Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00989456
First received: September 30, 2009
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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:

  1. improve quality of life, physical functioning, coping in everyday-life
  2. 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.
  3. improve patient satisfaction and health care providers satisfaction

Condition Intervention
Chronic Obstructive Pulmonary Disease
Heart Failure
Stroke
Behavioral: Self management education programme
Behavioral: exercise only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustainability of the physiological effects of muscular training (6 Minutes Walk) [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2009
Study Completion Date: April 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise and education
Supervised physical exercise in groups, plus a self management education programme (patient education).
Behavioral: Self management education programme

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.

Active Comparator: exercise only
Supervised physical exercise in groups.
Behavioral: exercise only
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989456

Locations
Norway
Sunndal Municipality
Sunndal, Møre og Romsdal county, Norway, 6600
Surnadal municipality
Surnadal, Møre og Romsdal County, Norway, 6650
Klæbu Municipality
Klaebu, Sør - Trøndelag, Norway, 7540
Trondheim Municipality
Trondheim, Sør Trøndelag County, Norway, 7000
Hitra Municipality
Hitra, Sør-Trøndelag County, Norway, 7240
Sponsors and Collaborators
Norwegian University of Science and Technology
The Research Council of Norway
Investigators
Study Director: Helge Garåsen Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00989456     History of Changes
Other Study ID Numbers: 420082351
Study First Received: September 30, 2009
Last Updated: April 9, 2013
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
chronic obstructive pulmonary disease
Heart failure
Stroke
quality of life
self management education
physical exercise
primary health care

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Nervous System Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014