Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
21/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. van der Palen

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR325; Astma Fonds: 3.4.02.12; MEC:P04-13

Study information

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

Acronym

COPE II

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised active-controlled factorial trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

01/11/2004

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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)

Recruitment start date

01/11/2004

Recruitment end date

01/07/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Medisch Spectrum Twente
Enschede
7500 KA
Netherlands

Sponsor information

Organisation

Medisch Spectrum Twente (Netherlands)

Sponsor details

P.O. Box 50000
Enschede
7500 KA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.ziekenhuis-mst.nl/

Funders

Funder type

Charity

Funder name

Astmafonds (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/20951018
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25153706

Publication citations

  1. Results

    Effing T, Zielhuis G, Kerstjens H, van der Valk P, van der Palen J, Community based physiotherapeutic exercise in COPD self-management: a randomised controlled trial., Respir Med, 2011, 105, 3, 418-426, doi: 10.1016/j.rmed.2010.09.017.

  2. Results

    Zwerink M, van der Palen J, Kerstjens HA, van der Valk P, Brusse-Keizer M, Zielhuis G, Effing T, A community-based exercise programme in COPD self-management: two years follow-up of the COPE-II study, Respir Med, 2014 , 108, 10, 1481-1490, doi: 10.1016/j.rmed.2014.07.016.

Additional files

Editorial Notes