Patient Education in NorthTrondelag Hospital Trust

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326222
• Other study ID #: PASOPP1
• Status: Completed
• Phase: N/A
• First received: May 15, 2006
• Last updated: July 18, 2016
• Start date: May 2006
• Est. completion date: November 2008

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Lifestyle counseling
Self-management group education

Locations

Country	Name	City	State
Norway	Nord-Trondelag Hospital Trust	Levanger	Nord-Trondelag

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Central Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Rygg LØ, Rise MB, Grønning K, Steinsbekk A. Efficacy of ongoing group based diabetes self-management education for patients with type 2 diabetes mellitus. A randomised controlled trial. Patient Educ Couns. 2012 Jan;86(1):98-105. doi: 10.1016/j.pec.2011.04 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		Baseline, 6, and 12 mds	No
Primary	PAM - Patient activation measure		Baseline, 6, and 12 mds	No
Secondary	SF36		Baseline, 6, and 12 mds	No
Secondary	EQ 5D-VAS scale		Baseline, 6, and 12 mds	No
Secondary	Hunt diabetes		Baseline, 6, and 12 mds	No
Secondary	WHO-DTSQ		Baseline, 6, and 12 mds	No
Secondary	Knowledge of diabetes		Baseline, 6, and 12 mds	No
Secondary	HDL-cholesterol		Baseline, 6, and 12 mds	No
Secondary	Total cholesterol		Baseline, 6, and 12 mds	No
Secondary	Creatinin		Baseline, 6, and 12 mds	No
Secondary	Blood pressure		Baseline, 6, and 12 mds	No
Secondary	Weight		Baseline, 6, and 12 mds	No
Secondary	BMI		Baseline, 6, and 12 mds	No
Secondary	Cost/benefit		Baseline, 6, and 12 mds	No
Secondary	Triglyceride		Baseline, 6, and 12 mds	No