Patient Education in NorthTrondelag Hospital Trust

July 18, 2016 updated by: Norwegian University of Science and Technology

Patient Education in NorthTrondelag Hospital Trust - Interventions, Effects and Patient Experience

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Nord-Trondelag
      • Levanger, Nord-Trondelag, Norway, 7600
        • Nord-Trondelag Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Usual care
Experimental: 1
Lifestyle counseling
Behavioral: Lifestyle counseling
Self-management group education
Other Names:
  • Self-management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: Baseline, 6, and 12 mds
Baseline, 6, and 12 mds
PAM - Patient activation measure
Time Frame: Baseline, 6, and 12 mds
Baseline, 6, and 12 mds

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Helse Nord-Trøndelag HF

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 16, 2006

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PASOPP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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