mHealth for the early diagnosis and effective treatment of cutaneous leishmaniasis

mHealth for the early diagnosis and effective treatment of cutaneous leishmaniasis: a randomized trial comparing the completeness of assessment of adverse events and therapeutic outcome in those whose follow-up is supported by eHealth, versus standard of care, in parasitologically confirmed cases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54865992

Enrollment

Registered

2021-10-08

Start date

2017-01-10

Completion date

Unknown

Last updated

2023-04-10

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

Conditions

Cutaneous leishmaniasis (CL) Infections and Infestations Cutaneous leishmaniasis

Interventions

Design: This is a randomized trial with parallel arms comparing a) follow-up aided by Guaral +ST app to b) standard follow-up led by the IPS (Institución Prestadora de Salud or Institu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Residence in one of the three veredas (townships) previously identified as: 1.1. Having a relatively high incidence of CL in the Colombia National System of Public Health Surveillance (SIVIGILA) 1.2. Safe to work 1.3. Relatively accessible 2. At least one cutaneous lesion

Exclusion criteria

Exclusion criteria: 1. Mucosal leishmaniasis 2. Contraindication to receive treatment in the area of residence, i.e. with condition which requires treatment in the IPS

Design outcomes

Primary

Measure	Time frame
The proportion of participants seen at ideal study week 26, evidenced by standard medical records in the control arm and data entered into the app by the community health worker in the mHealth arm	—

Secondary

Measure	Time frame
1. Adherence calculated as the percentage of the prescribed doses (in ampoules for meglumine antimoniate and in capsules for miltefosine) that are received by the patient during the planned treatment period (20 days for meglumine antimoniate and 28 days for miltefosine), as evidenced by a paper form completed by the patient in the control arm, and this paper form and/or data entered to the app by the community health worker in the mHealth arm 2. Adverse events recorded during the treatment period, in terms of symptoms and frequency in both arms, and of severity in the mHealth arm, as evidenced by a paper form completed by the patient in the control arm, and the paper form and/or data entered to the mobile app made by the community health worker in the mHealth arm 3. Therapeutic response evaluated based on epithelization at week 13, categorized as failure, improvement, or apparent cure; and categorized at week 26 as definitive cure or failure, recorded in person in the control arm, and via app photos in the mHealth arm. 4. The ideal study week when last seen, evidenced by record(s) in a paper form and/or standard medical records in the control arm, and in a paper form and/or mobile app in the mHealth arm	—

Measure

Time frame

1. Adherence calculated as the percentage of the prescribed doses (in ampoules for meglumine antimoniate and in capsules for miltefosine) that are received by the patient during the planned treatment period (20 days for meglumine antimoniate and 28 days for miltefosine), as evidenced by a paper form completed by the patient in the control arm, and this paper form and/or data entered to the app by the community health worker in the mHealth arm 2. Adverse events recorded during the treatment period, in terms of symptoms and frequency in both arms, and of severity in the mHealth arm, as evidenced by a paper form completed by the patient in the control arm, and the paper form and/or data entered to the mobile app made by the community health worker in the mHealth arm 3. Therapeutic response evaluated based on epithelization at week 13, categorized as failure, improvement, or apparent cure; and categorized at week 26 as definitive cure or failure, recorded in person in the control arm, and via app photos in the mHealth arm. 4. The ideal study week when last seen, evidenced by record(s) in a paper form and/or standard medical records in the control arm, and in a paper form and/or mobile app in the mHealth arm

—

Countries

Colombia

Contacts

Public ContactNeal Alexander

nalexander@cideim.org.co+57 (0)2 555 2164 ext 300

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026