Type 2 DiabetesDiaWebNCT02575599
Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice
A study testing Guided self-determination programme (GSD) in people with Type 2 Diabetes, run by University of Stavanger.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Guided self-determination programme (GSD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes of duration ≥ 3 months
- Ability to communicate in Norwegian
- Access to the internet and bank ID
Who cannot join
- Patients with cognitive impairment
- Patients with severe co-morbidity
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Guided self-determination programme (GSD)
- Keywords
- Self-management, web-based, quantitative approach
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided self-determination programme (GSD)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counselling | Active comparator | 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. Receives: Behavioral: Guided self-determination programme (GSD) |
| Regular consultation | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The Patient Activation Measure (PAM)
Measured: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months
Secondary outcomes (8)
The Health Care Climate Questionnaire (HCCQ)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stavanger
- Sponsor type
- University, hospital or other
- Collaborators
- Bergen University College
- Responsible party
- Sponsor
- Investigators
- Marit Graue, Professor, Study director, Bergen University College, Inndalsveien 28, 5063 Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575599
- Sponsor's protocol ID
- DIW 221065
- Acronym
- DiaWeb
- Status last verified
- Nov 2016
- First submitted
- 9 Oct 2015
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27965253
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice
- ClinicalTrials.gov ID
- NCT02575599
- Acronym / sponsor ID
- DiaWeb / DIW 221065
- Conditions
- Type 2 Diabetes
- Keywords
- Self-management, web-based, quantitative approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- University of StavangerUniversity, hospital or other
- Collaborators
- Bergen University College
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counselling | Active comparator | Behavioral: Guided self-determination programme (GSD)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. |
| Regular consultation | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes of duration ≥ 3 months
- Ability to communicate in Norwegian
- Access to the internet and bank ID
Key exclusion criteria (2 listed)
- Patients with cognitive impairment
- Patients with severe co-morbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Lifestyle counselling |
Primary outcome
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
8 secondary outcomes
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
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
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.
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Derived from this study: PubMed 27965253Karlsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marit Graue, Professor study director
Bergen University College, Inndalsveien 28, 5063 Bergen, Norway
Questions about this trial
What is this clinical trial studying?
A study testing Guided self-determination programme (GSD) in people with Type 2 Diabetes, run by University of Stavanger.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bjørg Oftedal, Ph.D (+47 51834163, bjorg.oftedal@uis.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02575599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017; AzTrials last refreshed its copy on 27 Oct 2026.