Reduction of disability in leprosy through enhanced self-care
| ISRCTN | ISRCTN17277275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17277275 |
| Secondary identifying numbers | TLMTI C-62 |
- Submission date
- 17/08/2022
- Registration date
- 25/08/2022
- Last edited
- 11/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Leprosy, also known as Hansen's disease (HD), is a long-term infection by the bacteria Mycobacterium leprae or Mycobacterium lepromatosis. Infection can lead to damage of the nerves, respiratory tract, skin, and eyes. This nerve damage may result in a lack of ability to feel pain, which can lead to the loss of parts of a person's extremities from repeated injuries or infection through unnoticed wounds. An infected person may also experience muscle weakness and poor eyesight.
Nerve damage in leprosy increases the risk of repeated injuries and ulcers in the feet and hands, leading to the disfigurement of limbs which in turn may result in stigma, restriction in social participation and loss of work.
We aim to evaluate an enhanced self-care program in collaboration with stakeholders, which will be embedded within a larger care and prevention program called the Replicable Model (system - National leprosy eradication program: strengthening project in Chhattisgargh district , India).
Who can participate?
Patients with neuropathy in their eyes, hands and feet from the three blocks (sub-unit of district) of Janjgir-Champa district.
What does the study involve?
This is a prospective interventional cohort study where the intervention (enhanced self-care program) will be delivered by the Replicability Model project team through the National Leprosy Program. The research (RIGHT research project) team will evaluate the program using a mixed methods approach. The enhanced self-care program will be implemented through front-line health workers (Mitanin) of the public health system in Janjgir-Champa district, Chhattisgarh state, India. Patients will be followed up twelve months after the implementation of the enhanced self-care program. The main outcomes will be the prevalence of ulcers among those at risk of an ulcer; the total surface area of ulcers (cm2) among those with ulcers and disability severity level as measured using the Eye, Hand and Foot score (EHF score). Qualitative observations of the implementation of the progress will be made.
What are the possible benefits and risks of participating?
Benefits: Training and uptake of enhanced self-care that will reduce and prevent disability due to leprosy.
Risks: No risks identified
Where is the study run from?
TLM Bethesda Leprosy Home and Hospital (India)
When is the study starting and how long is it expected to run for?
January 2022 to July 2024
Who is funding the study?
UK National Institute for Health Research (NIHR) Research and Innovation for Global Health Transformation (RIGHT) Programme
Who is the main contact?
Dr Joydeepa Darlong, joydeepa.darlong@leprosymission.in
Professor Richard Lilford, r.j.lilford@bham.ac.uk
Contact information
Principal Investigator
The Leprosy Mission Trust India
CNI Bhavan
16 Pandit Pant Marg
New Delhi
110001
India
 ORCID ID |
0000-0002-3242-8875 |
|---|---|
| Phone | +91 (11) 4353 3300 |
| joydeepa.darlong@leprosymission.in |
Principal Investigator
University of Birmingham
Murray Learning Centre
Birmingham
B15 2TT
United Kingdom
| ORCID ID |
0000-0002-0634-984X |
|---|---|
| Phone | +44 (0)121 414 6772 |
| r.j.lilford@bham.ac.uk |
Study information
| Study design | Prospective interventional cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | 42244 PIS v1.1.pdf |
| Scientific title | REductioN of disABility in Leprosy through Enhanced self care in Janjgir-Champa district, Chhattisgarh, India |
| Study acronym | ENABLE India |
| Study objectives | Does enhanced self care practices delivered by frontline workers enhance uptake and adherence to self care to prevent and reduce disabiltiy due to leprosy ? |
| Ethics approval(s) | Approved 26/03/2022, TLMTI Research Ethics Committee (16, Pandit Pant Marg, CNI Bhavan, New Delhi, 110001, India; +91 9811912026; monicathomaschandy@gmail.com), ref: TLMTI C62. |
| Health condition(s) or problem(s) studied | Prevention of disability in leprosy (Hansen's disease) |
| Intervention | Prevention and reduction of disability by self-care in the community is facilitated using existing public health systems and Mitanins (front-line health worker) .The self-care intervention will be staggered across the districts and their constituent Primary Health Centres (PHCs). The NIHR RIGHT team have developed international guidelines documents for self-care. These will be contextualized and will be called 'Enhanced self-care intervention', for implementation and dissemination in Chhattisgarh, in collaboration with colleagues responsible for implementing and supporting self-care in the community. The delivery of the self-care intervention to the patients will be through Mitanins (health care workers) facilitated by community development officers (CDO) of the Replicability Model (implementer of the intervention) team. In India, Mitanins are the pillars of the National Health Mission in implementation activities of various health programs and are familiar with, and accepted in their own communities, as the first person to be called for health-related problems. There are about 20 Mitanins supervised by one Mitanin trainer (MTs) in each block of a district. All MTs from the blocks the ENABLE study is recruiting from will receive training on the enhanced self-care intervention by CDOs of the Replicability Model team in a one-off training session. The MTs in turn will train their respective existing Mitanins, in a phased manner. The Mitanins will deliver the self-care intervention in the form of training and demonstration to the patients from their respective villages and follow them up. The follow-up will be done monthly, documenting the conditions of the limbs in a register. The CDO’s of the Replicability Model team will support Mitanins in provision of footwear, self-care kits and assistive devices. If there is deterioration in the impairments / ulcers, they will refer to the primary health centre. The evaluation of enhanced self-care intervention will happen in three blocks of the Champa-Janjgir district. All patients with neuropathy due to leprosy, at risk for developing ulcers (had an ulcer in the past) and currently having an ulcer will be included in the self-care program. |
| Intervention type | Behavioural |
| Primary outcome measure | Quantitative outcome 1. The prevalence of ulcers among those at risk of an ulcer is measured using case record form for clinical assessment at baseline , 3 months , 6 months and 12 months. 2. The total surface area of ulcers (cm2) among those with ulcers is measured using photographs at baseline, 3 months, 6 months and 12 months. 3. Disability severity level: Eye, Hand and Foot score (EHF score) is measured using case record form for clinical assessment at baseline, 3 months, 6 months and 12 months. Qualitative outcome 1. Fidelity: 1.1. Evaluation of Mitanin trainers' training measured using pre and post test questionnaire at on off training program for trainers 1.2. Evaluation of cascaded training of Mitanins by Mitanin trainers to measure delivery of training using observation checklist and knowledge gain using pre and post questionnaires. 2. Delivery of intervention 2.2. Home visit records (of over 4 week period prior to data extraction) measured at 4 weeks after Post intervention assessment at 3 months, 4 weeks after Post intervention assessment 2 at 6 months and 4 weeks before final intervention assessment at 12 months 2.3. Observation of home visits documented using checklist at least 12 weeks after cascaded training of Mitanins 2.4. Interview with mitanins documented using interview guide at least 12 weeks after cascaded training of Mitanins 3. Community member experience of intervention and impact 3.1. Interview with patients and family members using interview guide at least 12 weeks after cascaded training of Mitanins. 3.2. Interview with community representatives using interview guide at least 12 weeks after cascaded training of Mitanins. |
| Secondary outcome measures | 1. Psychological Outcome 1.1. Quality of life is measured using EQ 5D 3L and EQ VAS (visual analogue scale) at Baseline, 6 months and 12 months 1.2. Subjective well being is measured using life satisfaction questionnaire at Baseline, 6 months and 12 months 2. Social outcomes using Participation scale at Baseline, 6 months and 12 months. |
| Overall study start date | 07/01/2022 |
| Completion date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 16 clusters each with 5 to 10 people affected by leprosy who are at risk of an ulcer and another 5 to 8 patients with impairments in eye, hands with or without impairment in the foot who will require self-care. |
| Total final enrolment | 261 |
| Key inclusion criteria | All patients with neuropathy due to leprosy, at risk for developing ulcers (had an ulcer in the past) or currently have an ulcer will be included in the study. |
| Key exclusion criteria | Children less than 18 years old |
| Date of first enrolment | 25/08/2022 |
| Date of final enrolment | 28/01/2023 |
Locations
Countries of recruitment
- India
Study participating centre
Janjgir-Champa district
Champa
495671
India
Sponsor information
University/education
Room 119
Aston Webb Building
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 4158011 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to publish results in a high-impact peer-reviewed journal. The results of the study will be reported to collaborators of this study. Equal credit will be given to those who have collaborated in the trial. The findings will be shared with the patients and communities through the networks of The Leprosy Mission Trust India, who have extensive experience in working with the patient communities. Findings will be presented at conferences of Indian Association of Leprologists (IAL), Indian Association of Dermatologists, Venereologists and Leprologists (IADVL), the Annual Neglected Tropical Disease NGO (NNN) conference, International Leprosy Congress in 2022 and Diabetes disease related conferences. Tools used to disseminate the research output will include: bite-sized research reports in lay format; publication in peer reviewed international journals; public announcements in LMICs; policy briefings; print and online media; the director’s news blog (680+ subscribers); institutional and social media accounts and websites. The context (Chhattisgarh) specific principles and guidelines to promote self-care practice in the community with an emphasis on prevention of recurrent leprosy ulcers will be disseminated across different networks of The Leprosy Mission Trust India. |
| IPD sharing plan | Data will be shared on request. joydeepa.darlong@leprosymission.in |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 18/08/2022 | No | Yes | |
| Protocol file | version 1.1 | 21/03/2022 | 18/08/2022 | No | No |
| Statistical Analysis Plan | 22/08/2024 | No | No |
Additional files
Editorial Notes
11/03/2025: Total final enrolment added.
10/03/2025: The following changes were made to the study record:
1. The overall study end date was changed from 25/02/2024 to 01/07/2024.
2. The intention to publish date was changed from 31/08/2024 to 31/05/2025.
22/08/2024: The statistical analysis plan was uploaded as an additional file.
26/08/2022: Internal review.
18/08/2022: Trial's existence confirmed by TLMTI Research Ethics Committee
