CompletedNot Applicable

Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia

Colombia105 participantsStarted 2020-03-01

Plain-language summary

An effectiveness-implementation sequential explanatory hybrid design type 2 was performed in two rural communities of Colombia. A quasi-experimental study with historical control (standard of care) was designed to estimate the effectiveness of community-based intervention using the Guaral+ST mobile application (app). Three implementation outcomes were evaluated: acceptability and usability by qualitative methods, and fidelity by quantitative methods

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients followed by CHL with the app (effectiveness evaluation): * Diagnosis confirmed by microscopy of tissue smear or culture * Any age and gender * Medical prescription for antileishmanial treatment * Approved and signed informed consent * Availability of CHL to monitor treatment of the patients in the community Inclusion Criteria patients who received the standard of care (effectiveness evaluation): * Clinical records of patients with confirmed CL at most two years prior to the start of this study * Any age and gender * Received antileishmanial treatment based on national guidelines Inclusion criteria for participants of implementation evaluation (Community Health Leaders) * Residents of the rural areas of study sites * Voluntary participation in the monitoring of patients using the mobile app

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The effectiveness of community-based intervention using the Guaral+ST mobile application was evaluated by four outcomes: i. The number of follow-ups

Timeframe: 6 months

ii. Percent adherence to treatment

Timeframe: 6 months

iii. Adverse drug reactions

Timeframe: 6 months

iv. Therapeutic response

Timeframe: 6 months

Trial details

NCT IDNCT05533736

SponsorCentro Internacional de Entrenamiento e Investigaciones Médicas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-01

View on ClinicalTrials.gov More Cutaneous Leishmaniasis, American trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The effectiveness of community-based intervention using the Guaral+ST mobile application was evaluated by four outcomes: i. The number of follow-ups

Timeframe: 6 months

ii. Percent adherence to treatment

Timeframe: 6 months

iii. Adverse drug reactions

Timeframe: 6 months

iv. Therapeutic response

Timeframe: 6 months