Condition category
Respiratory
Date applied
25/08/2009
Date assigned
08/04/2010
Last edited
10/11/2016
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

Prof Sally Singh

ORCID ID

Contact details

Department of Pulmonary Rehabilitation
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
+44 (0)116 250 2350
sally.singh@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

SPACE for COPD

Study hypothesis

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

Not provided at time of registration

Study design

Parallel-group randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

30/09/2009

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

192

Participant 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

Recruitment start date

30/09/2009

Recruitment end date

30/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o Carolyn Maloney
Gwendolen House
Gwendolen Road
Leicester
LE5 4PY
United Kingdom

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Collaboration in Applied Health Research and Care for Leicestershire, Northamptonshire and Rutland (CLAHRC-LNR)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25186259
2016 economic evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/26703923

Publication citations

Additional files

Editorial Notes

10/11/2016: Publication reference added.