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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
University of Stavanger
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 9, 2015
    Last Updated
    June 1, 2017
    Sponsor
    University of Stavanger
    Collaborators
    Bergen University College
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    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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