- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07574281
Effectiveness and Implementation of the DINKNESH Digital Palliative Care Tool in Ethiopia
Effectiveness and Implementation Determinants of the DINKNESH App Compared to Paper-Based Assessment Tools for Palliative Care: A Mixed-Methods Cluster Randomized Trial in Addis Ababa, Ethiopia
The goal of this clinical trial is to learn if a digital health app called DINKNESH is effective for palliative care identification compared to traditional paper-based assessment tools. It will also look at the factors that help or hinder the use of this app in primary care settings.
The main questions it aims to answer are:
Does the DINKNESH app improve palliative care assessments compared to paper forms?
What are the main barriers and facilitators for Health Extension Workers when using the app in their daily work?
We will compare the DINKNESH app to standard paper-based tools to see if digital tools improve clinical assessment and implementation.
Participants will:
Be assessed for palliative care needs using either the DINKNESH mobile app or standard paper forms.
Receive routine follow-up care as determined by their health provider.
(For health workers): Participate in interviews or surveys to discuss their experience using the assigned assessment tool.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Meheret Amare, Doctor of Medicine
- Número de teléfono: +251919373034
- Correo electrónico: meheretyeshitila3@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria
For patients(Quantitative Part):
- Adults aged 18 years or older
- Currently diagnosed with one or more chronic conditions and receiving home-based follow-up care from a participating Family Health Team within the catchment area of a selected study cluster
- Willing to provide verbal informed consent, or has a primary caregiver willing to provide proxy consent
For healthcare workers:
- Staff members of the Family Health Team at the selected clusters
- Involved in delivering or supervising palliative care services during the study period
- For the qualitative part: Participated in the DINKNESH App implementation process and is willing to participate in a Focus Group Discussion (FGD)
Exclusion Criteria
For patients
- Patients whose clinical condition prevents both self-participation and proxy participation in the assessment process
- Patients already formally identified and referred for palliative care prior to the study period
For healthcare workers:
- Staff members planning to be absent for more than 1 day during the six-week active study period
- Healthworkers not present during the training session
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: DINKNESH App
Healthcare workers (Family Health Teams) in these clusters will utilize the DINKNESH mobile application during routine home-based visits to systematically identify and assess patients requiring palliative care.
The app integrates validated tools (SPICT, ECOG, IPOS) and provides clinical decision support for symptom management, counseling, and referral protocols
|
A mobile-based digital health application designed to support Family Health Teams in the systematic identification and assessment of patients with palliative care needs.
The application digitizes validated clinical tools, including the Supportive and Palliative Care Indicators Tool (SPICT), the Eastern Cooperative Oncology Group (ECOG) performance status, and the Integrated Palliative care Outcome Scale (IPOS) along with reference materials
|
|
Comparador activo: Paper based Tool
Family Health Teams in these clusters will provide home-based chronic care services following standard paper based without the use of the digital application.
|
A paper-based clinical assessment protocol designed to support Family Health Teams in the systematic identification and assessment of patients with palliative care needs.
It incorporates the same validated clinical tools used in the intervention arm, including the Supportive and Palliative Care Indicators Tool (SPICT), the Eastern Cooperative Oncology Group (ECOG) performance status, and the Integrated Palliative care Outcome Scale (IPOS), administered manually during routine home visits without the use of a digital application and reference material.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of identification of patients with palliative care needs.
Periodo de tiempo: 6 weeks
|
The primary outcome is the rate of palliative care identifications, calculated as the number of individuals identified as requiring palliative care divided by the total number of chronic patient visit conducted by the Family Health Teams during the study period.
|
6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Qualitative assessment of implementation barriers and enablers.
Periodo de tiempo: 6 weeks
|
Evaluation of implementation determinants (barriers and facilitators) through focus group discussions with health extension workers
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- MPH/039/18
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. .
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