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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cutaneous Leishmaniasis, American

Intervention / Treatment
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* Other: Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis<br>Patients with cutaneous leishmaniasis are followed with the Guaral+ST app by Community Health Leaders. This intervention was not randomized | Other: Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis<br>* Community Health leaders follow patients using the Guaral+ST app at final of treatment, and on days 90 and 180 after initiating the treatment.<br>|
| No Intervention: Control group: Standard of care<br>Control group: Standard of Care: Registers historical patients with cutaneous leishmaniasis is followed in the health facility by physicians according to national guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of community-based intervention using the Guaral+ST mobile application was evaluated by four outcomes: i. The number of follow-ups | The number of follow-up contacts between patients and health system or community health workers. | 6 months | 
| ii. Percent adherence to treatment | Relation between the number of doses administrated and the number of doses formulated by the physicians x 100. | 6 months | 
| iii. Adverse drug reactions | Frequency of adverse drug reactions: number of adverse drug reactions | 6 months | 
| iv. Therapeutic response | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation of the community-based strategy to follow patients with cutaneous Leishmaniasis was evaluated by three outcomes. i. Acceptability | 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. | 6 months | 
| ii. Usability | 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. | 6 months | 
| iii. Fidelity | 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. | 6 months |