Clinical trial NCT02575599: Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice
Official title: Assessment of a Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Self-management
web-based
quantitative approach
Lead sponsor: University of Stavanger
Sponsor class: OTHER
Collaborators: name: Bergen University College
First posted: 2015-10-14
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Patient Activation Measure (PAM)
timeFrame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months
Secondary outcomes:
measure: The Health Care Climate Questionnaire (HCCQ)
timeFrame: Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months
measure: Perceived Competence for Diabetes Scale (PCDS)
timeFrame: Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months
measure: Treatment Self-Regulation (TSRQ)
timeFrame: At three time points: at baseline, 12-16 weeks later at the end of the intervention and six months after finishing the intervention.
measure: Diabetes Management Self-efficacy Scale (SE-type 2 diabetes)
timeFrame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
measure: Summary of diabetes self-care activities (SDSCA)
timeFrame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
measure: The WHO 5-item Well-Being Index (WHO-5)
timeFrame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
measure: Diabetes Distress Scale (DDS)
timeFrame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months
measure: Glycosylated haemoglobin (HbA1c)
timeFrame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Bergen University College, Inndalsveien 28, 5063 Bergen, Norway
name: Marit Graue, Professor
role: STUDY_DIRECTOR
References:
citation: Karlsen B, Oftedal B, Stangeland Lie S, Rokne B, Peyrot M, Zoffmann V, Graue M. Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol. BMJ Open. 2016 Dec 13;6(12):e013026. doi: 10.1136/bmjopen-2016-013026.