NCT00326222

Brief Summary

The purpose of this randomised open study is to examine the effect of self-management program for diabetes patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2006

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

May 15, 2006

Last Update Submit

July 18, 2016

Conditions

Diabetes Mellitus

Keywords

Patient Education as a TopicSelf-Management ProgramHealth promotionSelf EfficacyQuality of life

Outcome Measures

Primary Outcomes (2)

  • HbA1c

    Baseline, 6, and 12 mds

  • PAM - Patient activation measure

    Baseline, 6, and 12 mds

Secondary Outcomes (13)

  • SF36

    Baseline, 6, and 12 mds

  • EQ 5D-VAS scale

    Baseline, 6, and 12 mds

  • Hunt diabetes

    Baseline, 6, and 12 mds

  • WHO-DTSQ

    Baseline, 6, and 12 mds

  • Knowledge of diabetes

    Baseline, 6, and 12 mds

  • +8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Lifestyle counseling

Behavioral: Lifestyle counseling

2

NO INTERVENTION

Usual care

Interventions

Lifestyle counselingBEHAVIORAL

Self-management group education

Also known as: Self-management
1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with ICPC-2, code T89 - diabetes dependent on insulin and T90 diabetes not dependent on insulin

You may not qualify if:

  • Diagnosed with ICPC-2, code T89 - diabetes mellitus juvenile and diabetes I
  • Attended self-management program previous 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nord-Trondelag Hospital Trust

Levanger, Nord-Trondelag, 7600, Norway

Location

Related Publications (1)

  • Rygg LO, Rise MB, Gronning K, Steinsbekk A. Efficacy of ongoing group based diabetes self-management education for patients with type 2 diabetes mellitus. A randomised controlled trial. Patient Educ Couns. 2012 Jan;86(1):98-105. doi: 10.1016/j.pec.2011.04.008. Epub 2011 May 17.

    PMID: 21592715RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Aslak Steinsbekk, PhD

    Norwegian University of Science and Technology, Trondheim, Norway

    PRINCIPAL INVESTIGATOR

  • Lisbeth O Rygg, Master

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 16, 2006

Study Start

May 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

NO(1)