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?
Symbiosis International (Deemed University) (India)
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. 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.
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
01/05/2020
Recruitment end date
31/12/2020
Locations
Countries of recruitment
India
Trial participating centre
Symbiosis International (Deemed University)
Symbiosis Knowledge Village
Gram: Lavale, Tal: Mulshi
Pune
412115
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
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