What are the attitudes and opinions of healthcare staff and patients living with post-tuberculosis lung disease in Kyrgyzstan regarding Pulmonary Rehabilitation?
| ISRCTN | ISRCTN16501214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16501214 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 28/08/2019
- Registration date
- 12/09/2019
- Last edited
- 06/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Tuberculosis 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 in patients with chronic lung disease. Little is known about the effect of Pulmonary Rehabilitation on patients living with Tuberculosis. In order for Pulmonary Rehabilitation to be successful, patient buy-in or motivation is important to ensure patient uptake and completion is maximised. Furthermore, the specific details surrounding a culturally appropriate Pulmonary Rehabilitation programme are unknown. 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 the healthcare workers support the implementation of a clinical Pulmonary Rehabilitation programme. At present, the awareness and opinions of healthcare workers in Kyrgyzstan is unknown. Collecting this data will enhance the implementation of a Pulmonary Rehabilitation programme in Kyrgyzstan.
Who can participate?
Patients diagnosed with post-tuberculosis lung disease or healthcare professionals working with patients with chronic respiratory disease
What does the study involve?
Participants will answer a questionnaire on their attitudes and opinions regarding Pulmonary Rehabilitation
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 Kyrgyzstan. There are no risks to participation.
Where is the study run from?
1. National Center of Cardiology and Internal Medicine Kyrgyzstan
2. Bishkek City TB Hospital Kyrgyzstan
When is the study starting and how long is it expected to run for?
April 2018 to March 2021
Who is funding the study?
National Institute for Health Research (NIHR), UK
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
LE3 9QP
United Kingdom
 ORCID ID |
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
| ORCID ID |
0000-0003-4678-6574 |
|---|---|
| Phone | +441162583113 |
| mwo4@leicester.ac.uk |
Study information
| Study design | Multi-centre observational cross-sectional trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| 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 post-tuberculosis lung disease regards the delivery of a clinical pulmonary rehabilitation programme: Global RECHARGE Kyrgyzstan |
| Study acronym | Global RECHARGE Kyrgyzstan (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) | Approved 16/09/2019, University of Leicester Ethics Committee (The University of Leicester, University Road, Leicester, LE1 7RH, United Kingdom; +44 (0)1162522522; ethicsapp@leicester.ac.uk), ref: 22293 |
| Health condition(s) or problem(s) studied | Post-tuberculosis lung disease |
| Intervention | This is a questionnaire study that will seek to collect the attitudes and opinions on of participants living with post-TB lung disease and health-care professionals regarding pulmonary rehabilitation. Participants will be asked to complete a questionnaire only. There is no follow-up for this study. |
| Intervention type | Other |
| Primary outcome measure | The questionnaire data will be used to: 1. Understand the patients' enthusiasm for Pulmonary Rehabilitation and their preference regards delivery mode 2. Understand the attitudes and beliefs of potential referrers to Pulmonary Rehabilitation and how they might best like to receive information and refer patients into the service |
| Secondary outcome measures | The questionnaire data will be used to: 1. Determine the need for Pulmonary Rehabilitation from patients with chronic lung disease 2. Obtain information on the mode of Pulmonary Rehabilitation that is acceptable to patients 3. Obtain information on the attitudes and beliefs of health care providers who would be potential referrers to Pulmonary Rehabilitation 4. Obtain the views of health care personnel on transfer of information and the mode of referral to the Pulmonary Rehabilitation service 5. Collect preliminary anonymous questionnaire data from potential candidates with chronic lung disease and healthcare workers on the need for Pulmonary Rehabilitation and their individual preferred modes of delivery |
| Overall study start date | 01/04/2018 |
| Completion date | 31/03/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 (100 patient and 100 healthcare workers) |
| Total final enrolment | 214 |
| Key inclusion criteria | 1. Patients diagnosed with post-tuberculosis lung disease, or 2. Healthcare professionals working with patients with chronic respiratory disease |
| Key exclusion criteria | Anyone unable to provide written informed consent |
| Date of first enrolment | 17/09/2019 |
| Date of final enrolment | 19/12/2019 |
Locations
Countries of recruitment
- Kyrgyzstan
Study participating centres
Bishkek
720040
Kyrgyzstan
Bishkek
720040
Kyrgyzstan
Sponsor information
University/education
University road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 (0)1162522522 |
|---|---|
| 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 | 31/03/2021 |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Abstract results | Presented at the 2020 ERS International Congress | 28/10/2020 | 15/08/2022 | No | No |
| Protocol article | 21/02/2022 | 06/10/2022 | Yes | No | |
| Results article | 04/02/2022 | 06/10/2022 | Yes | No |
Editorial Notes
06/10/2022: Publication references added.
15/08/2022: The following changes have been made:
1. The reference added on 05/04/2022 has been removed from this record.
2. An abstract reference has been added.
05/04/2022: Publication reference added.
10/02/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/11/2019 to 19/12/2019.
2. The target number of participants has been changed from "60" to "200 (100 patient and 100 healthcare workers)".
3. The total target enrolment has been changed from 60 to 200
02/04/2020: Internal review.
31/03/2020: Trial's existence confirmed by University Ethics Sub-Committee for Medicine and Biological Sciences.
23/03/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2021 to 01/11/2019.
2. The total final enrolment number was added.
23/10/2019: The ethics approval information has been added.
