Condition category
Respiratory
Date applied
04/01/2017
Date assigned
17/02/2017
Last edited
17/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and Aims:
Chronic obstructive pulmonary disease (COPD) is the name given to a collection of diseases which affect the lungs. It is characterised by breathlessness, cough and excess mucus production and is often caused by smoking. Pulmonary rehabilitation (PR) is a program of exercise, education and support that is used in patients with COPD to help them improve their physical condition. Hospital run pulmonary rehabilitation (PR) is recommended to be made available to all people with COPD who are receiving the best treatment for them but still feel limited by their breathlessness in performing everyday activities, however this is not practical in most healthcare settings due to lack of resources. Since 2004, Hywel Dda University Health Board has only been able offer PR to people who have moderate to severe breathlessness. Although the service is popular with patients and their carers and it has achieved results in comparison, there remains a considerable waiting list of up to 12 months. Hywel Dda University Health Board along with the Educational Programme for Patients (EPP) have developed a community based pulmonary rehabilitation programme that uses both health=care professionals and lay tutors to equally deliver the course to participants who have COPD but a mild amount of breathlessness. The aim of this study is to assess whether this program is effective at helping patients to manage their condition by looking at people who have taken part in the programme and those who have not.

Who can participate?
Adults aged 35 years and over who have COPD with mild breathlessness who are taking part in the community based pulmonary rehabilitation programme within the six months of the study and those who have signed up for community based pulmonary rehabilitation programme but do not have one in their area within the six month period.

What does the study involve?
For the participants taking part in the community based pulmonary rehabilitation programme, data about their background information and health is collected by the during community rehabilitation programme assessments at day one, week nine and month six by the course tutors. Data from primary care (GP level) and secondary care (specialist level) is also collected by the research team by reviewing medical databases and patient medical records within three months of the patients completing the course. Participants who have signed up but can’t yet access the programme continue as normal and attend appointments on day one, week nine and month six so that background and health data can be collected. The research team also reviews patient notes and medical databases within three months of the final assessment. The data collected in each group are then compared.

What are the possible risks and benefits of participating?
There are no notable benefits involves for participants. There is a small risk that completing the questionnaires in this study may be distressing for some people and participants may find attending the venue to take part inconvenient.

Where is the study run from?
The study is run from Hywel Dda University Health Board takes place in local community areas covered by the Health Board (UK)

When is the study starting and how long is it expected to run for?
March 2016 to March 2018

Who is funding the study?
EPP Cymru (UK)

Who is the main contact?
Mrs Sarah Hicks
sarah.hicks@wales.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Sarah Hicks

ORCID ID

Contact details

Hywel Dda University Health Board
Room G35
Hafen Derwen
St Davids Park
Jobswell Road
Carmarthen
SA31 3BB
United Kingdom
+44 1267 239662
sarah.hicks@wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS206119

Study information

Scientific title

How effective is a COMmunity based Pulmonary rehabilitation progrAmme for patients with mild to moderate Chronic ObsTructive Pulmonary Disease? (COMPACT study)

Acronym

COMPACT

Study hypothesis

The aim of this study is to assess whether the community based pulmonary rehabilitation programme is effective in improving the self management skills of participants within the time period of the programme and for up to 6 months compared to a comparator group who do not undertake the programme.

Ethics approval

London Bridge Research Ethics Committee, 22/12/2016, ref: 16/LO/1858

Study design

Single-centre observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Chronic obstructive pulmonary disease

Intervention

30 people who undertake the community based pulmonary rehabilitation programme (intervention group) within a 6 month timescale and 30 people who sign up for a community based pulmonary rehabilitation programme but do not have one in their area within the 6 month period (comparator group) will be asked to have their data collected by the research team for comparison.

For those in the intervention group, health status data is going to be collected as usual during the community rehabilitation programme at assessment (Day 1, Week 9 and Month 6) by the course tutors who will be unaware of whether the group member has consented to be part of the research or not. Data from primary care and secondary care will be collected by the research team by review of medical databases and patient medical records within the 3 months post course completion.

For those in the comparator group, the health status data will be collected by the research team at assessments on Day 1, Week 9 and Month 6. The research team will also review the medical notes and medical databases within 3 months of the final assessment.

In both groups, data to be collected includes demographics, pulse, blood pressure, oxygen levels, incremental shuttle walk tests, FEV1, MRC score, EQ5D, CAT, primary care contacts, secondary care contacts including A&E attendances and OPD attendances.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

COPD self management is assessed through review of the primary and secondary care databases by the researcher to assess the number of health care professional face to face contacts, telephone contacts and admissions to hospital during the 6 months pre / post attending a community based pulmonary rehabilitation programme.

Secondary outcome measures

1. Participants and Control group: Exercise tolerance of the Intervention group compared to the Controls is assessed using data observed during incremental walk tests at Day 1, Week 9 and 6 Months
2. Participants and Control group: General Health of the Intervention Group compared to the Control group is assessed using the validated, self completed, EQ5D questionnaire at Day 1, Week 9 and 6 Months
3. Participants and Control group: COPD symptom control of the Intervention Group compared to the Control group is assessed using the validated, self completed, COPD Assessment Test (CAT) questionnaire at Day 1, Week 9 and 6 Months
4. For participants only: The cost effectiveness of the community based pulmonary rehabilitation programme will be assessed using statistical analysis via SPSS version 22.2 (Chicago, Illinois) based upon changes in EQ5D, healthcare contacts and deaths within the 12 month research period (6 months pre course and 6 months post course)
5. For participants only, completion rates for the community based pulmonary rehabilitation programme and reasons for non completion will be assessed using the attendance register for the participants course at the 9 week assessment
6. For participants only, reasons for non completion of the community based pulmonary rehabilitation programme will be assessed by telephone interview with the participant by the research team at the 9 week assessment

Overall trial start date

23/03/2016

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Cases:
1. Above 35 years old
2. Male and female
3. Clinical Diagnosis of COPD
4. MRC dyspnoea score of 1-2
5. Self enrolled onto and able to complete a community based pulmonary rehabilitation programme within 6 month time period (Jan - June 2017)

Control:
1. Above 35 years old
2. Male and Female
3. Clinical Diagnosis of COPD
4. MRC dyspnoea score of 1-2
5. Self enrolled onto but not able to start a community based pulmonary rehabilitation programme within the 6 month time period (Jan - June 2017)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 participants in 2x case control groups

Participant exclusion criteria

1. Those unwilling or unable to provide written consent.
2. Resident in an area not covered by the Hywel Dda University Health Board EPP team.
3. Those unable or unwilling to attend at least 5 of the planned 7 ‘COPD +’ sessions (Group A only).
4. MRC dyspnoea score 3-5

Recruitment start date

10/01/2017

Recruitment end date

30/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hywel Dda University Health Board
Jobswell Road
Carmarthen
SA31 3BB
United Kingdom

Sponsor information

Organisation

Hywel Dda University Health Board Research & Development Department

Sponsor details

Clinical Research Unit
Prince Philip Hospital
Llanelli
SA14 8QF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

EPP Cymru

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results may be published in scientific journals and presented at conferences.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Sarah Hicks (Sarah.Hicks@wales.nhs.uk

Intention to publish date

01/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes