Digital Toolkit for Skin Diseases in LMICs (MIND-the-SKIN)

September 25, 2022 updated by: Rie Yotsu, Tulane University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rie Yotsu, MD, MIPH, DTM&H, PhD
  • Phone Number: +1-(504) 988-5388
  • Email: ryotsu@tulane.edu

Study Locations

  • Côte D'Ivoire
      • Sinfra, Côte D'Ivoire
        • Recruiting
        • Rie Yotsu
        • Contact:
          • Rie Yotsu, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • More than three skin conditions
  • Clinically diagnosed skin conditions outside of the target site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in case numbers diagnosed and followed up
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the app
Time Frame: 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.
12 weeks
Usability of the app
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-2054

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Diseases

Clinical Trials on mHealth app

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe