Guided Self-determination - Promoting Self-management in Type 1 Diabetes (GSD)

September 9, 2015 updated by: Haukeland University Hospital

Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.

Background: 50% of people with diabetes are living with too high blood sugars and increased risk of diabetes related complications together with poor quality of life. The need to improve diabetes care by better enabling patients to utilise their individual and local resources to self-manage the condition is widely recognized, yet there is a lack of access to evidence-based patient-centred healthcare interventions. At present the individual patient's judgement of own concrete situation mostly remains unexplored and insufficiently used in decision-making causing that problems perceived by the patient in living with the illness remain unrecognised and insufficiently resolved.

Aim and Methods: Guided self-determination (GSD) is an educational method developed to promote patient autonomy, participation, skills building and intrinsic motivation. In this evidence-based group-intervention the main objective is to implement and evaluate GSD through a randomised controlled trial. GSD methods will be performed seven times for the intervention group. The control group will receive traditional out-patient consultations - 'care as usual' Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective in preventing late complications and enhanced psychosocial health. GSD is presumably an intervention providing psychosocial support applicable in busy clinical practice.

An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College, and Bergen University to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Helse Vest HF, Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diabetes type one, HbA1c >= 8%

Exclusion Criteria:

Pregnancy, decreased cognitive function and/or serious mental health disturbances, language barriers to the Norwegian language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counselling
Behavioral: Guided self-determination
Group counselling
Experimental: No intervention
Care as usual
Behavioral: Guided self-determination
Group counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: 0, 9 and 18 months
0, 9 and 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Who 5
Time Frame: 0, 9 and 18 months
0, 9 and 18 months
TSRQ scales
Time Frame: 0, 9 and 18 months
0, 9 and 18 months
PAID scales
Time Frame: 0, 9 and 18 months
0, 9 and 18 months
Rosenberg's self-esteem scale
Time Frame: 0, 9 and 18 months
0, 9 and 18 months
PCD scales
Time Frame: 0, 9 and 18 months
0, 9 and 18 months
HCCQ scales
Time Frame: 0, 9 and 18 months
0, 9 and 18 months
DDS scales
Time Frame: 0, 9 and 18 months
0, 9 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Marit Graue, RN, PhD, Bergen University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

September 10, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/1325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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