NCT02575599

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
172

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2018

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

First Submitted

Initial submission to the registry

October 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
2.9 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 2, 2017

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 9, 2015

Last Update Submit

June 1, 2017

Conditions

Type 2 Diabetes

Keywords

Self-managementweb-basedquantitative approach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Lifestyle counselling

ACTIVE COMPARATOR

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.

Behavioral: Guided self-determination programme (GSD)

Regular consultation

NO INTERVENTION

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.

Interventions

Guided self-determination programme (GSD)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.

Lifestyle counselling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes of duration ≥ 3 months
  • Ability to communicate in Norwegian
  • Access to the internet and bank ID

You may not qualify if:

  • Patients with cognitive impairment
  • Patients with severe co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27965253DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Marit Graue, Professor

    Bergen University College, Inndalsveien 28, 5063 Bergen, Norway

    STUDY DIRECTOR

Central Study Contacts

Bjørg Oftedal, Ph.D

CONTACT

+47 51834163bjorg.oftedal@uis.no

Bjørg Karlsen, Professor

CONTACT

+47 51834168bjorg.karlsen@uis.no

Study Design

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

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 14, 2015

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

January 1, 2020

Last Updated

June 2, 2017

Record last verified: 2016-11