Patient Education in NorthTrondelag Hospital Trust

This study has been completed.
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00326222
First received: May 15, 2006
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Diabetes
Behavioral: Lifestyle counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Patient Education in NorthTrondelag Hospital Trust - Interventions, Effects and Patient Experience

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • HbA1c [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • PAM - Patient activation measure [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF36 [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • EQ 5D-VAS scale [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • Hunt diabetes [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • WHO-DTSQ [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • Knowledge of diabetes [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • Creatinin [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • Cost/benefit [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]
  • Triglyceride [ Time Frame: Baseline, 6, and 12 mds ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: May 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lifestyle counseling
Behavioral: Lifestyle counseling
Self-management group education
Other Name: Self-management
No Intervention: 2
Usual care

Detailed Description:

The primary aim in this study is HbA1c in addition to secondary aims like quality of life and coping.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diagnosed with ICPC-2, code T89 - diabetes mellitus juvenile and diabetes I
  • Attended self-management program previous 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326222

Locations
Norway
Nord-Trondelag Hospital Trust
Levanger, Nord-Trondelag, Norway, 7600
Sponsors and Collaborators
Norwegian University of Science and Technology
The Royal Norwegian Ministry of Health
Investigators
Principal Investigator: Aslak Steinsbekk, PhD Norwegian University of Science and Technology, Trondheim, Norway
Principal Investigator: Lisbeth O Rygg, Master Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Lisbeth Ø. Rygg, NTNU/Helse Nord-Trondelag HF
ClinicalTrials.gov Identifier: NCT00326222     History of Changes
Other Study ID Numbers: PASOPP1
Study First Received: May 15, 2006
Last Updated: September 8, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Patient education
Self-Management Program
Health promotion
Self Efficacy
Quality of life
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014