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

Cutaneous Leishmaniasis, American Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533736
• Other study ID #: 201875
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2022
• Source: Centro Internacional de Entrenamiento e Investigaciones Médicas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis, American
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Other:
• Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis
Community Health leaders follow patients using the Guaral+ST app at final of treatment, and on days 90 and 180 after initiating the treatment.

Locations

Country	Name	City	State
Colombia	Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas	Cali	Valle

Sponsors (2)

Lead Sponsor	Collaborator
Centro Internacional de Entrenamiento e Investigaciones Médicas	Universidad Icesi

Country where clinical trial is conducted

Colombia, 

References & Publications (7)

Agarwal S, Perry HB, Long LA, Labrique AB. Evidence on feasibility and effective use of mHealth strategies by frontline health workers in developing countries: systematic review. Trop Med Int Health. 2015 Aug;20(8):1003-14. doi: 10.1111/tmi.12525. Epub 2015 May 14. Review. — View Citation

Carrion C, Robles N, Sola-Morales O, Aymerich M, Ruiz Postigo JA. Mobile Health Strategies to Tackle Skin Neglected Tropical Diseases With Recommendations From Innovative Experiences: Systematic Review. JMIR Mhealth Uhealth. 2020 Dec 31;8(12):e22478. doi: 10.2196/22478. — View Citation

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. — View Citation

Mieras LF, Taal AT, Post EB, Ndeve AGZ, van Hees CLM. The Development of a Mobile Application to Support Peripheral Health Workers to Diagnose and Treat People with Skin Diseases in Resource-Poor Settings. Trop Med Infect Dis. 2018 Sep 15;3(3). pii: E102. doi: 10.3390/tropicalmed3030102. — View Citation

Navarro A, Rubiano L, Arango JD, Rojas CA, Alexander N, Saravia NG, Aronoff-Spencer E. Developing mobile health applications for neglected tropical disease research. PLoS Negl Trop Dis. 2018 Nov 1;12(11):e0006791. doi: 10.1371/journal.pntd.0006791. eCollection 2018 Nov. Review. — View Citation

Olliaro P, Grogl M, Boni M, Carvalho EM, Chebli H, Cisse M, Diro E, Fernandes Cota G, Erber AC, Gadisa E, Handjani F, Khamesipour A, Llanos-Cuentas A, López Carvajal L, Grout L, Lmimouni BE, Mokni M, Nahzat MS, Ben Salah A, Ozbel Y, Pascale JM, Rizzo Molina N, Rode J, Romero G, Ruiz-Postigo JA, Gore Saravia N, Soto J, Uzun S, Mashayekhi V, Vélez ID, Vogt F, Zerpa O, Arana B. Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. PLoS Negl Trop Dis. 2018 Jan 12;12(1):e0006141. doi: 10.1371/journal.pntd.0006141. eCollection 2018 Jan. — View Citation

Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	iii. Adverse drug reactions	Frequency of adverse drug reactions: number of adverse drug reactions	6 months
Primary	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	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
Secondary	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
Secondary	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