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

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989456
• Other study ID #: 420082351
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: February 28, 2017
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: February 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Hitra Municipality	Hitra	Sør-Trøndelag County
Norway	Klæbu Municipality	Klaebu	Sør - Trøndelag
Norway	Sunndal Municipality	Sunndal	Møre og Romsdal county
Norway	Surnadal municipality	Surnadal	Møre og Romsdal County
Norway	Trondheim Municipality	Trondheim	Sør Trøndelag County

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Solberg HS, Steinsbekk A, Solbjør M, Granbo R, Garåsen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life		One year
Secondary	Sustainability of the physiological effects of muscular training (6 Minutes Walk)		One year