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Reduction of disability in leprosy through enhanced self-care

REductioN of disABility in Leprosy through Enhanced self care in Janjgir-Champa district, Chhattisgarh, India

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17277275
Enrollment
250
Registered
2022-08-25
Start date
2022-08-25
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of disability in leprosy (Hansen's disease) Infections and Infestations

Interventions

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 st

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Children less than 18 years old

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026