- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07861945
Integrated Digital Psychosocial and Reproductive Health E-Clinic for Women and Adolescent Girls in Jordan (AMAL-CLINIC)
Integrating Psychosocial and Mental Health Support in Maternal, Prenatal, and Perinatal Health for Better Adolescent Health in Jordan
This implementation study evaluates an integrated digital e-clinic designed to provide mental health, psychosocial, and reproductive health support to women and adolescent girls in Jordan, including Jordanian and Syrian refugee participants and other vulnerable groups. The e-clinic provides individualized psychosocial support, evidence-based educational content, self-help resources, scheduled interactions with trained healthcare providers, and referral pathways for participants requiring additional or specialized services. Participants complete baseline assessments before using the e-clinic and follow-up assessments approximately three months after baseline or following completion of the intervention. The study evaluates changes in mental health and well-being outcomes as well as acceptability, appropriateness, feasibility, accessibility, digital health literacy, reproductive health knowledge and attitudes, service utilization, participant satisfaction, privacy, and engagement with the e-clinic.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study uses a single-group pre-post implementation design to evaluate an integrated e-clinic for women and adolescent girls in Jordan. The digital intervention integrates mental health and psychosocial support with reproductive and maternal health information and referral services.
Participants receive access to individualized psychosocial support, educational and self-help resources, and referral support according to their assessed needs. The intervention incorporates safety and referral procedures for participants requiring urgent or specialized mental health or medical services.
Participants complete a baseline assessment before beginning use of the e-clinic. Follow-up assessment is conducted after completion of the intervention or approximately three months from baseline. Process indicators include the number and type of psychosocial sessions received, use of educational and self-help components, peer or group support where applicable, referral use and completion, and engagement with the digital platform.
Outcomes include depressive symptoms, anxiety symptoms, psychological well-being, post-traumatic stress symptoms, electronic health literacy, reproductive health knowledge, reproductive health attitudes and self-efficacy, acceptability, appropriateness, feasibility, accessibility, privacy, cultural appropriateness, perceived usefulness, service utilization, satisfaction and continuity of care.
The intervention is delivered remotely through a secure electronic e-clinic platform. Participants may access the intervention from their own location, and no routine in-person attendance at the study facility is required
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohammad Sharif Alyahya, PhD
- Número de teléfono: +962 775582824
- Correo electrónico: msalyahya@just.edu.jo
Copia de seguridad de contactos de estudio
- Nombre: Nihaya Al-Sheyab, PhD
- Número de teléfono: +962 790751996
- Correo electrónico: nasheyab@just.edu.jo
Ubicaciones de estudio
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Irbid, Jordán, 22110
- Reclutamiento
- Jordan University of Science and Technology
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Contacto:
- Mohammad Alyahya, PhD
- Número de teléfono: +962 775582824
- Correo electrónico: msalyahya@just.edu.jo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female participants aged 14 to 65 years.
- Jordanian women and adolescent girls and Syrian refugee women and adolescent girls residing in Jordan.
- Eligible to receive psychosocial, mental-health and/or reproductive-health support through the e-clinic.
- Able to access the e-clinic using an internet-connected device or another approved method of access.
- Willing to participate in the e-clinic intervention and study assessments. Able to provide informed consent.
- For participants below the age at which independent consent is permitted under the approved protocol, parental/legal guardian consent and adolescent assent will be obtained.
Exclusion Criteria:
- Acute psychiatric or psychological condition requiring immediate specialist or emergency intervention beyond the scope of the e-clinic.
- Imminent risk of suicide or serious self-harm requiring emergency assessment or intervention.
- Acute medical or reproductive-health emergency requiring urgent face-to-face care.
- Inability to provide informed consent/assent or participate meaningfully in the intervention and assessments.
- Circumstances in which remote participation cannot be conducted safely according to the study safety protocol.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental: Integrated E-Clinic Intervention
Participants receive the integrated digital mental health, psychosocial and reproductive health e-clinic intervention, including individualized psychosocial support, educational and self-help resources, digital health information and referral support according to need. Baseline and approximately three-month follow-up assessments are completed. |
A culturally tailored digital intervention providing integrated mental health and psychosocial support and reproductive health information to women and adolescent girls in Jordan. The intervention includes individualized psychosocial support, scheduled provider interactions, evidence-based educational content, self-help resources, peer/group support where applicable, and referral pathways to appropriate health, mental health and psychosocial services. Participants with urgent or specialized needs are referred according to the study safety and referral protocol. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Primary Outcome 1 -Change From Baseline in Depressive Symptoms Measured Using the Patient Health Questionnaire-9 (PHQ-9) or Patient Health Questionnaire-Adolescent Version (PHQ-A)
Periodo de tiempo: Baseline and approximately 3 months after baseline/completion of the intervention
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Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9) for adult women and the Patient Health Questionnaire-Adolescent version (PHQ-A) for adolescent girls. Each participant will complete only the age-appropriate 9-item instrument. Each item is scored from 0 to 3, and the 9 item scores are summed to produce a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity and lower scores indicate fewer depressive symptoms. Change from baseline will be calculated as the follow-up total score minus the baseline total score; negative change scores indicate improvement. |
Baseline and approximately 3 months after baseline/completion of the intervention
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Primary Outcome 2 - Change From Baseline in Anxiety Symptoms Measured Using the Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: Baseline and approximately 3 months after baseline/completion of the intervention
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Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure. Each item is scored from 0 to 3. Item scores are summed to produce a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity and lower scores indicate fewer anxiety symptoms. Change from baseline will be calculated as the follow-up total score minus the baseline total score; negative change scores indicate improvement. |
Baseline and approximately 3 months after baseline/completion of the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Psychological Well-Being Measured Using the World Health Organization-Five Well-Being Index (WHO-5)
Periodo de tiempo: Baseline and approximately 3 months after baseline.
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Psychological well-being will be assessed using the World Health Organization-Five Well-Being Index (WHO-5), a 5-item measure of subjective psychological well-being. Each item is scored from 0 to 5. The 5 item scores are summed to produce a raw total score ranging from 0 to 25. The raw total is multiplied by 4 to produce the reported WHO-5 score ranging from 0 to 100. Higher scores indicate better psychological well-being. Change from baseline will be calculated as the follow-up score minus the baseline score; positive change scores indicate improvement. |
Baseline and approximately 3 months after baseline.
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Change From Baseline in Post-Traumatic Stress Symptoms Measured Using the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5)
Periodo de tiempo: Baseline and approximately 3 months after baseline.
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Post-traumatic stress symptoms will be assessed using the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), a 20-item self-report measure. Each item is scored from 0 (not at all) to 4 (extremely). The 20 item scores are summed to produce a total score ranging from 0 to 80. Higher scores indicate greater post-traumatic stress symptom severity and lower scores indicate fewer symptoms. Change from baseline will be calculated as the follow-up total score minus the baseline total score; negative change scores indicate improvement. |
Baseline and approximately 3 months after baseline.
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Change From Baseline in Electronic Health Literacy Measured Using the eHealth Literacy Scale (eHEALS)
Periodo de tiempo: Baseline and approximately 3 months after baseline.
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Electronic health literacy will be assessed using the eHealth Literacy Scale (eHEALS), an 8-item self-report measure. Each item is rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The 8 item scores are summed to produce a total score ranging from 8 to 40. Higher scores indicate greater perceived electronic health literacy. Change from baseline will be calculated as the follow-up total score minus the baseline total score; positive change scores indicate improvement. |
Baseline and approximately 3 months after baseline.
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Change From Baseline in Reproductive-Health Knowledge Measured Using the 12-Item Reproductive-Health Literacy/Knowledge Module
Periodo de tiempo: Baseline and approximately 3 months after baseline.
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Reproductive-health knowledge will be assessed using the study-specific 12-item Reproductive-Health Literacy/Knowledge Module. Each item has True, False, and Don't know response options. A correct response is scored 1, while an incorrect or Don't know response is scored 0. The 12 item scores are summed to produce a total score ranging from 0 to 12. Higher scores indicate greater reproductive-health knowledge. Change from baseline will be calculated as the follow-up total score minus the baseline total score; positive change scores indicate improvement. |
Baseline and approximately 3 months after baseline.
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Change From Baseline in Reproductive-Health Attitudes and Self-Efficacy Measured Using a 7-Item Study-Specific Questionnaire
Periodo de tiempo: Baseline and approximately 3 months after baseline.
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Reproductive-health attitudes and self-efficacy will be assessed using a study-specific 7-item questionnaire comprising 3 reproductive-health attitude items and 4 self-efficacy items. Each item is rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). To obtain one reported value, the mean of all 7 items will be calculated for each participant, producing an overall score ranging from 1 to 5. Higher scores indicate more positive reproductive-health attitudes and greater self-efficacy. Change from baseline will be calculated as the follow-up mean score minus the baseline mean score; positive change scores indicate improvement. |
Baseline and approximately 3 months after baseline.
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Acceptability of the E-Clinic Measured Using the Acceptability of Intervention Measure (AIM)
Periodo de tiempo: Approximately 3 months after baseline.
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Acceptability of the e-clinic will be assessed using the 4 scored items in the Acceptability of Intervention Measure (AIM) section of the study questionnaire. The items assess overall satisfaction, appeal, acceptability of using the e-clinic, and willingness to continue using the e-clinic. Each item is rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). The mean of the 4 scored items will be calculated, producing a score ranging from 1 to 5. Higher scores indicate greater perceived acceptability of the e-clinic. |
Approximately 3 months after baseline.
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Participant-Reported Usability of The E-Clinic
Periodo de tiempo: Approximately 3 months after baseline.
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Usability will be assessed using the study-specific 5-item Usability and Accessibility domain of the E-Clinic Implementation Research Questionnaire. The items assess whether the e-clinic content was clear and easy to understand, whether the platform was easy to navigate and use, whether it could be accessed when needed, whether use was feasible given time, device and internet access, and whether it was suitable for the participant's literacy and communication needs. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 5 items will be calculated, producing one domain score ranging from 1 to 5. Higher scores indicate greater perceived usability and accessibility. |
Approximately 3 months after baseline.
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Participant-Reported Privacy, Safety, and Cultural Fit Measured Using the 3-Item Privacy, Safety, and Cultural Fit Domain of the E-Clinic Implementation Research Questionnaire
Periodo de tiempo: Approximately 3 months after baseline.
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Privacy, safety, and cultural fit will be assessed using the study-specific 3-item Privacy, Safety, and Cultural Fit domain of the E-Clinic Implementation Research Questionnaire. The items assess whether the participant felt safe using the e-clinic, whether the e-clinic protected privacy and confidentiality, and whether the e-clinic was culturally respectful and appropriate. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 3 items will be calculated, producing one domain score ranging from 1 to 5. Higher scores indicate more favorable perceptions of privacy, safety, and cultural fit. |
Approximately 3 months after baseline.
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Number of Individual Psychosocial Consultation Sessions Completed
Periodo de tiempo: From enrollment through approximately 3 months after baseline.
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Engagement with one-to-one psychosocial support will be assessed as the total number of individual psychosocial consultation sessions completed by each participant during the follow-up period. The reported value is a count of completed sessions. |
From enrollment through approximately 3 months after baseline.
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Participation in Virtual Group or Peer-Support Sessions
Periodo de tiempo: From enrollment through approximately 3 months after baseline.
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Participants will report whether they used virtual group or peer-support sessions during the follow-up period (No/Yes). The number and percentage of participants reporting participation will be reported. |
From enrollment through approximately 3 months after baseline.
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Number of Educational Modules Completed and Used
Periodo de tiempo: From enrollment through approximately 3 months after baseline.
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Engagement with educational content will be assessed as the number of e-clinic educational modules completed and used by each participant during the follow-up period. The reported value is a count of modules. |
From enrollment through approximately 3 months after baseline.
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Use of E-Clinic Self-Help Exercises or Activities
Periodo de tiempo: From enrollment through approximately 3 months after baseline.
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Participants will report whether they used e-clinic self-help exercises or activities during the follow-up period (No/Yes). The number and percentage of participants reporting use will be reported. |
From enrollment through approximately 3 months after baseline.
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Use of Referral Information or Referral Support
Periodo de tiempo: From enrollment through approximately 3 months after baseline.
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Participants will report whether they used referral information or referral support provided through the e-clinic during the follow-up period (No/Yes). The number and percentage of participants reporting use will be reported. |
From enrollment through approximately 3 months after baseline.
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Participant-Reported Relevance and Usefulness Measured Using the 4-Item Relevance and Usefulness Domain of the E-Clinic Implementation Research Questionnaire
Periodo de tiempo: Approximately 3 months after baseline.
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Perceived relevance and usefulness will be assessed using the study-specific 4-item Relevance and Usefulness domain of the E-Clinic Implementation Research Questionnaire. The items assess whether the content was relevant to the participant's needs, improved knowledge about reproductive and emotional health, improved understanding of emotional distress, stress, anxiety, or sadness, and improved the participant's ability to determine when professional care is needed. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 4 items will be calculated, producing one domain score ranging from 1 to 5. Higher scores indicate greater perceived relevance and usefulness. |
Approximately 3 months after baseline.
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Participant-Reported Emotional Support and Overall Success Measured Using the 3-Item Emotional Support and Overall Success Domain of the E-Clinic Implementation Research Questionnaire
Periodo de tiempo: Approximately 3 months after baseline.
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Emotional support and overall success will be assessed using the study-specific 3-item Emotional Support and Overall Success domain of the E-Clinic Implementation Research Questionnaire. The items assess whether the e-clinic helped the participant feel less alone in dealing with concerns, whether the participant would recommend the e-clinic to others with similar needs, and overall satisfaction with the e-clinic. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 3 items will be calculated, producing one domain score ranging from 1 to 5. Higher scores indicate greater perceived emotional support and overall success. |
Approximately 3 months after baseline.
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Appropriateness of the E-Clinic Measured Using the Intervention Appropriateness Measure (IAM)
Periodo de tiempo: Approximately 3 months after baseline.
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Perceived appropriateness of the e-clinic will be assessed using the 4-item Intervention Appropriateness Measure (IAM) section of the study questionnaire. The items assess whether the e-clinic effectively addresses the participant's health needs, is relevant to the participant's personal situation, provides support appropriate to the participant's concerns, and is a good fit for the type of care needed. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 4 items will be calculated, producing a score ranging from 1 to 5. Higher scores indicate greater perceived appropriateness of the e-clinic. |
Approximately 3 months after baseline.
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Feasibility of the E-Clinic Measured Using the Feasibility of Intervention Measure (FIM)
Periodo de tiempo: Approximately 3 months after baseline.
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Feasibility of the e-clinic will be assessed using the 4-item Feasibility of Intervention Measure (FIM) section of the study questionnaire. The items assess ease of accessing and using the e-clinic, ability to use it without difficulty in daily life, fit with the participant's routine and schedule, and practicality of continued use over time. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 4 items will be calculated, producing a score ranging from 1 to 5. Higher scores indicate greater perceived feasibility of using the e-clinic. |
Approximately 3 months after baseline.
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Receipt of an E-Clinic Referral Recommendation
Periodo de tiempo: From enrollment through approximately 3 months after baseline.
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Participants will report whether an e-clinic provider recommended that they seek additional support or referral during the follow-up period (No/Yes). The number and percentage of participants who received a referral recommendation will be reported. |
From enrollment through approximately 3 months after baseline.
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Referral Completion Status Among Participants Receiving an E-Clinic Referral Recommendation
Periodo de tiempo: From enrollment through approximately 3 months after baseline.
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Among participants who received an e-clinic referral recommendation, referral completion status will be assessed at follow-up using the response categories completed, partially completed, not completed, or not applicable, consistent with the study questionnaire. The number and percentage of referred participants in each category will be reported. |
From enrollment through approximately 3 months after baseline.
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Main Reported Barrier to Referral Completion Among Participants Who Did Not Complete a Recommended Referral
Periodo de tiempo: From enrollment through approximately 3 months after baseline.
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Among participants who did not complete a recommended referral, the main reported barrier will be categorized as cost, transport, family or social barriers, stigma or embarrassment, privacy concerns, time, service unavailable, or other. The number and percentage of participants in each barrier category will be reported. |
From enrollment through approximately 3 months after baseline.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mohammad S Alyahya, Jordan University of Science and Technology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- JUST 20250519
- 110527 - 001 (Otro número de subvención/financiamiento: International Development Research Centre (IDRC)/Canada)
- NOV 2025/188-18 (Otro identificador: Jordan University of Science and Technology Institutional Review Board approval)
- MOH/REC/2025/620 (Otro identificador: Ministry of Health, Jordan, Research Ethics Committee approval)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be made publicly available because the study involves sensitive mental health, psychosocial, reproductive health, and potentially violence- and self-harm-related information, including data from adolescent participants and vulnerable populations. Participant data will be maintained confidentially in accordance with the approved informed consent procedures and the requirements of the Jordan University of Science and Technology and Ministry of Health ethics approvals. Aggregate study findings will be disseminated through scientific publications and presentations.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .