What are the attitudes and opinions of healthcare staff and patients with chronic lung disease in Uganda regards pulmonary rehabilitation?
| ISRCTN | ISRCTN44754061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44754061 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 28/08/2019
- Registration date
- 12/09/2019
- Last edited
- 14/09/2021
- 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 Uganda 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 Uganda, Africa and many other low- and middle- income countries. This study aims to look at how ready the people living with lung conditions and healthcare professionals in Uganda are for PR if it were made available as part of normal healthcare.
Who can participate?
People living with lung conditions, specifically chronic obstructive lung disease (COPD) or lung disease as a result of tuberculosis (TB)
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 Uganda. There are no risks to participation.
Where is the study run from?
Makerere University Lung Institute, Makerere University College of Health Sciences, Upper Mulago Hill, Kampala, Uganda, P.O. Box 7749
When is the study starting and how long is it expected to run for?
Anticipated start date 30/09/2019 running until 31/03/2021 (this will be updated in line with ethical approvals)
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 study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Not specified |
| 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 lung disease regards the delivery of a clinical pulmonary rehabilitation programme: Global RECHARGE Uganda |
| Study acronym | Global RECHARGE Uganda (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) | 1. Approved 02/09/2019, Mulago Hospital Research and Ethics Committee, Mulago Hill, Kampala, Uganda; +256 0752-818584, evelynnamwase@gmail.com), ref: MHREC 1478 2. Approved 03/10/2019, University of Leicester Research Ethics Committee (University Rd, Leicester, LE1 7RH; +44 (0)1162522522; ethics@leicester.ac.uk). ref: 22349 |
| Health condition(s) or problem(s) studied | Post tuberculosis lung disease |
| Intervention | Eligible and interested patients, after providing written informed consent, will be given a brief questionnaire in outpatient and primary care clinics. 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. Patients can either complete the questionnaire in the clinic, or return them shortly afterwards in a sealed envelope by post. Eligible and interested healthcare professionals working in the hospital, in primary care or in the community, who provide written informed consent, will be given a brief questionnaire 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. Individuals can either complete the questionnaire on-site or return it in a sealed envelope. We will collect no personal data, except for the professional background and years of experience in managing people with chronic lung disease. |
| Intervention type | Not Specified |
| Primary outcome measure | The readiness of patients and healthcare professionals for Pulmonary Rehabilitation 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 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 are determined using the questionnaire at the time of consent. |
| 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 | 51 patients and 30 staff |
| Total final enrolment | 81 |
| Key inclusion criteria | 1. Diagnosis of COPD 2. Lung disease following TB treatment 3. Healthcare staff |
| Key exclusion criteria | Anyone unable to provide written informed consent |
| Date of first enrolment | 24/01/2020 |
| Date of final enrolment | 10/08/2020 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Upper Mulago Hill
Kampala
P.O. Box 7749
Uganda
Sponsor information
University/education
University road
Leicester
LE17RH
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 | 31/12/2021 |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | 10/08/2021 | 14/09/2021 | Yes | No |
Editorial Notes
14/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
10/02/2021: The following changes have been made:
1. The recruitment start date has been changed from 06/01/2020 to 24/01/2020.
2. The recruitment end date has been changed from 31/03/2020 to 10/08/2020.
3. The target number of participants has been updated from "50 patients and 30 staff" to "51 patients and 30 staff".
4. The total target enrolment number has been updated from 80 to 81.
03/04/2020: The intention to publish date has been changed from 31/03/2021 to 31/12/2021.
02/03/2020: The recruitment start date was changed from 30/09/2019 to 6/01/2020.
23/10/2019: The ethics approval information has been added.
29/08/2019: Trial's existence confirmed by the National Institute for Health Research.
