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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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BMC Primary Care
Published in: BMC Primary Care 1/2007

Open Access 01-12-2007 | Study protocol

Changing illness perceptions in patients with poorly controlled type 2 diabetes, a randomised controlled trial of a family-based intervention: protocol and pilot study

Authors: Karen M Keogh, Patricia White, Susan M Smith, Sinead McGilloway, Tom O'Dowd, James Gibney

Published in: BMC Primary Care | Issue 1/2007

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Abstract

Background

This paper presents the pilot study and protocol for a randomised controlled trial to test the effectiveness of a psychological, family-based intervention to improve outcomes in those with poorly controlled type 2 diabetes. The intervention has been designed to change the illness perceptions of patients with poorly controlled type 2 diabetes, and their family members. It is a complex psychological intervention, developed from the Self-Regulatory Model of Illness Behaviour. The important influence the family context can have in psychological interventions and diabetes management is also recognised, by the inclusion of patients' family members.

Methods/design

We aim to recruit 122 patients with persistently poorly controlled diabetes. Patients are deemed to have persistent poor control when at least two out of their last three HbA1c readings are 8.0% or over. Patients nominate a family member to participate with them, and this patient/family member dyad is randomly allocated to either the intervention or control group. Participants in the control group receive their usual care. Participants in the intervention group participate, with their family members, in three intervention sessions. Sessions one and two are delivered in the participant's home by a health psychologist. Session one takes place approximately one week after session two, with the third session, a follow-up telephone call, one week later. The intervention is based upon clarifying the illness perceptions of both the patient and the family member, examining how they influence self-management behaviours, improving the degree of similarity of patient and family member perceptions in a positive direction and developing personalized action plans to improve diabetes management.

Discussion

This study is the first of its kind to incorporate the evidence from illness perceptions research into developing and applying an intervention for people with poorly controlled diabetes and their families. This study also acknowledges the important role of family members in effective diabetes care.

Trial registration

ISRCTN62219234
Appendix
Available only for authorised users
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Metadata
Title
Changing illness perceptions in patients with poorly controlled type 2 diabetes, a randomised controlled trial of a family-based intervention: protocol and pilot study
Authors
Karen M Keogh
Patricia White
Susan M Smith
Sinead McGilloway
Tom O'Dowd
James Gibney
Publication date
01-12-2007
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2007
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/1471-2296-8-36

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