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Completed

NCT Number: NCT05533736

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

Cali, Valle del Cauca Department, 5930, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

Other

Community Health leaders follow patients using the Guaral+ST app at final of treatment, and on days 90 and 180 after initiating the treatment.

Primary outcomes

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

    Time frame: 6 months

    The number of follow-up contacts between patients and health system or community health workers.

  2. ii. Percent adherence to treatment

    Time frame: 6 months

    Relation between the number of doses administrated and the number of doses formulated by the physicians x 100.

  3. iii. Adverse drug reactions

    Time frame: 6 months

    Frequency of adverse drug reactions: number of adverse drug reactions

  4. iv. Therapeutic response

    Time frame: 6 months

    • Cure: Completely re-epithelialised lesions on days 90 -180 after initiation of treatment
    • Failure: >50% increase in ulcer size from baseline at any time during evaluation or incomplete re-epithelialised on days 90-180

Secondary outcomes

  1. Implementation of the community-based strategy to follow patients with cutaneous Leishmaniasis was evaluated by three outcomes. i. Acceptability

    Time frame: 6 months

    It refers to the perception among implementation stakeholders that the app is appealing, suitable, or satisfactory by a qualitative evaluation at three levels: community health leaders, health workers, and, and patients.

  2. ii. Usability

    Time frame: 6 months

    Refers to the degree to which the app can be used by community health leaders and health workers to achieve quantified objectives of effectiveness, efficiency, and satisfaction. It was evaluated using qualitatively at two levels: community health leaders and health workers.

  3. iii. Fidelity

    Time frame: 6 months

    It refers to the compliance (percentage) with the implementation strategy as described in the protocol. It was measured at two levels: Community Health Leaders and physicians.

Sponsors and collaborators

Lead sponsor

Centro Internacional de Entrenamiento e Investigaciones Médicas

Other

Collaborators

  • Universidad Icesi

Registry information

Official study title

Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia: 2019-2021

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2022
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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