
This article describes the design of the ‘Living with diabetes’ study: a study testing the effectiveness of a group-based self-management support programme for people known to be diagnosed with T2DM for one to three years and their partners. Participating GPs will probably represent a group more open to research and innovation and may be more motivated to improve diabetes care Their patients might already receive various educational or support programmes which may negatively impact on participation willingness. The course sessions and information meetings will be organised in accessible locations in the area of the participating patients and GPs. a practical challenge is foreseen in the group-based format of the course. We will recruit diabetes nurses and practice nurses who already have experience in leading group-based courses and extra attention will be paid on how to deal with dominant group members during the training The results of this RCT will provide valuable information on the effectiveness and feasibility of group-based self-management support programmes, focusing on illness perceptions and social support.
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