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

Primary Purpose

Cutaneous Leishmaniasis, American

Status

Completed

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

About this trial

This is an interventional health services research trial for Cutaneous Leishmaniasis, American

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

Control group: Standard of care

Arm Description

Patients with cutaneous leishmaniasis are followed with the Guaral+ST app by Community Health Leaders. This intervention was not randomized

Control group: Standard of Care: Registers historical patients with cutaneous leishmaniasis is followed in the health facility by physicians according to national guidelines.

Outcomes

Primary Outcome Measures

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.

ii. Percent adherence to treatment

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

iii. Adverse drug reactions

Frequency of adverse drug reactions: number of adverse drug reactions

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

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT05533736

First Posted

September 1, 2022

Last Updated

September 7, 2022

Sponsor

Centro Internacional de Entrenamiento e Investigaciones Médicas

Collaborators

Universidad Icesi

1. Study Identification

Unique Protocol Identification Number

NCT05533736

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

September 1, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centro Internacional de Entrenamiento e Investigaciones Médicas

Collaborators

Universidad Icesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Leishmaniasis, American

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

Arm Type

Experimental

Arm Description

Patients with cutaneous leishmaniasis are followed with the Guaral+ST app by Community Health Leaders. This intervention was not randomized

Arm Title

Control group: Standard of care

Arm Type

No Intervention

Arm Description

Control group: Standard of Care: Registers historical patients with cutaneous leishmaniasis is followed in the health facility by physicians according to national guidelines.

Intervention Type

Other

Intervention Name(s)

Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

Title

ii. Percent adherence to treatment

Description

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

Time Frame

6 months

Title

iii. Adverse drug reactions

Description

Frequency of adverse drug reactions: number of adverse drug reactions

Time Frame

6 months

Title

iv. Therapeutic response

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

6 months

Title

ii. Usability

Description

Time Frame

6 months

Title

iii. Fidelity

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

City

Cali

State/Province

Valle

ZIP/Postal Code

5930

Country

Colombia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30383809

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.

Results Reference

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PubMed Identifier

33382382

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.

Results Reference

background

PubMed Identifier

22310560

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.

Results Reference

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PubMed Identifier

29329311

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, Lopez 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, Velez 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.

Results Reference

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PubMed Identifier

20957426

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.

Results Reference

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PubMed Identifier

25881735

Citation

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.

Results Reference

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PubMed Identifier

30274498

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):102. doi: 10.3390/tropicalmed3030102.

Results Reference

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

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