Clinical trial NCT05533736: Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia
Official title: Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia: 2019-2021
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cutaneous Leishmaniasis, American
Lead sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas
Sponsor class: OTHER
Collaborators: name: Universidad Icesi
First posted: 2022-09-09
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed description: An effectiveness-implementation sequential explanatory hybrid design type 2 using mixed methods was performed in 2020 and 2021 in two study sites: Pueblo Rico, Risaralda, and Rovira, Tolima. A quasi-experimental study with historical control (standard of care) was designed to evaluate the effectiveness of the community-based intervention supported by mHealth, in terms of monitoring of treatment of patients with cutaneous leishmaniasis. The effectiveness indicators i. number of follow-up contacts, ii. Adherence to treatment, iii. adverse drug reactions, and iv. the therapeutic response were compared between the intervention and control groups.

After the effectiveness evaluation was completed, three outcomes were assessed to inform the implementation of the community-based use of the app: acceptability, usability, and fidelity.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: ii. Percent adherence to treatment
timeFrame: 6 months
measure: iii. Adverse drug reactions
timeFrame: 6 months
measure: iv. Therapeutic response
timeFrame: 6 months
Secondary outcomes:
measure: Implementation of the community-based strategy to follow patients with cutaneous Leishmaniasis was evaluated by three outcomes. i. Acceptability
timeFrame: 6 months
measure: ii. Usability
timeFrame: 6 months
measure: iii. Fidelity
timeFrame: 6 months
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas
state: Valle
Study officials:
References:
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