NCT05300399

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,364

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

March 18, 2022

Last Update Submit

September 25, 2022

Conditions

Skin Diseases

Keywords

Skin DiseasesNeglected DiseasesTeledermatologyTelemedicineRemote Consultation

Outcome Measures

Primary Outcomes (1)

  • Differences in case numbers diagnosed and followed up

    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 Outcomes (2)

  • Effectiveness of the app

    12 weeks

  • Usability of the app

    12 weeks

Study Arms (2)

With mHealth app

EXPERIMENTAL
Device: mHealth app

Without mHealth app

NO INTERVENTION

Interventions

mHealth appDEVICE

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.

With mHealth app

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Planning to leave their job at the clinics within the study period
  • Difficulty operating mobile devices
  • Phase 3: Patients with skin diseases
  • 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
  • More than three skin conditions
  • Clinically diagnosed skin conditions outside of the target site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rie Yotsu

Sinfra, Côte d’Ivoire

RECRUITING

Related Publications (2)

  • Yotsu RR, Almamy D, Vagamon B, Ugai K, Itoh S, Koffi YD, Kaloga M, Dizoe LAS, Kouadio K, Aka N, Yeboue LKG, Yao KA, Blanton RE. An mHealth App (eSkinHealth) for Detecting and Managing Skin Diseases in Resource-Limited Settings: Mixed Methods Pilot Study. JMIR Dermatol. 2023 Jun 14;6:e46295. doi: 10.2196/46295.

    PMID: 37632977DERIVED

  • Yotsu RR, Itoh S, Yao KA, Kouadio K, Ugai K, Koffi YD, Almamy D, Vagamon B, Blanton RE. The Early Detection and Case Management of Skin Diseases With an mHealth App (eSkinHealth): Protocol for a Mixed Methods Pilot Study in Cote d'Ivoire. JMIR Res Protoc. 2022 Sep 21;11(9):e39867. doi: 10.2196/39867.

    PMID: 35922062DERIVED

MeSH Terms

Conditions

Skin DiseasesNeglected Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Rie Yotsu, MD, MIPH, DTM&H, PhD

CONTACT

+1-(504) 988-5388ryotsu@tulane.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 29, 2022

Study Start

February 14, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations

CÔ(1)