MIND-the-SKIN: Digital Toolkit for Skin Diseases in LMICs

Sponsor

Tulane University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05300399

Collaborator

Osaka University (Other), Hope Commission International (Other), Institut Pasteur of Cote d'Ivoire (Other), Institut Raoul Follereau (Other), Centre Suisse de Recherches Scientifiques en Cote d'Ivoire (Other), Trilobite, Ltd. (Other)

1,364

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

101.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the early detection and effective management of skin diseases using the mHealth app in Cote d'Ivoire, a mixed-methods pilot trial will be conducted in Cote d'Ivoire. The pilot trial will consist of 3 phases: phase 1, development and improvement of the mHealth app; phase 2, pilot trial to evaluate the usability of the mHealth app for local healthcare providers in Cote d'Ivoire; and phase 3, pilot trial to evaluate the effectiveness of case detection and management of skin diseases with the mHealth app in Cote d'Ivoire. The pilot study will be implemented as a 2-arm trial with local healthcare providers and patients with skin diseases over a 3-month follow-up period.

Condition or Disease	Intervention/Treatment	Phase
Skin Diseases	Device: mHealth app	N/A

Detailed Description

Background: The prevalence of skin diseases is extremely high in sub-Saharan Africa, among which are skin neglected tropical diseases (skin NTDs) that could lead to life-long disabilities and deformities if not diagnosed and treated early. To achieve early detection and early treatment of these skin diseases, we developed a mobile health application (mHealth app): 'eSkinHealth'.

Objective: To evaluate the early detection and effective management of skin diseases using the mHealth app in Cote d'Ivoire.

Methods: A mixed-methods pilot trial will be conducted in Cote d'Ivoire and will consist of 3 phases: phase 1, development and improvement of the mHealth app; phase 2, pilot trial to evaluate the usability of the mHealth app for local healthcare providers in Cote d'Ivoire; and phase 3, pilot trial to evaluate the effectiveness of case detection and management of skin diseases with the mHealth app in Cote d'Ivoire. The pilot study will be implemented as a 2-arm trial with local healthcare providers and patients with skin diseases over a 3-month follow-up period.

Local healthcare providers (i.e., doctors, nurses, or community health workers/volunteers) must meet all eligibility requirements to enroll in the study. Eligible local healthcare providers are; (1) 18 years or older, (2) working at primary health centers or clinics in Cote d'Ivoire, (3) able to read and speak fluent French, (4) willing to participate in the pilot study for the 3-month study duration and use a provided tablet with the eSkinHealth app if they were assigned in the intervention group, and (5) able to consent for oneself. Ineligible local healthcare providers will be defined as those who (1) are planning to leave the job at the clinics within the study period and (2) have difficulty in operating mobile devices.

Eligible patients will be defined as those are; (1) clinically suspected or diagnosed of skin NTDs (Buruli ulcer, leprosy, lymphatic filariasis, yaws, or other skin NTDs) or have other clinically diagnosed skin conditions, (2) diagnosed of concomitantly fewer than three identified skin conditions, and (3) able to consent for oneself. Ineligible patients have (1) more than three skin conditions and (2) clinically diagnosed skin conditions outside of the target site.

For phase 2, we will use a validated questionnaire, the system usability scale (SUS). The outcome measurement is an average score of SUS. The SUS consists of 10 statements with responses in the form of a five-point Likert scale (e.g., 1: strongly disagree, 5: strongly agree). We will use the French-language version of SUS. We will assess the usability at baseline, midpoint (6 weeks), and at the end of the study (12 weeks).

For phase 3, differences in case numbers diagnosed and followed up between the intervention group (with the app) and the control group (without the app) will be measured as the primary outcome of this study. We will also evaluate the effectiveness of the intervention on secondary outcomes, including engagement with the app's platform and willingness to use it. The engagement of local healthcare providers will be measured via data usage, including the frequency of visits to the platform and time spent there.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1364 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

MIND-the-SKIN Project: Multi-functional Innovative Digital Toolkit for the Skin Diseases in LMICs and Beyond

Actual Study Start Date :

Feb 14, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: With mHealth app	Device: mHealth app The local healthcare providers will be assigned to an intervention group receiving the mHealth app to be used in their daily practices or a control group.
No Intervention: Without mHealth app

Arm

Intervention/Treatment

Experimental: With mHealth app

Device: mHealth app

The local healthcare providers will be assigned to an intervention group receiving the mHealth app to be used in their daily practices or a control group.

No Intervention: Without mHealth app

Outcome Measures

Primary Outcome Measures

Differences in case numbers diagnosed and followed up [12 weeks]
Differences in case numbers diagnosed and followed up between the intervention group (with the app) and the control group (without the app) will be measured as the primary outcome of this study.

Secondary Outcome Measures

Effectiveness of the app [12 weeks]
We will assess the engagement with the app's platform and willingness to use it. The engagement of local healthcare providers will be measured via data usage, including frequency of visit to the platform and time spent there.
Usability of the app [12 weeks]
We will assess the usability of the app at baseline, midpoint (6 weeks), and at the end of the study (12 weeks). The outcome measurement is an average score of SUS. The SUS consists of 10 statements with responses in the form of a five-point Likert scale (e.g., 1: strongly disagree, 5: strongly agree). We will use the French-language version of SUS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Phase 2: Local healthcare providers (i.e., doctors, nurses, or community health workers/volunteers)

Inclusion Criteria:

18 years or older
Working at primary health centers or clinics in Cote d'Ivoire
Able to read and speak fluent French
Willing to participate in the pilot study for the 3-month study duration and use a provided tablet with the eSkinHealth app if they were assigned to the intervention group
Able to consent for oneself

Exclusion Criteria:

Planning to leave their job at the clinics within the study period
Difficulty operating mobile devices

Phase 3: Patients with skin diseases

Inclusion Criteria:

Clinically suspected or diagnosed with skin NTDs (Buruli ulcer, leprosy, and yaws) or have other clinically diagnosed skin conditions
Diagnosed of concomitantly fewer than three identified skin conditions
Able to consent for oneself