- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07718334
Impact of a Mobile Application-Based Medication Reminder on Treatment Adherence Among Patients With Chronic Diseases and Memory Impairment: A Nursing Leadership Perspective
Impact of a Mobile Application-Based Medication Reminder on Treatment Adherence Among Patients With Chronic Diseases and Memory Impairment: A Nursing Leadership Perspective - A Quasi Experimental Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Improving medication adherence in patients with chronic illnesses and cognitive decline is a key priority in healthcare management and nursing administration. This quasi-experimental study utilizes a pretest-posttest design to examine the effectiveness of a mobile application-based reminder system designed specifically for patients experiencing memory impairment.
Participants will be selected based on specific inclusion criteria, including being diagnosed with a chronic disease and exhibiting mild-to-moderate memory impairment. Baseline assessments (pretest) will be conducted to measure initial medication adherence levels, patient demographics, and health status. Following the baseline phase, the intervention will be introduced, where participants will utilize the mobile application to receive automated medication alerts and reminders over a specified period. Evaluation (posttest) will be performed post-intervention to analyze changes in adherence rates. The findings are expected to provide insights into how nursing leadership can leverage mobile health (mHealth) technology to design supportive care pathways, enhance patient independence, and reduce clinical complications associated with poor treatment adherence.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Asmaa Elwan Hassan, PhD
- Número de teléfono: +201063776424
- Correo electrónico: asmaaelwan@mans.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Mona Ahmed Gabr, PhD
- Número de teléfono: 201097898593
Ubicaciones de estudio
-
-
Dakahlia Governorate
-
Gamasa, Dakahlia Governorate, Egipto
- Reclutamiento
- Outpatient Clinics, Delta University for Science and Technology
-
Contacto:
- Asmaa Elwan Hassan, PhD
- Número de teléfono: +201063776424
- Correo electrónico: asmaaelwan@mans.edu.eg
-
Contacto:
- Mona Ahmed Gabr, PhD
-
-
Kafr el-Sheikh Governorate
-
Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egipto
- Reclutamiento
- Outpatient Clinics, Kafr El-Sheikh Hospital
-
Contacto:
- Asmaa Elwan Hassan, PhD
- Número de teléfono: +201063776424
- Correo electrónico: asmaaelwan@mans.edu.eg
-
Contacto:
- Mona Ahmed Gabr, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients diagnosed with one or more chronic diseases requiring regular long-term medication.
- Patients exhibiting mild-to-moderate memory impairment or cognitive decline as screened by the Mini-Mental State Examination (MMSE).
- Patients who personally own and are capable of operating a smartphone or have a primary caregiver willing to manage the mobile application.
- Patients aged 18 years and older.
- Patients who provide voluntary informed consent to participate in the study.
Exclusion Criteria:
- Patients with severe cognitive impairment or advanced dementia who cannot interact with mobile technology even with caregiver assistance.
- Patients with severe acute clinical complications or unstable psychiatric conditions.
- Patients participating in another concurrent clinical trial or study targeting medication adherence
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mobile Application Group
Participants in this single-group study will receive training on and utilize a customized mobile application-based medication reminder designed to support adherence to their therapeutic regimens.
|
The intervention consists of a mobile application specifically designed to support medication adherence.
It features automated push notifications, customized reminder alerts matching prescribed medication schedules, and tracking logs.
Participants will be instructed on how to install, configure, and use the application on their personal smartphones.
The system is designed to provide immediate prompts to overcome memory-related adherence barriers.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Medication Adherence (MMAS-8)
Periodo de tiempo: Baseline (pre-intervention) and 3 months post-intervention
|
Medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8).
This self-reported tool evaluates patients' behaviors regarding taking their prescribed chronic medications.
Total scores range from 0 to 8, where a score of 8 indicates high adherence, 6 to <8 indicates medium adherence, and <6 indicates low adherence.
|
Baseline (pre-intervention) and 3 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective Medication Adherence: Medication Possession Ratio (MPR)
Periodo de tiempo: 3 months post-intervention
|
Medication Possession Ratio (MPR) will be calculated using pharmacy refill records to determine the proportion of time the patient has access to their prescribed medication during the study period.
Total scores will range from 0 to 1 (or 0% to 100%), with higher values indicating better adherence.
|
3 months post-intervention
|
|
Objective Medication Adherence: Proportion of Days Covered (PDC)
Periodo de tiempo: 3 months post-intervention
|
Proportion of Days Covered (PDC) will be assessed using pharmacy refill records to measure the percentage of days the patient covered their prescribed medication dosage over the study duration.
Total scores will range from 0 to 1 (or 0% to 100%), where higher values reflect superior medication adherence.
|
3 months post-intervention
|
|
Cognitive Function Status (MMSE)
Periodo de tiempo: Baseline
|
Cognitive impairment levels will be screened using the Mini-Mental State Examination (MMSE) to classify the severity of cognitive/memory impairment among participants.
|
Baseline
|
|
Perceived Nursing Care and Leadership Support
Periodo de tiempo: 3 months post-intervention.
|
Evaluated using the Nursing Care and Leadership Support Assessment Tool to measure patient satisfaction and perception of the supportive role played by nursing leadership during the application-based program.
|
3 months post-intervention.
|
Colaboradores e Investigadores
Patrocinador
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
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Atributos de la enfermedad
- Manifestaciones neuroconductuales
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Trastornos de la memoria
- Enfermedad crónica
- Adherencia a la medicación
Otros números de identificación del estudio
- DFM-IRB 00012367- 26-04-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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. .
Ensayos clínicos sobre Mobile Application-Based Medication Reminder
-
Collabree AGUniversity Hospital, Basel, SwitzerlandTerminadoHipertensión | Adherencia a la medicaciónSuiza
-
Anjali Raja BeharelleMediService AGTerminadoHipertensión | Adherencia a la medicaciónSuiza