NCT01317459

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

5.8 years

First QC Date

March 11, 2011

Last Update Submit

September 9, 2015

Conditions

Diabetes

Keywords

Self managementDiabetes type oneEmpowermentIntrinsic motivation

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    0, 9 and 18 months

Secondary Outcomes (7)

  • Who 5

    0, 9 and 18 months

  • TSRQ scales

    0, 9 and 18 months

  • PAID scales

    0, 9 and 18 months

  • Rosenberg's self-esteem scale

    0, 9 and 18 months

  • PCD scales

    0, 9 and 18 months

  • +2 more secondary outcomes

Study Arms (2)

Lifestyle counselling

EXPERIMENTAL
Behavioral: Guided self-determination

No intervention

EXPERIMENTAL

Care as usual

Behavioral: Guided self-determination

Interventions

Guided self-determinationBEHAVIORAL

Group counselling

Lifestyle counsellingNo intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetes type one, HbA1c \>= 8%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helse Vest HF, Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (2)

  • Mohn J, Igland J, Zoffmann V, Peyrot M, Graue M. Factors explaining variation in self-esteem among persons with type 1 diabetes and elevated HbA1c. PLoS One. 2018 Aug 10;13(8):e0201006. doi: 10.1371/journal.pone.0201006. eCollection 2018.

    PMID: 30096144DERIVED

  • Mohn J, Graue M, Assmus J, Zoffmann V, Thordarson H, Peyrot M, Rokne B. The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c >/=64 mmol/mol: a group-based randomised controlled trial. BMJ Open. 2017 Jul 3;7(6):e013295. doi: 10.1136/bmjopen-2016-013295.

    PMID: 28674125DERIVED

MeSH Terms

Conditions

Diabetes MellitusEmpowerment

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSocial BehaviorBehavior

Study Officials

  • Marit Graue, RN, PhD

    Bergen University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 17, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2021

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

NO(1)