Condition category
Respiratory
Date applied
28/08/2019
Date assigned
12/09/2019
Last edited
12/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Lung conditions are a major problem in India and many other low- and middle- income countries. In other parts of the world, there is a health service called pulmonary rehabilitation (PR) which has been shown to be highly beneficial to people living with lung conditions. PR involved exercise, education and direct support from healthcare professionals. PR is not routinely provided for people living with lung conditions in India. This study aims to look at how ready the people living with lung conditions and healthcare professionals in Pune, India are for PR if it were made available as part of normal healthcare.

Who can participate?
People living with chronic obstructive lung disease (COPD) and doctors, physiotherapists and hospital administrators.

What does the study involve?
Completion of a short questionnaire.

What are the possible benefits and risks of participating?
Benefits of participation are to contribute to informing the need for and potential design of pulmonary rehabilitation in India. There are no risks to participation.

Where is the study run from?
Chest Research Foundation, Survey No. 15, Marigold Premises, Behind Carnival Cinema, Kalyani Nagar.

When is the study starting and how long is it expected to run for?
September 2019 to September 2020.

Who is funding the study?
National Institute for Health Research.

Who is the main contact?
Dr Mark Orme, mwo4@leicester.ac.uk.

Trial website

Contact information

Type

Public

Primary contact

Dr Mark Orme

ORCID ID

http://orcid.org/0000-0003-4678-6574

Contact details

Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre- Respiratory
Glenfield Hospital
Groby Road
Leicester
LE39QP
United Kingdom
01162583113
mwo4@leicester.ac.uk

Type

Scientific

Additional contact

Dr Mark Orme

ORCID ID

http://orcid.org/0000-0003-4678-6574

Contact details

Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre- Respiratory
Glenfield Hospital
Groby Road
Leicester
LE39QP
United Kingdom
01162583113
mwo4@leicester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Version 1

Study information

Scientific title

The attitudes and opinions of healthcare staff and patients living with chronic obstructive lung disease regards the delivery of a clinical pulmonary rehabilitation programme: Global RECHARGE India

Acronym

Global RECHARGE India (Survey)

Study hypothesis

Despite being a common treatment for chronic lung disease in high income countries, Pulmonary Rehabilitation is not often implemented in low and middle income countries. Data is needed surrounding the perspectives and opinions of medical staff and patients living with chronic lung disease regards implementing and creating a clinical Pulmonary Rehabilitation service.

Ethics approval

Not provided at time of registration

Study design

A multi-centre observational, cross-sectional trial

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Not specified

Trial type

Other

Patient information sheet

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

Condition

COPD

Intervention

Eligible and interested patients, after providing written informed consent, will be given a brief questionnaire in the Chest Research Foundation. The questionnaire will take no more than 5 minutes to complete and will be anonymous. We will collect no clinical data. The questionnaire asks patients to express their opinions as to what a ‘good’ pulmonary rehabilitation programme would look like for them. Patients can either complete the questionnaire in the Chest Research Foundation.

Eligible and interested healthcare professionals, who provide written informed consent, will be given a brief questionnaire at their place of work about their beliefs about rehabilitation, their likelihood to refer patients and how they think this should /could be done. The questionnaire will take no more than 5 minutes to complete and will be anonymous. We will collect no personal data, except for the professional background and years of experience in managing people with chronic lung disease.

316 people living with COPD of which 15-24 will take part in focus groups
115 doctors of which 15-20 will take part in interviews
96 physiotherapists of which 15-20 will take part in interviews
42 hospital administrators of which 15-20 will take part in interviews

Intervention type

Not Specified

Phase

Drug names

Primary outcome measure

The readiness of patients and healthcare professionals for Pulmonary Rehabilitation is measured using the questionnaire at the time of consent.

Secondary outcome measures

1. The need for Pulmonary Rehabilitation from patients with chronic lung disease is determined using the questionnaire at the time of consent.
2. The mode of Pulmonary Rehabilitation that is acceptable to patients is determined using the questionnaire at the time of consent.
3. The attitudes and beliefs of health care providers who would be potential referrers to Pulmonary Rehabilitation are determined using the questionnaire at the time of consent.
4. The views of health care personnel on the transfer of information and the mode of referral to the Pulmonary Rehabilitation service is determined using the questionnaire at the time of consent.
5. The need for Pulmonary Rehabilitation and individual preferred modes of delivery is determined using the questionnaire at the time of consent.

Overall trial start date

01/04/2018

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with chronic obstructive pulmonary disease.
2. Healthcare professionals working with patients with chronic respiratory disease.
3. Hospital administrators.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

601

Participant exclusion criteria

Anyone unable to provide written informed consent

Recruitment start date

30/09/2019

Recruitment end date

30/09/2020

Locations

Countries of recruitment

India

Trial participating centre

Chest Research Foundation
Survey No. 15, Marigold Premises, Behind Carnival Cinema, Kalyani Nagar
Pune
411014
India

Sponsor information

Organisation

University of Leicester

Sponsor details

University road
Leicester
LE1 7RH
United Kingdom
01162522522
smd8@leicester.ac.uk

Sponsor type

University/education

Website

https://le.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

It is anticipated that the results from this study will be published in international journals and presented locally, nationally and internationally at appropriate meetings and conferences. All data that will be collected is anticipated to be published.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/08/2019: trial's existence confirmed by the National Institute for Health Research.