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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02575599
Acronym
DiaWeb
Enrollment
172
Registered
2015-10-14
Start date
2018-09-01
Completion date
2020-01-01
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Self-management, web-based, quantitative approach

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: 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.

Interventions

BEHAVIORALGuided 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.

Sponsors

Bergen University College
CollaboratorOTHER
University of Stavanger
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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
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.
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
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
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
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
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
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

Contacts

Primary ContactBjørg Oftedal, Ph.D
bjorg.oftedal@uis.no+47 51834163
Backup ContactBjørg Karlsen, Professor
bjorg.karlsen@uis.no+47 51834168

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026