Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice (DiaWeb)
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guided self-determination programme (GSD)
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Self-management, web-based, quantitative approach
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lifestyle counselling
Regular consultation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The Patient Activation Measure (PAM)
Secondary Outcome Measures
The Health Care Climate Questionnaire (HCCQ)
Perceived Competence for Diabetes Scale (PCDS)
Treatment Self-Regulation (TSRQ)
Diabetes Management Self-efficacy Scale (SE-type 2 diabetes)
Summary of diabetes self-care activities (SDSCA)
The WHO 5-item Well-Being Index (WHO-5)
Diabetes Distress Scale (DDS)
Glycosylated haemoglobin (HbA1c)
Full Information
NCT ID
NCT02575599
First Posted
October 9, 2015
Last Updated
June 1, 2017
Sponsor
University of Stavanger
Collaborators
Bergen University College
1. Study Identification
Unique Protocol Identification Number
NCT02575599
Brief Title
Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice
Acronym
DiaWeb
Official Title
Assessment of a Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Stavanger
Collaborators
Bergen University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
the modelling phase adapting the original Guided Self-Determination program to adults with type 2 diabetes, using a qualitative design
feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Self-management, web-based, quantitative approach
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counselling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Regular consultation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Guided self-determination programme (GSD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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.
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bjørg Oftedal, Ph.D
Phone
+47 51834163
Email
bjorg.oftedal@uis.no
First Name & Middle Initial & Last Name or Official Title & Degree
Bjørg Karlsen, Professor
Phone
+47 51834168
Email
bjorg.karlsen@uis.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marit Graue, Professor
Organizational Affiliation
Bergen University College, Inndalsveien 28, 5063 Bergen, Norway
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
27965253
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.
Results Reference
derived
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Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice
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