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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01317459
First received: March 11, 2011
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: Guided self-determination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Who 5 [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • TSRQ scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • PAID scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • Rosenberg's self-esteem scale [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • PCD scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • HCCQ scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • DDS scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: March 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counselling Behavioral: Guided self-determination
Group counselling
Experimental: No intervention
Care as usual
Behavioral: Guided self-determination
Group counselling

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317459

Locations
Norway
Helse Vest HF, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Marit Graue, RN, PhD Bergen University College
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01317459     History of Changes
Other Study ID Numbers: 2010/1325
Study First Received: March 11, 2011
Last Updated: September 24, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Self management
Diabetes type one
Empowerment
Intrinsic motivation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014