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

NCT ID: NCT02575599

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-01-01

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Guided self-determination programme (GSD)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bergen University College

OTHER

Sponsor Role: collaborator

University of Stavanger

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marit Graue, Professor

Role: STUDY_DIRECTOR

Bergen University College, Inndalsveien 28, 5063 Bergen, Norway

Central Contacts

Bjørg Oftedal, Ph.D

Role: CONTACT

bjorg.oftedal@uis.no

+47 51834163

Bjørg Karlsen, Professor

Role: CONTACT

bjorg.karlsen@uis.no

+47 51834168

References

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.

Reference Type: DERIVED

PMID: 27965253 (View on PubMed)

Other Identifiers

DIW 221065

Identifier Type: -

Identifier Source: org_study_id