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Patient Education in NorthTrondelag Hospital Trust

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00326222
First Posted: May 16, 2006
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Central Norway Regional Health Authority
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
The purpose of this randomised open study is to examine the effect of self-management program for diabetes patients.

Condition Intervention
Diabetes Mellitus Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • PAM - Patient activation measure [ Time Frame: Baseline, 6, and 12 mds ]

Secondary Outcome Measures:
  • SF36 [ Time Frame: Baseline, 6, and 12 mds ]
  • EQ 5D-VAS scale [ Time Frame: Baseline, 6, and 12 mds ]
  • Hunt diabetes [ Time Frame: Baseline, 6, and 12 mds ]
  • WHO-DTSQ [ Time Frame: Baseline, 6, and 12 mds ]
  • Knowledge of diabetes [ Time Frame: Baseline, 6, and 12 mds ]
  • HDL-cholesterol [ Time Frame: Baseline, 6, and 12 mds ]
  • Total cholesterol [ Time Frame: Baseline, 6, and 12 mds ]
  • Creatinin [ Time Frame: Baseline, 6, and 12 mds ]
  • Blood pressure [ Time Frame: Baseline, 6, and 12 mds ]
  • Weight [ Time Frame: Baseline, 6, and 12 mds ]
  • BMI [ Time Frame: Baseline, 6, and 12 mds ]
  • Cost/benefit [ Time Frame: Baseline, 6, and 12 mds ]
  • Triglyceride [ Time Frame: Baseline, 6, and 12 mds ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326222


Locations
Norway
Nord-Trondelag Hospital Trust
Levanger, Nord-Trondelag, Norway, 7600
Sponsors and Collaborators
Norwegian University of Science and Technology
Central Norway Regional Health Authority
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

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00326222     History of Changes
Other Study ID Numbers: PASOPP1
First Submitted: May 15, 2006
First Posted: May 16, 2006
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Norwegian University of Science and Technology:
Patient Education as a Topic
Self-Management Program
Health promotion
Self Efficacy
Quality of life

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