Dyadic Family Caregiver-person With Dementia Online Intervention
Conditions
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.
Interventions
BEHAVIORALLMH-4-DCP
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.
BEHAVIORALLMH-4-DCP access without reminiscence activities
Participants in the attention control condition will have access to a version of LMH-4-DCP excluding reminiscence-specific activities.
Sponsors
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Feasibility of the LMH-4-DCP Application as Measured by the Number of Website Logins Per Participant Out of Total Required (Minimum = 6). | 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. |
| The Feasibility of the LMH-4-DCP Study as Measured by Participant Retention, as Indicated by the Number of Participants Lost to Follow-Up. | 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. |
| The Feasibility of the LMH-4-DCP Study as Measured by Participant Retention, as Indicated by the Number of Recorded Dropouts. | 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. |
| The Feasibility of the LMH-4-DCP Application as Measured by the Time Spent in Each Activity Within the Web Application. | 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. |
| The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of Family Caregivers Who (1) Consent to Participate. | 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. |
| The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of Family Caregivers (2) Decline Participation. | 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. |
| 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. | 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. |
| The Usability of the LMH-4-DCP Application as Measured by the System Usability Scale (SUS). | 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. |
| The Acceptability of the LMH-4-DCP Application as Measured by a Survey That Measures the Participants Satisfaction and Acceptability of the Application. | 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. |
| The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Grief Severity as Measured by the Pre-Loss Prolonged Grief Revised (PG-12-R) Instrument. | 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. |
| Change in Relationship Quality as Measured by the Relational Deprivation Scale. | 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. |
| Change in Relationship Quality as Measured by the Mutuality Scale. | 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. |
| Change in Relationship Quality as Measured by the Relationship Rewards Scale. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHolly Prigerson, PhD
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORFrancesca Falzarano, PhD
University of Southern California; Weill Cornell Medicine
Participant flow
Recruitment details
Enrollment occurred between November 2024 and May 2025. Participants were recruited via ResearchMatch.org, social media advertisements, posted flyers, and announcements at the Duke-University of North Carolina Alzheimer's Disease Research Center.
Pre-assignment details
Of 174 individuals assessed for eligibility, 106 met eligibility criteria. 74 participants were enrolled; however, 6 were excluded prior to assignment to an arm due to provision of false or inaccurate information. As a result, 68 participants started the study. The study population consisted exclusively of caregivers of persons living with ADRD. All Participant Flow counts represent caregivers, including enrollment, allocation, follow-up, completion, and discontinuation.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 14.3 |
| Caregiver Kinship to Care Recipient Adult-child | 18 Participants |
| Caregiver Kinship to Care Recipient Friend | 0 Participants |
| Caregiver Kinship to Care Recipient Other extended family | 8 Participants |
| Caregiver Kinship to Care Recipient Spouse | 4 Participants |
| Education Level Associate's degree | 3 Participants |
| Education Level Bachelor's degree or higher | 45 Participants |
| Education Level Some college or less | 5 Participants |
| Education Level Trade or vocational school | 2 Participants |
| Employment Status Employed full-time | 30 Participants |
| Employment Status Employed part-time | 6 Participants |
| Employment Status Homemaker | 8 Participants |
| Employment Status No response | 0 Participants |
| Employment Status Retired | 5 Participants |
| Employment Status Unemployed | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Marital Status Married or partnered | 21 Participants |
| Marital Status Never married | 18 Participants |
| Marital Status Separated or divorced | 2 Participants |
| Marital Status Widowed | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 68 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
None listed