NCT00989456

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

September 30, 2009

Last Update Submit

February 28, 2017

Conditions

Keywords

chronic obstructive pulmonary diseaseHeart failureStrokequality of lifeself management educationphysical exerciseprimary health care

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life

    One year

Secondary Outcomes (1)

  • Sustainability of the physiological effects of muscular training (6 Minutes Walk)

    One year

Study Arms (2)

exercise and education

EXPERIMENTAL

Supervised physical exercise in groups, plus a self management education programme (patient education).

Behavioral: Self management education programme

exercise only

ACTIVE COMPARATOR

Supervised physical exercise in groups.

Behavioral: exercise only

Interventions

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 and education
exercise onlyBEHAVIORAL

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.

exercise only

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Speaking and language problems or other substantial communication problems
  • Unstable medical or social situation
  • Participation in another science study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sunndal Municipality

Sunndal, Møre Og Romsdal County, 6600, Norway

Location

Surnadal municipality

Surnadal, Møre Og Romsdal County, 6650, Norway

Location

Klæbu Municipality

Klæbu, Sør - Trøndelag, 7540, Norway

Location

Trondheim Municipality

Trondheim, Sør Trøndelag County, 7000, Norway

Location

Hitra Municipality

Hitra, Sør-Trøndelag County, 7240, Norway

Location

Related Publications (1)

  • 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.

    PMID: 25380808BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart FailureStrokeMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesBehavior

Study Officials

  • Helge Garåsen

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 5, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2011

Study Completion

April 1, 2013

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations