Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Guided self-determination programme (GSD)

• Registration Number: NCT02575599
• Lead Sponsor: University of Stavanger

Brief Summary

The overall aim of this study is to assess the effectiveness of a web-based Guided Self-Determination program among adults with type 2 diabetes in general practice in order to improve diabetes self-management behaviours and HbA1c through enhanced patient activation, self-care competence, and autonomy.

Detailed Description

Web-based self-management programs have the potential to support adults with type 2 diabetes in managing their disease condition. However, improving health care outcomes through self-management interventions have shown somewhat ambiguous results. Therefore, it is suggested that interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. To meet these challenges, the overall aim of this study is to assess the effectiveness of a theory-driven web-based Guided Self-Determination intervention among adults with type 2 diabetes in general practice in order to enable adults with diabetes to use their individual resources to self-manage their condition and reach treatment goals.

A complex intervention design based on the framework of UK Medical Research Council is employed as a guide for developing and evaluating the intervention.

This study consists of three phases:

1. the modelling phase adapting the original Guided Self-Determination program to adults with type 2 diabetes, using a qualitative design

2. feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and

3. evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design.

The two first phases will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effect on health care outcomes of this systematically developed intervention.

Study Timeline

• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-12
• Study First Posted: 2015-10-14
• Status Verified: 2016-11
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02
• Study Start: 2018-09-01
• Primary Completion: 2019-09-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Type 2 diabetes of duration ≥ 3 months
• Ability to communicate in Norwegian
• Access to the internet and bank ID

Exclusion Criteria

• Patients with cognitive impairment
• Patients with severe co-morbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counselling	Guided self-determination programme (GSD)	Intervention group: Eighty six adults with type 2 diabetes will be recruited from the general practices where the trained nurses in Guided self-determination programme are working.

Primary Outcome Measures

Name	Time	Method
The Patient Activation Measure (PAM)	Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months

Secondary Outcome Measures

Name	Time	Method
Summary of diabetes self-care activities (SDSCA)	Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
The Health Care Climate Questionnaire (HCCQ)	Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months
Treatment Self-Regulation (TSRQ)	At three time points: at baseline, 12-16 weeks later at the end of the intervention and six months after finishing the intervention.
Diabetes Management Self-efficacy Scale (SE-type 2 diabetes)	Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
The WHO 5-item Well-Being Index (WHO-5)	Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Diabetes Distress Scale (DDS)	Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months
Glycosylated haemoglobin (HbA1c)	Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Perceived Competence for Diabetes Scale (PCDS)	Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months