Study of the effects of self-treatment and an exercise program within a self-management program in outpatients with chronic obstructive pulmonary disease (COPD): the COPE II-study

ISRCTN ISRCTN81447311
DOI https://doi.org/10.1186/ISRCTN81447311
Secondary identifying numbers NTR325; Astma Fonds: 3.4.02.12; MEC:P04-13
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
21/07/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. van der Palen
Scientific

Medisch Spectrum Twente
P.O. Box 50000
Enschede
7500 KA
Netherlands

Study information

Study designRandomised active-controlled factorial trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleStudy of the effects of self-treatment and an exercise program within a self-management program in outpatients with chronic obstructive pulmonary disease (COPD): the COPE II-study
Study acronymCOPE II
Study objectivesA self-management program including self-treatment of exacerbations, leads to a reduction in the severity and duration of exacerbation compared to a similar self-management program without these self-treatment guidelines in hospital out-patients with chronic obstructive pulmonary disease (COPD) after one year and after two years. A self-management program including a COPE-active program, has an additional effect on functional exercise performance compared to a similar program without this COPE-active program in hospital out-patients with COPD after one year and after to years.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease (COPD)
InterventionThe study will be divided into two periods. During the first three-month period, smokers motivated to quit are offered an intensive smoking cessation program. In the second phase, all patients will be ordered over four groups: A1, A2, B1 and B2, according to a two by two factorial design. The division of 200 patients over the four study groups will be done with the help of a balancing program. Potential confounders such as smoking status, gender, lung function, participation in physiotherapy programs and the use of inhaled corticosteroids will be balanced over the four groups. After division, all patients will receive a self-management program (four group sessions of two hours and several phone calls made by a respiratory nurse). During the self-management program, only the patients in the groups A1 and B1 will learn to treat themselves in case of an exacerbation. This will be done with help of individual guidelines for self-treatment of exacerbations (action plans). After the last group session of the self-management program, patients in the groups A1 and B1 will be obliged to participate in an intensive physical exercise program (COPE-active) program for six months, which can be continued until a maximum of eleven months.
Intervention typeBehavioural
Primary outcome measure1. Effect of self-treatment within a self-management program: duration and severity of the exacerbations. Measured by daily diaries which are filled out by all the patients during the total length of the study.
2. Effect of an exercise program within a self-management program: Functional exercise capacity: Shuttle Walk Test
Secondary outcome measures1. Quality of life: Chronic Respiratory Questionnaire (CRQ) (Self-Administered Standarised version)
2. Health Status: Clinical COPD Questionnaire (CCQ)
3. Social Support: Social Support List (SSL-12)
4. Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
5. Self-Efficacy: Self-Efficacy list
6. Dypnoe Medical Research Council Scale
7. Lung function: FEV1, FEV1/inspired vital capacity (IVC), FEV1/forced vital capacity (FVC)
8. Percentage of Fat Free Mass: Bioelectrical Impedance Measurements
9. Utilities: Euroqol 5D + Visual Analogue Scale (VAS)
10. Activity at home: Pedometers
11. Costs: Program costs, Direct medical costs (e.g the number of hospitalisations, emergency room visits, doctor consultations, and the medication used for COPD), direct non-medical costs (e.g. travel costs), indirect costs (e.g. lost productivity including usual daily activities and time costs borne by the individual)
12. Number of patients who quitted the COPE-active program: during the first 6 months, after the 6th month
13 Adverse events: co-morbidity, social events, etc.
Overall study start date01/11/2004
Completion date01/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Key inclusion criteria1. Forced expiratory volume in one second (FEV1) between 25% and 80% of the predicted value
2. Three or more exacerbations or one hospitalisation in the two years preceding study entry
3. A signed and dated written informed consent from the subject prior to study participation
4. Patients of the outpatient clinic of the Medisch Spectrum Twente
5. Aged between 40 and 75 years
6. A clinical diagnosis of COPD as defined by the GOLD-criteria
7. Stable and well controlled COPD, at least one month before inclusion
8. Current smoker or ex-smoker
9. Able to understand, read and write Dutch
Key exclusion criteria1. Serious other disease with a low survival rate
2. Other disease which influences bronchial symptoms and/or lung function (e.g. cardiac insufficiency, sarcoïdosis)
3. Severe psychiatric illness
4. A disregulation of diabetes mellitus during an exacerbation in the past or a hospitalisation for diabetes mellitus in the two years preceding the study
5. Need for regular oxygen therapy
6. Maintenance therapy with antibiotics
7. Known alpha1 antitrypsine deficiency
8. Disorders or progressive diseases, which influence seriously the ability to walk (e.g. amputation, paralysis, progressive muscle diseases)
Date of first enrolment01/11/2004
Date of final enrolment01/07/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Medisch Spectrum Twente
Enschede
7500 KA
Netherlands

Sponsor information

Medisch Spectrum Twente (Netherlands)
Hospital/treatment centre

P.O. Box 50000
Enschede
7500 KA
Netherlands

http://www.ziekenhuis-mst.nl/
ROR logo https://ror.org/033xvax87

Funders

Funder type

Charity

Astmafonds (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2011 Yes No
Results article results 01/10/2014 Yes No
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