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

February 28, 2017 updated by: Norwegian University of Science and Technology

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

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

  • Norway
    • Møre og Romsdal County
      • Surnadal, Møre og Romsdal County, Norway, 6650
        • Surnadal Municipality
    • Møre og Romsdal county
      • Sunndal, Møre og Romsdal county, Norway, 6600
        • Sunndal Municipality
    • Sør - Trøndelag
      • Klaebu, Sør - Trøndelag, Norway, 7540
        • Klæbu Municipality
    • Sør Trøndelag County
      • Trondheim, Sør Trøndelag County, Norway, 7000
        • Trondheim Municipality
    • Sør-Trøndelag County
      • Hitra, Sør-Trøndelag County, Norway, 7240
        • Hitra Municipality

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Sustainability of the physiological effects of muscular training (6 Minutes Walk)
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

The Research Council of Norway

Investigators

  • Study Director: Helge Garåsen, 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.

General Publications

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 (Actual)

September 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 5, 2009

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 420082351

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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