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
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: 06/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Mark Orme
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
Email	mwo4@leicester.ac.uk

Dr Mark Orme
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
Email	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 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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/03/2021

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	All
Target sample size at registration	200
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

National Center of Cardiology and Internal Medicine

3 Togolok Moldo Street
Bishkek
720040
Kyrgyzstan

Bishkek City TB Hospital

211 Elebesov Street
Bishkek
720040
Kyrgyzstan

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		04/02/2022	06/10/2022	Yes	No
Protocol article		21/02/2022	06/10/2022	Yes	No
Abstract results	Presented at the 2020 ERS International Congress	28/10/2020	15/08/2022	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.