Clinical trial NCT06225986: Living Memory Home-4-Dementia Care Pairs
Official title: The Living Memory Home: Reducing Grief and Improving Relationships Between Home-Based Patients With ADRD and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyadic Family Caregiver-person With Dementia Online Intervention
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-01-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Feasibility of the LMH-4-DCP application as measured by the number of website logins per participant out of total required (minimum= 6).
timeFrame: 2 Weeks
measure: The Feasibility of the LMH-4-DCP study as measured by participant retention, as indicated by the number of participants lost to follow-up.
timeFrame: 2 Weeks
measure: The Feasibility of the LMH-4-DCP study as measured by participant retention, as indicated by the number of recorded dropouts.
timeFrame: 2 Weeks
measure: The Feasibility of the LMH-4-DCP application as measured by the time spent in each activity within the web application.
timeFrame: 2 Weeks
measure: The Feasibility of the LMH-4-DCP study as measured by the proportion of family caregivers who (1) consent to participate.
timeFrame: 2 Weeks
measure: The Feasibility of the LMH-4-DCP study as measured by recruitment rates and the proportion of family caregivers (2) decline participation.
timeFrame: 2 Weeks
measure: 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.
timeFrame: 2 Weeks
measure: The Usability of the LMH-4-DCP application as measured by the System Usability Scale (SUS).
timeFrame: 2 Weeks
measure: The Acceptability of the LMH-4-DCP application as measured by a survey that measures the participants satisfaction and acceptability of the application.
timeFrame: 2 Weeks
measure: The Acceptability of the LMH-4-DCP application as measured by a qualitative survey that measures the participants satisfaction and acceptability of the application.
timeFrame: 2 Weeks
Secondary outcomes:
measure: Change in Grief Severity as measured by the Pre-Loss Grief-12 (PG-12)
timeFrame: Baseline, 2 Weeks
measure: Change in Relationship Quality as measured by the Relational Deprivation Scale.
timeFrame: Baseline, 2 Weeks
measure: Change in Relationship Quality as measured by the Mutuality Scale.
timeFrame: Baseline, 2 Weeks
measure: Change in Relationship Quality as measured by the Relationship Rewards Scale (RSS) Scale.
timeFrame: Baseline, 2 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Holly Prigerson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California; Weill Cornell Medicine
name: Francesca Falzarano, PhD
role: PRINCIPAL_INVESTIGATOR
References: