Skin DiseasesMIND-the-SKINNCT05300399
Digital Toolkit for Skin Diseases in LMICs
A study testing mHealth app in people with Skin Diseases, run by Tulane University at 1 site in Côte d’Ivoire.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Diseases
- What is being tested?
- mHealth app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,364 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 14 Feb 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- Planning to leave their job at the clinics within the study period
- Difficulty operating mobile devices
- Phase 3: Patients with skin diseases
- More than three skin conditions
- Clinically diagnosed skin conditions outside of the target site
Trial locations and contacts
1 site in 1 country.
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
Rie Yotsu
Sinfra
Rie Yotsu, Ph.D
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Diseases
- Being tested
- mHealth app
- Keywords
- Skin Diseases, Neglected Diseases, Teledermatology, Telemedicine, Remote Consultation
- Medical subject headings
- Skin Diseases, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| With mHealth app | Experimental | Not described Receives: Device: mHealth app |
| Without mHealth app | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
Effectiveness of the app
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.
Measured: 12 weeks
Usability of the app
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start14 Feb 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Osaka University, Hope Commission International, Institut Pasteur of Cote d'Ivoire, Institut Raoul Follereau, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Trilobite, Ltd.
- Responsible party
- Principal investigator, Rie Yotsu, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300399
- Sponsor's protocol ID
- 2020-2054
- Acronym
- MIND-the-SKIN
- Status last verified
- Sep 2022
- First submitted
- 18 Mar 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37632977Yotsu 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.
PubMed 35922062
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND-the-SKIN Project: Multi-functional Innovative Digital Toolkit for the Skin Diseases in LMICs and Beyond
- ClinicalTrials.gov ID
- NCT05300399
- Acronym / sponsor ID
- MIND-the-SKIN / 2020-2054
- Conditions
- Skin Diseases
- Keywords
- Skin Diseases, Neglected Diseases, Teledermatology, Telemedicine, Remote Consultation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,364 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Osaka University, Hope Commission International, Institut Pasteur of Cote d'Ivoire, Institut Raoul Follereau, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Trilobite, Ltd.
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With mHealth app | Experimental | Device: mHealth app |
| Without mHealth app | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- Planning to leave their job at the clinics within the study period
- Difficulty operating mobile devices
- Phase 3: Patients with skin diseases
- More than three skin conditions
- Clinically diagnosed skin conditions outside of the target site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth appThe 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. | Device | With mHealth app |
Primary outcome
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.
2 secondary outcomes
Effectiveness of the app
Time frame: 12 weeks
Usability of the app
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 37632977Yotsu 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.
- Derived from this study: PubMed 35922062Yotsu 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.
Related trials for Skin Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth app in people with Skin Diseases, run by Tulane University at 1 site in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rie Yotsu, MD, MIPH, DTM&H, PhD (+1-(504) 988-5388, ryotsu@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in case numbers diagnosed and followed up (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300399, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.