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A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement

14 de agosto de 2026 actualizado por: University of Minnesota

This study will evaluate the Social Reminder System, a mobile informatics system designed to support persons with memory concerns and their care partners. The system is intended to aid social integration for persons with memory concerns and improve care coordination and reduce caregiver burden among caregivers.

Researchers will enroll 100 persons with memory concerns and their care partners. Half of the dyads will be randomly assigned to receive the Social Reminder System technology for a 6-month period, and the other half will be randomly assigned to the usual care control group. Participants will complete baseline, 3-month, and 6-month surveys. A subset of participants who receive the technology will also be asked to complete a semi-structured interview after the 6-month survey.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The Social Reminder System has two goals. The first is to aid in the social integration of persons with memory concerns. The second is to improve care coordination and reduce caregiver burden among caregivers. Following a randomized control trial design, the study will assess the impact of the Social Reminder System on both persons with memory concerns and their care partners.

The Social Reminder System app is designed to provide memory prompts to persons with memory concerns on an in-home tablet before and during social visits. Individuals who are part of a person with memory concerns' trusted circle may download a free smartphone app and save a photo of themselves, their names, and familial relationship description that are shared with the person with memory concerns' display. When trusted circle members are within a 10-meter range of the tablet, the person with memory concerns receives a notification that a visitor is in range. The notification includes a photo of the visitor, the visitor's name, and information about their relationship to the person with memory concerns. Reminders continue to appear on the tablet throughout the visit and cease once the visitor is out of range.

The phase 2b technology also allows the person with memory concerns to designate a primary caregiver. For security reasons and to promote care coordination, the care partner will receive a log of visitors who opted in as trusted circle members. The log will include names, dates, and beginning and ending times of each visit.

A total of 100 dyads, consisting of persons with memory concerns and their care partners, will be enrolled. Half of the dyads will be randomly assigned to the Social Reminder System intervention group and half to an attention control group. Participants will complete baseline, 3-month, and 6-month surveys. The baseline survey will be administered before exposure to the intervention or attention control. Follow-up surveys will be administered 3 months and 6 months after enrollment.

The study will also include semi-structured interviews with a subset of dyads randomly assigned to receive the Social Reminder System. Interviews will take place after completion of the final 6-month follow-up survey and will focus on overall reactions to the technology, perceived barriers to engagement with the technology, and short- and long-term outcomes of engagement with the technology that may have been missed in the survey instruments.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Hannah Wheeler
  • Número de teléfono: 612-624-2642
  • Correo electrónico: hwheeler@umn.edu

Ubicaciones de estudio

  • Estados Unidos
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota
        • Investigador principal:
          • Jude Mikal, PhD
        • Contacto:
          • Hannah Wheeler
          • Número de teléfono: 612-624-2642
          • Correo electrónico: hwheeler@umn.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Persons with memory concerns must be English speaking.
  • Persons with memory concerns must self-report a healthcare provider visit due to memory concerns or memory related diagnosis by a physician or other qualified health care provider consistent with having mild-to-moderate memory impairment.
  • Persons with memory concerns must be over the age of 65.
  • Persons with memory concerns must be able to formally consent or assent to participate in the study.
  • Persons with memory concerns must have internet access.
  • Care partners of persons with memory concerns must speak English.
  • Care partners must be 18 years of age and over.
  • Care partners must self-identify as the primary caregiver for the person with memory concerns.
  • Care partners must indicate a willingness to use the Social Reminder System as well as to being randomized to a control group.
  • Care partners must have a mobile phone with internet access in order to install and use the care partner app.

Exclusion Criteria:

  • Those who do not meet the criteria above will be excluded.
  • Persons with memory concerns with severe or no dementia are not eligible.
  • Individuals who score below 6 and above 24 on the TICS-40 will not be eligible.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Social Reminder System
Dyads randomly assigned to this arm will receive the Social Reminder System technology for a 6-month period. The Social Reminder System app is designed to provide memory prompts to persons with memory concerns on an in-home tablet before and during social visits. Care partners will also receive a log of visitors to promote care coordination.
Conductual: Social Reminder System
The Social Reminder System app is designed to provide memory prompts to persons with memory concerns on an in-home tablet before and during social visits. Individuals who are part of a person with memory concerns' trusted circle may download a free smartphone app and save a photo of themselves, their names, and familial relationship description that are shared with the person with memory concerns' display. When trusted circle members are within a 10 meter range of the tablet, the person with memory concerns receives a notification that a visitor is in range. Reminders continue to appear on the tablet throughout the visit and cease once the visitor is out of range. The care partner will also receive a log of visitors, including names, dates, and beginning and ending times of each visit.
Sin intervención: Usual Care Control
Dyads randomly assigned to this arm will receive usual care control. The attention control group will receive a 3-month contact call and a 6-month contact call from the research coordinator. Free information resources, such as brochures or websites of the Alzheimer's Association, may be provided.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Social Interaction Frequency and Quality
Periodo de tiempo: Baseline to 6 months
Change in frequency and quality of social interactions reported by persons with memory concerns and care partners, including in-person visits, phone calls, mail and letters, and computer-mediated communication.
Baseline to 6 months
Change in Pleasant Events and Social Engagement as Assessed by the Pleasant Events Schedule-Alzheimer's Disease
Periodo de tiempo: Baseline to 6 months
Change in pleasant events and social engagement for persons with memory concerns, assessed using the Pleasant Events Schedule-AD.
Baseline to 6 months
Change in Social Support Score
Periodo de tiempo: Baseline to 6 months
Change in social support among persons with memory concerns and care partners, assessed using a five-item social support scale.
Baseline to 6 months
Change in Loneliness
Periodo de tiempo: Baseline to 6 months
Change in loneliness among persons with memory concerns and care partners, assessed using the UCLA Loneliness Scale.
Baseline to 6 months
Change in Caregiver Burden
Periodo de tiempo: Baseline to 6 months
Change in caregiver burden among care partners, assessed using the Zarit Burden Interview.
Baseline to 6 months
Change in Role Captivity Score
Periodo de tiempo: Baseline to 6 months
Change in role captivity among care partners, assessed using a 4-item role captivity scale.
Baseline to 6 months
Change in Role Overload Score
Periodo de tiempo: Baseline to 6 months
Change in role overload among care partners, assessed using a 3-item role overload scale.
Baseline to 6 months
Change in Anxiety as Assessed by the Hospital Anxiety and Depression Scale
Periodo de tiempo: Baseline to 6 months
Change in anxiety among persons with memory concerns and care partners, assessed using the Hospital Anxiety and Depression Scale.
Baseline to 6 months
Change in Depression as Assessed by the Hospital Anxiety and Depression Scale
Periodo de tiempo: Baseline to 6 months
Change in depression among persons with memory concerns and care partners, assessed using the Hospital Anxiety and Depression Scale.
Baseline to 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Perceived Function, Utility, and Barriers to Engagement With the Social Reminder System
Periodo de tiempo: Up to 1 month after completion of the 6-month follow-up survey
Semi-structured interviews will assess overall reactions to the Social Reminder System, perceived barriers to engagement with the technology, and short- and long-term outcomes of engagement with the technology that may have been missed in the survey instruments.
Up to 1 month after completion of the 6-month follow-up survey
Change in Service Utilization Among Persons With Memory Concerns
Periodo de tiempo: Baseline to 6 months
Change in service utilization among persons with memory concerns, including nursing home, assisted living, other residential care, hospital stays, and emergency department visits.
Baseline to 6 months
Change in Negative Health Transitions Among Persons With Memory Concerns
Periodo de tiempo: Baseline to 6 months
Change in negative health transitions among persons with memory concerns, including falls and wandering events, assessed by care partner report.
Baseline to 6 months
Change in Quality of Life as Assessed by the Adapted Quality of Life-Alzheimer's Disease Measure
Periodo de tiempo: Baseline to 6 months
Change in quality of life for persons with memory concerns and care partners, assessed using the adapted Quality of Life-Alzheimer's Disease measure.
Baseline to 6 months
Change in Community Engagement as Assessed by the 15-Item Community Engagement Scale
Periodo de tiempo: Baseline to 6 months
Change in community engagement among persons with memory concerns and care partners, assessed using a 15-item scale evaluating frequency, duration, and location of trips outside the home.
Baseline to 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Minnesota

Colaboradores

National Institute on Aging (NIA)

Investigadores

  • Investigador principal: Jude Mikal, PhD, University of Minnesota

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2028

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de agosto de 2026

Publicado por primera vez (Actual)

19 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Study00027433
  • 2R44AG063683-04 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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