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

C

Centro Internacional de Entrenamiento e Investigaciones Médicas

Status

Completed

Conditions

Cutaneous Leishmaniasis, American

Treatments

Other: Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

Study type

Interventional

Funder types

Other

Identifiers

NCT05533736
201875

Details and patient eligibility

About

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

Full 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.

Enrollment

105 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

105 participants in 2 patient groups

Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis
Experimental group
Description:
Patients with cutaneous leishmaniasis are followed with the Guaral+ST app by Community Health Leaders. This intervention was not randomized
Treatment:
Other: Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis
Control group: Standard of care
No Intervention group
Description:
Control group: Standard of Care: Registers historical patients with cutaneous leishmaniasis is followed in the health facility by physicians according to national guidelines.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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