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Open Access 01-12-2014 | Study protocol

Living with diabetes: a group-based self-management support programme for T2DM patients in the early phases of illness and their partners, study protocol of a randomised controlled trial

Authors: Anne L van Puffelen, Mieke Rijken, Monique JWM Heijmans, Giel Nijpels, Guy EHM Rutten, François G Schellevis

Published in: BMC Health Services Research | Issue 1/2014

Abstract

Background

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 (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/Design

We 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.

Discussion

Our 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 registration

Netherlands National Trial Register (NTR) NTR3302.

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/14/144/prepub

Title: Living with diabetes: a group-based self-management support programme for T2DM patients in the early phases of illness and their partners, study protocol of a randomised controlled trial
Authors: Anne L van Puffelen
Mieke Rijken
Monique JWM Heijmans
Giel Nijpels
Guy EHM Rutten
François G Schellevis
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: BMC Health Services Research / Issue 1/2014
Electronic ISSN: 1472-6963
DOI: https://doi.org/10.1186/1472-6963-14-144

Keynote webinar | Spotlight on medication adherence

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Living with diabetes: a group-based self-management support programme for T2DM patients in the early phases of illness and their partners, study protocol of a randomised controlled trial

Abstract

Background

Methods/Design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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