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Completed

NCT Number: NCT06225986

Living Memory Home-4-Dementia Care Pairs

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10021, United States

About this study

The goal of this randomized controlled trial is to evaluate the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) web application, a dyadic online psychosocial reminiscence platform, to reduce feelings of pre-loss grief and improve relationship quality in individuals with dementia and their family caregivers ('Care Pairs').

The main aims of this study are:

  • To evaluate the feasibility and acceptability of the LMH-4-DCP platform.
  • To explore the influence of the LMH-4-DCP intervention on reducing feelings of pre-loss grief and enhancing relationship quality in the care pair

Caregiver participants randomized to the intervention condition will be asked to log-in to LMH-4-DCP and complete reminiscence activities three times per week for two weeks. Researchers will compare the intervention group to an attention control condition, which includes LMH-4-DCP use without reminiscence-specific features, 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Family Caregivers:

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

Exclusion criteria

Caregiver exclusion criteria:

  • 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.

PwD exclusion criteria:

  • 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.

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 2 Weeks

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

    Time frame: 2 Weeks

    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.

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

    Time frame: 2 Weeks

    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.

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

    Time frame: 2 Weeks

    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.

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

    Time frame: 2 Weeks

    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.

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

    Time frame: 2 Weeks

    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.

  7. 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.

    Time frame: 2 Weeks

    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.

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

    Time frame: 2 Weeks

    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.

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

    Time frame: 2 Weeks

    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.

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

    Time frame: 2 Weeks

    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?"

Secondary outcomes

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

    Time frame: Baseline, 2 Weeks

    The caregivers' pre-loss grief is assessed using the validated 12-Item Prolonged Grief Revised (PG-12-R) Measure. Scores range from 12-60, with higher scores indicative of greater feelings of pre-loss grief.

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

    Time frame: Baseline, 2 Weeks

    The first measure of relationship quality will be the validated 6-item Relational Deprivation Scale, which measures the perceived loss of relationship as a result of the care-recipient's illness. Response options range from 1 - Not At All to 4 - Completely. Scores range from 6-24, with higher scores indicative of poorer relational quality.

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

    Time frame: Baseline, 2 Weeks

    The second measure of relationship quality will be the validated 15-item Mutuality Scale, which measures the extent of positive aspects of caregiving. Response options range from 0 - Not At All to 4 - A Great Deal. Scores range from 0-60, with higher scores reflecting greater levels of mutuality.

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

    Time frame: Baseline, 2 Weeks

    The third measure of relationship quality will be the 8-item validated Relationship Rewards Scale (RRS) instrument, which includes two subscales assessing caregivers' perceptions of relationship quality prior to the care-recipient's diagnosis ("pre-illness") and at the current time ("current relationship"). Responses range from 1 - Never to 4 - Always. Scores for each subscale range from 4-16, with higher scores indicating greater perceived relationship quality.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

The Living Memory Home: Reducing Grief and Improving Relationships Between Home-Based Patients With ADRD and Their Family Caregivers

Acronym: LMH-4-DCP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.