What are the attitudes and opinions of healthcare staff and patients living with chronic obstructive lung disease in Sri Lanka regards pulmonary rehabilitation?
| ISRCTN | ISRCTN58273367 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58273367 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Version 1 |
| Sponsor | University of Leicester |
| Funder | National Institute for Health Research |
- Submission date
- 28/08/2019
- Registration date
- 12/09/2019
- Last edited
- 15/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
COPD is characterized by progressively irreversible airflow limitation and is a major cause of morbidity and mortality. Pulmonary Rehabilitation includes exercise training, education and behaviour change support and has been successfully employed in health care institutions to improve the quality of life of COPD patients. However, patient buy-in or motivation is a major determinant of the extent of the benefits Pulmonary Rehabilitation attendees will gain. Pulmonary Rehabilitation has not yet been routinely implemented in Sri Lanka, and it is important that patient uptake and completion is maximised if a culturally appropriate Pulmonary Rehabilitation programme is embedded within routine healthcare. Information will be collected from patients that are suitable for attending Pulmonary Rehabilitation regards their opinions and perceptions, to optimise uptake in a culturally appropriate Pulmonary Rehabilitation programme. Similarly, it is important that healthcare workers support the implementation of a clinical Pulmonary Rehabilitation programme. At present, the awareness and opinions of healthcare workers in Sri Lanka is unknown. Collecting this data will enhance the implementation of a Pulmonary Rehabilitation programme in Sri Lanka.
Contact information
Public
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre- Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| 0000-0003-4678-6574 | |
| Phone | +44 (0)1162583113 |
| mwo4@leicester.ac.uk |
Scientific
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre- Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| 0000-0003-4678-6574 | |
| Phone | +44 (0)1162583113 |
| mwo4@leicester.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre observational cross-sectional trial |
| Secondary study design | Cross sectional study |
| Study type | 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 Sri Lanka |
| Study acronym | Global RECHARGE Sri Lanka (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) | University of Leicester, UK |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | A questionnaire based survey |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Patients' enthusiasm for Pulmonary Rehabilitation and their preference regards delivery mode |
| Key secondary outcome measure(s) |
1. The need for Pulmonary Rehabilitation from patients with chronic lung disease |
| Completion date | 31/03/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 420 |
| Total final enrolment | 365 |
| Key inclusion criteria | 1. Patients diagnosed with chronic obstructive pulmonary disease 2. Healthcare professionals working with patients with chronic respiratory disease |
| Key exclusion criteria | Anyone unable to provide written informed consent |
| Date of first enrolment | 01/04/2018 |
| Date of final enrolment | 25/02/2022 |
Locations
Countries of recruitment
- Sri Lanka
Study participating centres
Colombo
Sri Lanka
Sri Lanka
Sri Lanka
Sri Lanka
Sri Lanka
Sri Lanka
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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? |
|---|---|---|---|---|---|
| Results article | 24/01/2022 | 05/04/2022 | Yes | No | |
| Protocol article | 26/11/2020 | 15/08/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/08/2022: Publication reference added.
05/04/2022: Publication reference and total final enrolment added.
10/02/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2021 to 25/02/2022.
2. The target number of participants has been changed from "408" to "282 healthcare professionals & 138 patients".
3. The total target enrolment has been changed from 408 to 420.
4. The IPD sharing statement has been added to the publication and dissemination plan.
5. The Participant level data has been changed from "Available on request" to "To be made available at a later date".
02/03/2020: The target number of participants was changed from 250 to 408.