Patient Education in NorthTrondelag Hospital Trust
This study has been completed.
Sponsor:
Norwegian University of Science and Technology
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
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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
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 June 18, 2013