- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00326222
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
-
-
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
|
Self-management group education
Other Names:
|
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.
Collaborators
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.
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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