What are the attitudes and opinions of healthcare staff and patients living with chronic obstructive lung disease in India regards pulmonary rehabilitation?
| ISRCTN | ISRCTN13804142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13804142 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 28/08/2019
- Registration date
- 12/09/2019
- Last edited
- 12/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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 February 2022
Who is funding the study?
National Institute for Health Research.
Who is the main contact?
Dr Mark Orme, mwo4@leicester.ac.uk.
Contact information
Public
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre- Respiratory
Glenfield Hospital
Groby Road
Leicester
LE39QP
United Kingdom
 ORCID ID |
0000-0003-4678-6574 |
|---|---|
| Phone | 01162583113 |
| mwo4@leicester.ac.uk |
Scientific
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre- Respiratory
Glenfield Hospital
Groby Road
Leicester
LE39QP
United Kingdom
| ORCID ID |
0000-0003-4678-6574 |
|---|---|
| Phone | 01162583113 |
| mwo4@leicester.ac.uk |
Study information
| Study design | A multi-centre observational, cross-sectional trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | Global RECHARGE India (Survey) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 | Other |
| 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 study start date | 01/04/2018 |
| Completion date | 01/02/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 601 |
| Total final enrolment | 577 |
| Key inclusion criteria | 1. Diagnosed with chronic obstructive pulmonary disease 2. Healthcare professionals working with patients with chronic respiratory disease 3. Hospital administrators |
| Key exclusion criteria | Anyone unable to provide written informed consent |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 31/10/2021 |
Locations
Countries of recruitment
- India
Study participating centre
Gram: Lavale, Tal: Mulshi
Pune
412115
India
Sponsor information
University/education
University road
Leicester
LE1 7RH
England
United Kingdom
| Phone | 01162522522 |
|---|---|
| smd8@leicester.ac.uk | |
| Website | https://le.ac.uk |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 20/12/2020 | 12/01/2023 | No | No |
Additional files
Editorial Notes
12/01/2023: Protocol uploaded (not peer reviewed).
06/04/2022: Total final enrolment added.
05/04/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2021 to 01/02/2022.
2. The intention to publish date was changed from 31/10/2022 to 31/03/2023.
11/10/2021: The intention to publish date has been changed from 31/03/2021 to 31/10/2022.
0/02/2021: Recruitment for this study is no longer paused and the following changes have been made:
1. The recruitment start date has been changed from 01/10/2020 to 01/04/2021.
2. The recruitment end date has been changed from 31/12/2020 to 31/10/2021.
27/07/2020: The recruitment start date was changed from 01/05/2020 to 01/10/2020.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
02/03/2020: The following changes were made to the trial record:
1. The trial participating centre was changed from Chest Research Foundation to Symbiosis International (Deemed University).
2. The recruitment start date was changed from 30/11/2019 to 01/05/2020.
3. The recruitment end date was changed from 30/09/2020 to 31/12/2020.
05/11/2019: The recruitment start date was changed from 30/09/2019 to 30/11/2019.
30/08/2019: Trial's existence confirmed by the National Institute for Health Research.
