Patient Education in NorthTrondelag Hospital Trust - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology The Royal Norwegian Ministry of Health
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00326222

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 III

MedlinePlus related topics: Diabetes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Patient Education in NorthTrondelag Hospital Trust - Interventions, Effects and Patient Experience

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 ]

Estimated Enrollment:	140
Study Start Date:	May 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lifestyle counseling	Behavioral: Lifestyle counseling Self-management group education
2: No Intervention Usual care

Detailed Description:

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

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326222

Locations

Norway, Nord-Trondelag
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:	NTNU/Helse Nord-Trondelag HF ( Lisbeth Ø. Rygg )
Study ID Numbers:	PASOPP1
Study First Received:	May 15, 2006
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00326222 History of Changes
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

Study placed in the following topic categories:

Diabetes Mellitus
Quality of Life

ClinicalTrials.gov processed this record on May 07, 2009