Chronic Obstructive Pulmonary DiseaseNCT00989456
Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise
A study testing Self management education programme and exercise only in people with Chronic Obstructive Pulmonary Disease and Heart Failure, run by Norwegian University of Science and Technology at 5 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Heart Failure, Stroke
- What is being tested?
- Self management education programme and exercise only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesNorway
- Study dates
- Sep 2009to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Speaking and language problems or other substantial communication problems
- Unstable medical or social situation
- Participation in another science study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Hitra Municipality
Hitra, Sør-Trøndelag County, 7240
Klæbu Municipality
Klæbu, Sør - Trøndelag, 7540
Sunndal Municipality
Sunndal, Møre Og Romsdal County, 6600
Surnadal municipality
Surnadal, Møre Og Romsdal County, 6650
Trondheim Municipality
Trondheim, Sør Trøndelag County, 7000
About this study
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.
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:
- improve quality of life, physical functioning, coping in everyday-life
- 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.
- improve patient satisfaction and health care providers satisfaction
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Heart Failure, Stroke
- Being tested
- Self management education programme, exercise only
- Keywords
- chronic obstructive pulmonary disease, Heart failure, Stroke, quality of life, self management education, physical exercise, primary health care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self management education programmeBehavioural
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 onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| exercise and education | Experimental | Supervised physical exercise in groups, plus a self management education programme (patient education). Receives: Behavioral: Self management education programme |
| exercise only | Active comparator | Supervised physical exercise in groups. Receives: Behavioral: exercise only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Measured: One year
Secondary outcomes (1)
Sustainability of the physiological effects of muscular training (6 Minutes Walk)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Helge Garåsen, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989456
- Sponsor's protocol ID
- 420082351
- Status last verified
- Feb 2017
- First submitted
- 30 Sep 2009
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25380808
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00989456
- Acronym / sponsor ID
- 420082351
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Sep 2009 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- improve quality of life, physical functioning, coping in everyday-life
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise and education | Experimental | Behavioral: Self management education programmeSupervised physical exercise in groups, plus a self management education programme (patient education). |
| exercise only | Active comparator | Behavioral: exercise onlySupervised physical exercise in groups. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Speaking and language problems or other substantial communication problems
- Unstable medical or social situation
- Participation in another science study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self management education programmeThe 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. | Behavioural | exercise and education |
| exercise only6 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. | Behavioural | exercise only |
Primary outcome
Health related quality of life
Time frame: One year
1 secondary outcome
Sustainability of the physiological effects of muscular training (6 Minutes Walk)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Background: PubMed 25380808Solberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge Garåsen study director
Norwegian University of Science and Technology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self management education programme and exercise only in people with Chronic Obstructive Pulmonary Disease and Heart Failure, run by Norwegian University of Science and Technology at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.