Clinical trial NCT00989456: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2009-10-05
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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

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 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

Primary outcomes:
measure: Health related quality of life
timeFrame: One year
Secondary outcomes:
measure: Sustainability of the physiological effects of muscular training (6 Minutes Walk)
timeFrame: One year
Other outcomes:
Locations:
city: Sunndal
country: Norway
facility: Sunndal Municipality
state: Møre og Romsdal county
city: Surnadal
country: Norway
facility: Surnadal municipality
state: Møre og Romsdal County
city: Klaebu
country: Norway
facility: Klæbu Municipality
state: Sør - Trøndelag
city: Trondheim
country: Norway
facility: Trondheim Municipality
state: Sør Trøndelag County
city: Hitra
country: Norway
facility: Hitra Municipality
state: Sør-Trøndelag County
Study officials:
affiliation: Norwegian University of Science and Technology
name: Helge Garåsen
role: STUDY_DIRECTOR
References:
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.