A Self-management Programme of Activity Coping and Education for Chronic Obstructive Pulmonary Disease: is it effective in primary care?
| ISRCTN | ISRCTN35501175 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35501175 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/08/2009
- Registration date
- 08/04/2010
- Last edited
- 10/11/2016
- 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
Prof Sally Singh
Scientific
Scientific
Department of Pulmonary Rehabilitation
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
| Phone | +44 (0)116 250 2350 |
|---|---|
| sally.singh@uhl-tr.nhs.uk |
Study information
| Study design | Parallel-group randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial to evaluate the effectiveness of a Self-management Programme of Activity Coping and Education for Chronic Obstructive Pulmonary Disease delivered in primary care |
| Study acronym | SPACE for COPD |
| Study objectives | The hypothesis is that a structured education and self-management programme for patients with chronic obstructive pulmonary disease (COPD) will promote independence and improve their quality of life and physical function. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | Participants in the intervention group will receive a 171-page A4 workbook comprising sections on disease education, stress management strategies, breathing control advice and techniques to improve exercise capacity and levels of domestic physical activity. It also includes an individual action plan designed to help cope with exacerbations. Motivational telephone calls will be made at 2 and 5 weeks, 3 and 5 months to encourage participants to complete the manual and pursue an active lifestyle. It is anticipated that participants will have worked through the manual in approximately eight weeks. The control group arm will be monitored in primary care according to the practice framework. Changes in medication during the study period will be recorded. Participants in this group will receive telephone contact to check for GP and hospital contacts and to arrange follow-up visits. Outcome measures will be collected at the initial assessment, and eight weeks and six months after this assessment to determine the short and medium term effects for both study groups. |
| Intervention type | Other |
| Primary outcome measure | Health status determined by Chronic Respiratory Disease Self-Reported Questionnaire - dyspnoea component, measured at the initial assessment, and at 8 weeks and 6 months after this assessment |
| Secondary outcome measures | Measured at the initial assessment, and at 8 weeks and 6 months after this assessment: 1. Domestic physical activity 2. Exercise capacity 3. Mental wellbeing 4. Self-efficacy 5. Health utilisation 6. Task completion 7. Adherence 8. Patient knowledge 9. Exacerbation rates |
| Overall study start date | 30/09/2009 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 192 |
| Key inclusion criteria | Patients (no age limit, either sex) with an established diagnosis of COPD according to international guidelines and Medical Research Council (MRC) dyspnoea scale 2 - 5. |
| Key exclusion criteria | 1. Inability to participate in interventions designed to improve physical capacity, e.g., neurological, locomotive or psychiatric disability 2. Unwillingness to participate 3. Participation in other research projects 4. Inability to read English 5. Participation in rehabilitation in the last 12 months 6. Patients must have been clinically stable for four weeks |
| Date of first enrolment | 30/09/2009 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
LE3 9QP
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Carolyn Maloney
Gwendolen House
Gwendolen Road
Leicester
LE5 4PY
England
United Kingdom
| Website | http://www.uhl-tr.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Collaboration in Applied Health Research and Care for Leicestershire, Northamptonshire and Rutland (CLAHRC-LNR)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/12/2014 | Yes | No | |
| Other publications | economic evaluation | 01/02/2016 | Yes | No |
Editorial Notes
10/11/2016: Publication reference added.
