- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07773493
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hannah Wheeler
- Phone Number: 612-624-2642
- Email: hwheeler@umn.edu
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Principal Investigator:
- Jude Mikal, PhD
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Contact:
- Hannah Wheeler
- Phone Number: 612-624-2642
- Email: hwheeler@umn.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Social Interaction Frequency and Quality
Time Frame: 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.
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Baseline to 6 months
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Change in Pleasant Events and Social Engagement as Assessed by the Pleasant Events Schedule-Alzheimer's Disease
Time Frame: Baseline to 6 months
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Change in pleasant events and social engagement for persons with memory concerns, assessed using the Pleasant Events Schedule-AD.
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Baseline to 6 months
|
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Change in Social Support Score
Time Frame: Baseline to 6 months
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Change in social support among persons with memory concerns and care partners, assessed using a five-item social support scale.
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Baseline to 6 months
|
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Change in Loneliness
Time Frame: Baseline to 6 months
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Change in loneliness among persons with memory concerns and care partners, assessed using the UCLA Loneliness Scale.
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Baseline to 6 months
|
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Change in Caregiver Burden
Time Frame: Baseline to 6 months
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Change in caregiver burden among care partners, assessed using the Zarit Burden Interview.
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Baseline to 6 months
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Change in Role Captivity Score
Time Frame: Baseline to 6 months
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Change in role captivity among care partners, assessed using a 4-item role captivity scale.
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Baseline to 6 months
|
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Change in Role Overload Score
Time Frame: Baseline to 6 months
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Change in role overload among care partners, assessed using a 3-item role overload scale.
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Baseline to 6 months
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Change in Anxiety as Assessed by the Hospital Anxiety and Depression Scale
Time Frame: Baseline to 6 months
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Change in anxiety among persons with memory concerns and care partners, assessed using the Hospital Anxiety and Depression Scale.
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Baseline to 6 months
|
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Change in Depression as Assessed by the Hospital Anxiety and Depression Scale
Time Frame: Baseline to 6 months
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Change in depression among persons with memory concerns and care partners, assessed using the Hospital Anxiety and Depression Scale.
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Baseline to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Function, Utility, and Barriers to Engagement With the Social Reminder System
Time Frame: 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.
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Up to 1 month after completion of the 6-month follow-up survey
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Change in Service Utilization Among Persons With Memory Concerns
Time Frame: Baseline to 6 months
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Change in service utilization among persons with memory concerns, including nursing home, assisted living, other residential care, hospital stays, and emergency department visits.
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Baseline to 6 months
|
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Change in Negative Health Transitions Among Persons With Memory Concerns
Time Frame: Baseline to 6 months
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Change in negative health transitions among persons with memory concerns, including falls and wandering events, assessed by care partner report.
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Baseline to 6 months
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Change in Quality of Life as Assessed by the Adapted Quality of Life-Alzheimer's Disease Measure
Time Frame: Baseline to 6 months
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Change in quality of life for persons with memory concerns and care partners, assessed using the adapted Quality of Life-Alzheimer's Disease measure.
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Baseline to 6 months
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Change in Community Engagement as Assessed by the 15-Item Community Engagement Scale
Time Frame: Baseline to 6 months
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jude Mikal, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Tauopathies
- Neurodegenerative Diseases
- Stress, Psychological
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Social Behavior
- Caregiver Burden
- Cognitive Dysfunction
- Alzheimer Disease
- Dementia
- Memory Disorders
- Social Isolation
Other Study ID Numbers
- Study00027433
- 2R44AG063683-04 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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