Condition category
Infections and Infestations
Date applied
04/08/2020
Date assigned
14/08/2020
Last edited
14/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Tuberculosis (TB) is a bacterial infection spread through inhaling tiny droplets from the coughs or sneezes of an infected person. It mainly affects the lungs, but it can affect any part of the body, including the tummy (abdomen), glands, bones and nervous system. TB is a potentially serious condition, but it can be cured if it's treated with the right antibiotics. Multi Drug Resistant Tuberculosis (MDR TB) does not respond to the two most powerful anti TB drugs of choice (Rifampicin and Isoniazid)
MDR TB is an emerging issue in Uganda and worldwide. Our study will first work with health care professionals to develop the best way to deliver end of life (palliative) care alongside existing MDR TB care. We will then test this new model of care in an experiment, comparing patients who receive the new model to those who receive existing care, and asking patients to self-report their wellbeing. Finally, we will ask patients who received the new model how they experienced it and how it may have worked.

Who can participate?
People on treatment for MDR TB in three treatment centers of Mulago National Referral Hospital, Gulu Regional Referral Hospital and Mbale Regional Referral Hospital. Participants need to be aged 18 years or over, able to communicate in English, Luganda, Acholi, Lugisu and able to give informed consent.

What does the study involve?
Patients will randomly be allocated to standard care or standard care plus palliative care offered during routine MDR TB care.
Participants will be interviewed monthly for a total of 5 research interviews.
Participants in the intervention group who will have given consent at their first contact will be individually interviewed. MDR TB patients allocated to the control arm of the trial will receive routine MDR TB care delivered by the designated MDR TB nurses who have not received formal palliative care training.

What are the possible benefits and risks of participating?
There are no direct benefits for those taking part in the study. However, this may be an opportunity for patients to learn ways of managing symptoms and concerns experienced due to MDR TB disease. There are no risks involved to those taking part in the study and every effort will be made not to inconvenience patients.

Where is the study run from?
Mulago National Referral, Mbale Regional Referral, and Gulu Regional Referral Hospitals in Uganda

When is the study starting and how long is it expected to run for?
January 2018 to March 2021

Who is funding the study?
BUILDCare Africa Grant – Kings College London/ Open Society Foundations (UK)

Who is the main contact?
Nasur Buyinza, nbuyinza@hospiceafrica.or.ug

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nasur Buyinza

ORCID ID

Contact details

Institute of Hospice and Palliative Care in Africa
(Hospice Africa Uganda)
Kampala
Box 7757
Uganda
+256 702878609
nbuyinza@hospiceafrica.or.ug

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Nurse-led integrated palliative care for multi drug resistant tuberculosis patients taking anti multi drug resistant TB therapy in Uganda: a randomized controlled trial

Acronym

Study hypothesis

Integrated nurse-led palliative care intervention for Multi Drug Resistant TB patients improves patient self-reported outcomes (symptoms and concerns) compared to standard care.

Ethics approval

1. Approved 25/01/2018, King's College London PNM Research Ethics Subcommittee (Frankin Wilkins Building, 5.9 Waterloo Bridge Wing, Waterloo Rd, London, SE1 9NH, UK; +44 (0)207 848 4020; rec@kcl.ac.uk), ref: HR-19/20-14450
2. Approved 01/11/2018, Hospice Africa Uganda Research and Ethics Committee (Hospice Africa Uganda, P.O. Box 7757, Kampala, Uganda; +256 703184199; research@hospiceafrica.or.ug), ref: none provided
3. Approved 03/04/2019, Uganda National Council for Science and Technology (Plot 6 Kimera Road, Kampala, Uganda; +256 414 705500; no email provided), ref: none provided

Study design

Mixed methods randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Multidrug-resistant tuberculosis

Intervention

MDR TB patients who will have been randomly allocated to the intervention group will receive palliative care from palliative care specialist nurses who will receive a two days intensive integrated palliative care training for MDR TB with regular weekly clinical support supervision from an experienced senior palliative care provider. Options to call for support or referral of complex cases to a specialized palliative care unit will be put in place.

Nurses with previous recognized palliative care training will be trained to provide palliative care services to MDR-TB patients under study. Study participants allocated to the intervention group will receive an initial assessment using an integrated assessment form so developed. These will then be physically followed up either on the ward or at home depending on where they will be at the time of follow up; follow up will be done once every week if a participant is still admitted on the ward and every two weeks if they are at home over the three months period of the study. However for every alternative week, at least one phone contact will be made to participants so as to be able to address any issues that may have arisen in between the review periods. For each review appointment, the standard MDR TB care which comprises of an existing MDR TB care for Uganda will be offered in addition to an adapted MDR-TB palliative care package based on the Hospice Africa Uganda Model which integrates facility based care and home visits. This model is in line with the African Palliative Care Association’ standards for providing palliative care which focuses on holistic assessment of the patient and management of psychological, spiritual, physical and social problems. As may be required on a case by case basis, this minimum palliative care package will be supplemented by additional clinical support.

The intervention will consist of 6 palliative care appointments spread over three months; this will take the form of holistic assessment, care and management of physical, psychological, spiritual, and social needs as well as planning for referral of complicated cases to specialised centres.

MDR TB patients allocated to the control arm of the trial will receive routine MDR TB care delivered by the designated MDR TB nurses who have not received formal palliative care training.

Randomisation:
After collection of baseline information about eligible participants, participants are randomly assigned (1:1) to either intervention or control. We generated a simple computer randomisation and stratified by recruiting centres and block randomisation with various sizes: 4, 6, 8,10 and 12. Randomisation was generated at King's College London. The generated randomisation was then sent to PI (Nasur Buyinza) in Uganda who is implementing randomisation with research assistants.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Self-reported palliative care-related symptoms and concerns (measured using the Integrated APCA African POS) at baseline and then monthly for 4 months

Secondary outcome measures

At baseline and then monthly for 4 months:
1. Quality of life assessed using GHQ-12 and the World Health Organization quality of life (WHOQOL - BREF) assessment tool
2. Social support assessed using MOS Social Support Survey
3. Adherence to treatment which will be measured during clinical assessment using the Adherence and Alcohol tool
4. Service use measured with Client Services Receipt Inventory (CSRI)

Overall trial start date

05/01/2018

Overall trial end date

01/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18 years and above
2. Diagnosis of MDR TB
3. Registered at the MDR TB clinic of the respective study sites
4. Willing to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

n=144

Participant exclusion criteria

All MDR TB patients attending the respective study sites who are unable to memorize past events due to their impaired cognitive ability as judged by attending physicians and all those who cannot express themselves in English or local language will be excluded from this study.

Recruitment start date

18/12/2019

Recruitment end date

30/11/2020

Locations

Countries of recruitment

Uganda

Trial participating centre

Mulago National Referral Hospital
Mulago Hill PO Box 7051
Kampala
Box 7051
Uganda

Trial participating centre

Gulu Regional Referral Hospital
Lira Gulu Road
Kampala
Q7HX+29
Uganda

Trial participating centre

Mbale Regional Referral Hospital
Pallisa Road
Kampala
Box 921
Uganda

Sponsor information

Organisation

King's College London

Sponsor details

Cicely Saunders Institute
Denmark Hill Campus
London
SE9 5PJ
United Kingdom
+44 (0)2078485517
richard.harding@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Charity

Funder name

BUILDCare Africa Grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Network, Ministry of Health Uganda, National policy beneficiaries, implementers, conferences, publish in peer reviewed journals, dissemination events, world TB day among others.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.

Intention to publish date

30/03/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/08/2020: Trial’s existence confirmed by King's College London.