Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise
Primary Purpose
Chronic Obstructive Pulmonary Disease, Heart Failure, Stroke
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Self management education programme
exercise only
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, Heart failure, Stroke, quality of life, self management education, physical exercise, primary health care
Eligibility Criteria
Inclusion Criteria:
- 45 years of age or more
- Living at home
- Capable of active participation in a group setting
- Walking distance within 550 meter in 6 minutes
- Chronic obstructive pulmonary disease (COPD) I-III
- Chronic heart disease I-III
- Stroke(0-2 on Modified Rankin Scale)
Exclusion Criteria:
- Speaking and language problems or other substantial communication problems
- Unstable medical or social situation
- Participation in another science study
Sites / Locations
- Sunndal Municipality
- Surnadal municipality
- Klæbu Municipality
- Trondheim Municipality
- Hitra Municipality
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
exercise and education
exercise only
Arm Description
Supervised physical exercise in groups, plus a self management education programme (patient education).
Supervised physical exercise in groups.
Outcomes
Primary Outcome Measures
Health related quality of life
Secondary Outcome Measures
Sustainability of the physiological effects of muscular training (6 Minutes Walk)
Full Information
NCT ID
NCT00989456
First Posted
September 30, 2009
Last Updated
February 28, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT00989456
Brief Title
Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise
Official Title
Structured Patient Education in Combination With Physical Exercise as Part of the Integrated Care to Chronically Ill Patients With Chronic Obstructive Pulmonary Disease, Heart Failure and Stroke. A Randomized Controlled Intervention Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study addresses self management and maintenance of health through evaluation of a program of patient education in combination with physical training and with a structured follow-up.
It is hypothesized that such a program will:
improve quality of life, physical functioning, coping in everyday-life
reduce hospitalization and (re-)admissions for patients with chronic disease, reduce consumption of home care services and can increase consumption of general practice and physiotherapy services in primary health care.
improve patient satisfaction and health care providers satisfaction
Detailed Description
Patients with chronically, long-lasting illness, have complex needs for treatment and care, which none of the service providers can fulfill on their own. Both patients and their relatives are in danger of experiencing severe lack of quality. Integrated care path programs are increasingly put into use. There is insufficient research-based documentation of the effect of such care paths.
The available documentation of different integrated care paths emphasizes early mobilization and discharge, rehabilitation in familiar surroundings, more effective communication and exchange of competence between the different service providers and educational self-management for patients as main elements in order to expect effect.
There are no studies that evaluate the effect of quality of life, functional skills and personal coping if group-based educational self management is combined with physical exercise and patients with different chronically illnesses participate in the same group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Heart Failure, Stroke
Keywords
chronic obstructive pulmonary disease, Heart failure, Stroke, quality of life, self management education, physical exercise, primary health care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise and education
Arm Type
Experimental
Arm Description
Supervised physical exercise in groups, plus a self management education programme (patient education).
Arm Title
exercise only
Arm Type
Active Comparator
Arm Description
Supervised physical exercise in groups.
Intervention Type
Behavioral
Intervention Name(s)
Self management education programme
Intervention Description
The structured patient educational self - management programme consists of 6 weekly sessions à 2 hours. The educational programme will take place prior to one of the two weekly training sessions.
After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care. During the last month of the intervention year educational self - management will be offered twice and focus on themes that the participants wish to refresh.
Intervention Type
Behavioral
Intervention Name(s)
exercise only
Intervention Description
6 week waiting list, followed by two weekly training sessions. After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care.
Primary Outcome Measure Information:
Title
Health related quality of life
Time Frame
One year
Secondary Outcome Measure Information:
Title
Sustainability of the physiological effects of muscular training (6 Minutes Walk)
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
45 years of age or more
Living at home
Capable of active participation in a group setting
Walking distance within 550 meter in 6 minutes
Chronic obstructive pulmonary disease (COPD) I-III
Chronic heart disease I-III
Stroke(0-2 on Modified Rankin Scale)
Exclusion Criteria:
Speaking and language problems or other substantial communication problems
Unstable medical or social situation
Participation in another science study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helge Garåsen
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Sunndal Municipality
City
Sunndal
State/Province
Møre og Romsdal county
ZIP/Postal Code
6600
Country
Norway
Facility Name
Surnadal municipality
City
Surnadal
State/Province
Møre og Romsdal County
ZIP/Postal Code
6650
Country
Norway
Facility Name
Klæbu Municipality
City
Klaebu
State/Province
Sør - Trøndelag
ZIP/Postal Code
7540
Country
Norway
Facility Name
Trondheim Municipality
City
Trondheim
State/Province
Sør Trøndelag County
ZIP/Postal Code
7000
Country
Norway
Facility Name
Hitra Municipality
City
Hitra
State/Province
Sør-Trøndelag County
ZIP/Postal Code
7240
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25380808
Citation
Solberg HS, Steinsbekk A, Solbjor M, Granbo R, Garasen H. Characteristics of a self-management support programme applicable in primary health care: a qualitative study of users' and health professionals' perceptions. BMC Health Serv Res. 2014 Nov 8;14:562. doi: 10.1186/s12913-014-0562-9.
Results Reference
background
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Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise
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