Condition category
Respiratory
Date applied
28/08/2019
Date assigned
12/09/2019
Last edited
02/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

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
LE3 9QP
United Kingdom
+44 (0)1162583113
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
LE3 9QP
United Kingdom
+441162583113
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 post-tuberculosis lung disease regards the delivery of a clinical pulmonary rehabilitation programme: Global RECHARGE Kyrgyzstan

Acronym

Global RECHARGE Kyrgyzstan (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

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

Study design

Multi-centre observational cross-sectional trial

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

01/04/2018

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients diagnosed with post-tuberculosis lung disease, or
2. Healthcare professionals working with patients with chronic respiratory disease

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

60

Total final enrolment

214

Participant exclusion criteria

Anyone unable to provide written informed consent

Recruitment start date

17/09/2019

Recruitment end date

01/11/2019

Locations

Countries of recruitment

Kyrgyzstan

Trial participating centre

National Center of Cardiology and Internal Medicine
3 Togolok Moldo Street
Bishkek
720040
Kyrgyzstan

Trial participating centre

Bishkek City TB Hospital
211 Elebesov Street
Bishkek
720040
Kyrgyzstan

Sponsor information

Organisation

University of Leicester

Sponsor details

University road
Leicester
LE1 7RH
United Kingdom
+44 (0)1162522522
smd8@leicester.ac.uk

Sponsor type

University/education

Website

https://le.ac.uk

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

Publication citations

Additional files

Editorial Notes

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.