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

14 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

200

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Hannah Wheeler
  • Número de telefone: 612-624-2642
  • E-mail: hwheeler@umn.edu

Locais de estudo

  • Estados Unidos
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota
        • Investigador principal:
          • Jude Mikal, PhD
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Social Interaction Frequency and Quality
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Perceived Function, Utility, and Barriers to Engagement With the Social Reminder System
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Minnesota

Colaboradores

National Institute on Aging (NIA)

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

1 de março de 2028

Conclusão do estudo (Estimado)

1 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

13 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de agosto de 2026

Primeira postagem (Real)

19 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Study00027433
  • 2R44AG063683-04 (Concessão/Contrato do NIH dos EUA)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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