Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas
Cali, Valle del Cauca Department, 5930, Colombia
NCT Number: NCT05533736
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
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Cali, Valle del Cauca Department, 5930, Colombia
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.
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):
Inclusion criteria
patients who received the standard of care (effectiveness evaluation):
Inclusion criteria
for participants of implementation evaluation (Community Health Leaders)
Community Health leaders follow patients using the Guaral+ST app at final of treatment, and on days 90 and 180 after initiating the treatment.
Time frame: 6 months
The number of follow-up contacts between patients and health system or community health workers.
Time frame: 6 months
Relation between the number of doses administrated and the number of doses formulated by the physicians x 100.
Time frame: 6 months
Frequency of adverse drug reactions: number of adverse drug reactions
Time frame: 6 months
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.
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.
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.
Centro Internacional de Entrenamiento e Investigaciones Médicas
Other
Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia: 2019-2021
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.
Published trials that share one or more normalized conditions with this study.
NCT06449040
Cutaneous Leishmaniasis, American, Euglenozoa Infections
Presidente Tancredo Neves, Estado de Bahia, Brazil
View Trial DetailsNCT06000514
Cutaneous Leishmaniasis, American, Euglenozoa Infections
Presidente Tancredo Neves, Estado de Bahia, Brazil
View Trial DetailsNCT03829917
Cutaneous Leishmaniasis, American, Euglenozoa Infections
Jorochito, SC, Bolivia
View Trial DetailsNCT07149753
Cutaneous Leishmaniasis, Cutaneous Leishmaniasis, American
Floridablanca, Santander Department, Colombia
View Trial Details