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

2026年8月14日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

200

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Hannah Wheeler
  • 電話番号：612-624-2642
  • メール：hwheeler@umn.edu

研究場所

  • アメリカ
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55455
        • University of Minnesota
        • 主任研究者：
          • Jude Mikal, PhD
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
介入なし：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Social Interaction Frequency and Quality
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Perceived Function, Utility, and Barriers to Engagement With the Social Reminder System
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Minnesota

協力者

National Institute on Aging (NIA)

捜査官

  • 主任研究者：Jude Mikal, PhD、University of Minnesota

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月1日

一次修了 (推定)

2028年3月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年8月13日

QC基準を満たした最初の提出物

2026年8月14日

最初の投稿 (実際)

2026年8月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月19日

QC基準を満たした最後の更新が送信されました

2026年8月14日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Study00027433
  • 2R44AG063683-04 (米国 NIH グラント/契約)

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米国FDA規制医薬品の研究

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米国FDA規制機器製品の研究

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