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

June 1, 2017 updated by: University of Stavanger

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lifestyle counselling
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.
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.
No Intervention: Regular consultation
Control group: Eighty six adults with type 2 diabetes will be recruited from general practices with employed registered nurses without the Guided self-determination training.

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Time Frame
The Health Care Climate Questionnaire (HCCQ)
Time Frame: Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months
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)
Time Frame: Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months
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)
Time Frame: At three time points: at baseline, 12-16 weeks later at the end of the intervention and six months after finishing the intervention.
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)
Time Frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Summary of diabetes self-care activities (SDSCA)
Time Frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
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)
Time Frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
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)
Time Frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months
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)
Time Frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Stavanger

Collaborators

Bergen University College

Investigators

  • Study Director: Marit Graue, Professor, Bergen University College, Inndalsveien 28, 5063 Bergen, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 12, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIW 221065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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