Living Memory Home-4-Dementia Care Pairs

NCT06225986 | Completed Results

• 2 other identifiers: 23-07026251R21AG077144
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate an online platform -- the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) for persons with dementia and their family caregivers to engage in reminiscence activities together and record meaningful memories. The main aims of this study are:

• To evaluate the feasibility and acceptability of the LMH-4-DCP platform.
• To explore the potential for LMH-4-DCP to reduce feelings of pre-loss grief and enhancing relationship quality in dementia family caregivers and their care-recipients ('Care-Pairs') Care pair participants will be asked to log-in to LMH-4-DCP and complete study activities three times per week for two weeks. Researchers will compare the intervention group to an attention control condition to see if LMH-4-DCP's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.

Conditions

Dyadic Family Caregiver-person With Dementia Online Intervention

Outcome Measures

Primary Outcomes (10)

• The Feasibility of the LMH-4-DCP Application as Measured by the Number of Website Logins Per Participant Out of Total Required (Minimum = 6).

  The feasibility of the application will be measured by the number of times the participant logs in to the LMH-4-DCP web application. The minimum number of logins recommended to the participants is 6.

  2 Weeks

• The Feasibility of the LMH-4-DCP Study as Measured by Participant Retention, as Indicated by the Number of Participants Lost to Follow-Up.

  Participant retention, as an aspect of feasibility, will be measured by the recorded number of participants lost to follow-up. A number of the enrolled participants who the study team contacted three times, but did not answer or continue participation, will be recorded.

  2 Weeks

• The Feasibility of the LMH-4-DCP Study as Measured by Participant Retention, as Indicated by the Number of Recorded Dropouts.

  Participant retention, as an aspect of feasibility, will be measured by the recorded number of dropouts. A number of the participants who asked to withdraw/drop-out from the study after being enrolled will be recorded.

  2 Weeks

• The Feasibility of the LMH-4-DCP Application as Measured by the Time Spent in Each Activity Within the Web Application.

  The feasibility of the application will be measured by the time spent in each activity. The time will be measured in minutes and seconds. For example, 5 minutes and 30 seconds.

  2 Weeks

• The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of Family Caregivers Who (1) Consent to Participate.

  The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who consent to participate among those who were invited and screened into the study.

  2 Weeks

• The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of Family Caregivers (2) Decline Participation.

  The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who decline to participate among those who were invited and screened into the study.

  2 Weeks

• The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of (3) Are Deemed Ineligible Based on Screening Criteria.

  The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who are deemed ineligible based on screening criteria among those who were invited to participate in the study.

  2 Weeks

• The Usability of the LMH-4-DCP Application as Measured by the System Usability Scale (SUS).

  The usability of the web application will be measured by the System Usability Scale (SUS). This scale is a 10-item assessment of the usability of a system, helping identify areas for improvement. Response options range from 1 - Strongly Disagree to 5 - Strongly Agree. Scores range from 0-100, with higher scores indicative of greater usability.

  2 Weeks

• The Acceptability of the LMH-4-DCP Application as Measured by a Survey That Measures the Participants Satisfaction and Acceptability of the Application.

  The acceptability of the LMH-4-DCP application was assessed among caregiver participants assigned to the intervention arm using a study-specific survey evaluating usability, engagement, acceptability, and suggestions for improvement. Participants rated their agreement with statements such as "I enjoyed my experience using the LMH-4-DCP application" on a five-point Likert scale ranging from 1 - Strongly Disagree to 5 - Strongly Agree. Total scores range from 8 to 40, with higher scores indicating greater satisfaction and acceptability of the intervention.

  2 Weeks

• The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.

  The acceptability of the web application will be measured by the use of open-ended items assessing usability, engagement, acceptability, suggestions for improvement. The intervention group participants will also be administered five open-ended qualitative items asking for feedback on LMH-4-DCP, including: "How was your overall experience using LMH-4-DCP?" and "Which LMH-4-DCP features did you find most valuable? Why?"

  2 Weeks

Secondary Outcomes (4)

• Change in Grief Severity as Measured by the Pre-Loss Prolonged Grief Revised (PG-12-R) Instrument.

  Baseline, 2 Weeks

• Change in Relationship Quality as Measured by the Relational Deprivation Scale.

  Baseline, 2 Weeks

• Change in Relationship Quality as Measured by the Mutuality Scale.

  Baseline, 2 Weeks

• Change in Relationship Quality as Measured by the Relationship Rewards Scale.

  Baseline, 2 Weeks

Study Arms (2)

LMH-4-DCP Intervention

EXPERIMENTAL

Behavioral: LMH-4-DCP

Attention Control Arm

ACTIVE COMPARATOR

Behavioral: LMH-4-DCP access without reminiscence activities

Interventions

LMH-4-DCP BEHAVIORAL

Reminiscence-based intervention for family caregiver-Persons with Dementia (PwD) dyads to record and reflect on meaningful memories to address family caregivers' pre-loss grief and enhance relationship quality.

LMH-4-DCP Intervention

LMH-4-DCP access without reminiscence activities BEHAVIORAL

Participants in the attention control condition will have access to a version of LMH-4-DCP excluding reminiscence-specific activities.

Attention Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Family Caregivers:
• be a primary source of care for a family member in the early to moderate stages of dementia
• years of age or older
• English-speaking
• able to use the internet and has internet access
• residing in the United States

You may not qualify if:

• is not the primary family caregiver of the PwD
• under the age of 18-years-old
• exhibits cognitive impairment (by scoring 3 or more on the SPMSQ)
• does not speak English as a primary language.
• severe cognitive impairment detected by the clinical or study staff using validated, brief screening tools (e.g., a score of 8 errors or more on the SPMSQ)
• does not demonstrate capacity to consent (e.g., a score of 9 or fewer errors on the University of California-San Diego Brief Assessment of Capacity to consent
• PwD is living in a long-term care facility
• does not speak English as a primary language
• is under the age of 18 years old.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related Publications (2)

• Falzarano FB, Greenfield A, Saviano SC, Kolla S, Korian S, Osso F, Miller J, Whitson HE, Maciejewski PK, Prigerson HG. Digital Reminiscence for Predeath Grief Among Family Caregivers of Patients With Dementia: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e268278. doi: 10.1001/jamanetworkopen.2026.8278.

  PMID: 42018322 DERIVED

• Falzarano FB, Greenfield A, Saviano SC, Kolla S, Korian S, Osso F, Miller J, Maciejewski PK, Whitson HE, Prigerson HG. Living Memory Home for Dementia Care Pairs (LMH-4-DCP): study protocol for a pilot randomized trial of a web-based reminiscence intervention for family caregivers and persons with dementia. Pilot Feasibility Stud. 2026 Apr 14;12(1):79. doi: 10.1186/s40814-026-01781-2.

  PMID: 41975550 DERIVED

Limitations and Caveats

The LMH-4-DCP application was unable to capture time spent in each activity. Additionally, due to a technical issue in survey administration, changes in relationship quality (mutuality) could not be measured. As a result, data for both a primary and secondary outcome were either missing or uninterpretable.

Results Point of Contact

• Title: Dr. Holly G. Prigerson
• Organization: Weill Cornell Medical College

hgp2001@med.cornell.edu

646-962-9655

Study Officials

• Holly Prigerson, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Francesca Falzarano, PhD

  University of Southern California; Weill Cornell Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 26, 2024
• Study Start: November 6, 2024
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: July 22, 2026
• Results First Posted: July 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: These data will be shared after we have published the specific aims of this study. Requests for the code used to create LMH-4-Dementia Care Pairs will be reviewed by the investigative team and shared once we have published the findings showing it is safe and therapeutic.
• Access Criteria: 1\) to use the data for research purposes only; 2) not to identify any individual participant; 3) to secure the data using appropriate computer technology such as password-protected servers and files; and 4) to return and/or destroy data after analyses are complete.

Locations

US (1)