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
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: 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 August 21, 2014