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

Type 2 Diabetes Clinical Trial

— DiaWeb  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02575599
• Other study ID #: DIW 221065
• Status: Not yet recruiting
• Phase: N/A
• First received: October 9, 2015
• Last updated: June 1, 2017
• Start date: September 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2016
• Source: University of Stavanger
• Contact: Bjørg Oftedal, Ph.D
• Phone: +47 51834163
• Email: bjorg.oftedal[@]uis.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 172
• Est. completion date: January 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Guided self-determination programme (GSD)
The GSD intervention consist of four e-consultations with structured reflection sheets. Reflection sheets are intended to increase patients' ability to express their views and prepare them for active participation in the care process. Through the web-based platform, the subsequent four e-consultations will allow for communication between patients and nurses. The platform allows the participants to fill in the reflection sheets using their own words and drawings to express their own experiences with self-management as well as to formulate behavioral goals and plans to achieve their goals. It also permits feedback from the nurses on these reflections sheets via secure emails. Each person will be able to access the web-based program from his or her own computers or other electronic devices.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Stavanger	Bergen University College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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