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
Protocol serial number	NTR325; Astma Fonds: 3.4.02.12; MEC:P04-13
Sponsor	Medisch Spectrum Twente (Netherlands)
Funder	Astmafonds (Netherlands)

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

Primary study design	Interventional
Study design	Randomised active-controlled factorial trial
Secondary study design	Randomised controlled trial
Scientific title	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
Study acronym	COPE II
Study objectives	A 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) studied	Chronic obstructive pulmonary disease (COPD)
Intervention	The 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 type	Behavioural
Primary outcome measure(s)	1. 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
Key secondary outcome measure(s)	1. 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.
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. 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 criteria	1. 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 enrolment	01/11/2004
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Medisch Spectrum Twente

Enschede
7500 KA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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