Trial Outcomes & Findings for Living Memory Home-4-Dementia Care Pairs (NCT NCT06225986)
NCT ID: NCT06225986
Last Updated: 2026-07-22
Results Overview
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.
COMPLETED
NA
74 participants
2 Weeks
2026-07-22
Participant Flow
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.
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.
Participant milestones
| Measure |
LMH-4-DCP Intervention
LMH-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.
|
Attention Control Arm
LMH-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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
Baseline
|
33
|
33
|
|
Overall Study
Logged into Assigned Platform
|
29
|
29
|
|
Overall Study
2-Week Follow-Up
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
LMH-4-DCP Intervention
LMH-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.
|
Attention Control Arm
LMH-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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
No Longer Met Eligibility Criteria
|
0
|
1
|
Baseline Characteristics
Living Memory Home-4-Dementia Care Pairs
Baseline characteristics by cohort
| Measure |
LMH-4-DCP Intervention
n=34 Participants
LMH-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.
|
Attention Control Arm
n=34 Participants
LMH-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.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 12.8 • n=9 Participants
|
51.9 years
STANDARD_DEVIATION 14.3 • n=27 Participants
|
49.4 years
STANDARD_DEVIATION 13.7 • n=267 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
54 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
59 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
48 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=9 Participants
|
34 participants
n=27 Participants
|
68 participants
n=267 Participants
|
|
Marital Status
Married or partnered
|
18 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Marital Status
Separated or divorced
|
5 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Marital Status
Never married
|
9 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Education Level
Some college or less
|
7 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Education Level
Associate's degree
|
3 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Education Level
Trade or vocational school
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Education Level
Bachelor's degree or higher
|
22 Participants
n=9 Participants
|
23 Participants
n=27 Participants
|
45 Participants
n=267 Participants
|
|
Employment Status
Employed full-time
|
14 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
|
Employment Status
Employed part-time
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Employment Status
Unemployed
|
3 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Employment Status
Retired
|
5 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Employment Status
Homemaker
|
6 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Employment Status
No response
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Caregiver Kinship to Care Recipient
Spouse
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Caregiver Kinship to Care Recipient
Adult-child
|
21 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Caregiver Kinship to Care Recipient
Other extended family
|
7 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Caregiver Kinship to Care Recipient
Friend
|
0 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants only.
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.
Outcome measures
| Measure |
Attention Control Arm
n=34 Participants
LMH-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.
|
LMH-4-DCP Intervention
n=34 Participants
LMH-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.
|
|---|---|---|
|
The Feasibility of the LMH-4-DCP Application as Measured by the Number of Website Logins Per Participant Out of Total Required (Minimum = 6).
|
4.87 Platform Logins
Standard Deviation 3.79
|
4.57 Platform Logins
Standard Deviation 3.75
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants only.
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.
Outcome measures
| Measure |
Attention Control Arm
n=34 Participants
LMH-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.
|
LMH-4-DCP Intervention
n=34 Participants
LMH-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.
|
|---|---|---|
|
The Feasibility of the LMH-4-DCP Study as Measured by Participant Retention, as Indicated by the Number of Participants Lost to Follow-Up.
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants only.
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.
Outcome measures
| Measure |
Attention Control Arm
n=34 Participants
LMH-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.
|
LMH-4-DCP Intervention
n=34 Participants
LMH-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.
|
|---|---|---|
|
The Feasibility of the LMH-4-DCP Study as Measured by Participant Retention, as Indicated by the Number of Recorded Dropouts.
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: Data were not collected because the developer was ultimately unable to capture duration data. Time spent within each LMH-4-DCP activity was intended to be captured through web application analytics; however, the functionality required to record activity duration data was not successfully implemented during platform development. As a result, duration data were not collected for participants in either study arm, and no analyses could be conducted for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This measure was assessed among caregiver participants only. Of 174 individuals screened, 106 met eligibility criteria and 68 were ineligible. Of the 106 eligible individuals, 74 were enrolled. 6 were excluded before arm assignment for providing false or inaccurate information; therefore, 68 participants started the study.
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.
Outcome measures
| Measure |
Attention Control Arm
LMH-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.
|
LMH-4-DCP Intervention
n=106 Participants
LMH-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.
|
|---|---|---|
|
The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of Family Caregivers Who (1) Consent to Participate.
|
—
|
0.69 proportion of participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This measure was assessed among caregiver participants only. Of 174 individuals screened, 106 met eligibility criteria and 68 were ineligible. Of the 106 eligible individuals, 74 enrolled, 4 declined participation, and 28 were lost to follow-up before consent after 3 unsuccessful contact attempts over a 3-week period. 6 of the 74 enrolled participants were excluded before arm assignment for providing false or inaccurate information; therefore, 68 participants started the study.
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.
Outcome measures
| Measure |
Attention Control Arm
LMH-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.
|
LMH-4-DCP Intervention
n=106 Participants
LMH-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.
|
|---|---|---|
|
The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of Family Caregivers (2) Decline Participation.
|
—
|
0.04 proportion of participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This outcome measure was assessed among caregiver participants only. Of 174 individuals screened, 106 met eligibility criteria and 74 were enrolled. 68 were ineligible because they were not a primary dementia family caregiver (n=39), self-reported a cognitive impairment (n=4), lacked internet access (n=2), the care recipient (CR) was in residential care (n=5), CR had severe dementia (n=10), or CR did not speak English (n=8).
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.
Outcome measures
| Measure |
Attention Control Arm
LMH-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.
|
LMH-4-DCP Intervention
n=174 Participants
LMH-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.
|
|---|---|---|
|
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.
|
—
|
0.39 proportion of participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants only. 27 intervention participants were assessed at follow-up. 6 participants were lost to follow-up and 1 participant withdrew.
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.
Outcome measures
| Measure |
Attention Control Arm
LMH-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.
|
LMH-4-DCP Intervention
n=27 Participants
LMH-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.
|
|---|---|---|
|
The Usability of the LMH-4-DCP Application as Measured by the System Usability Scale (SUS).
|
—
|
73.61 score on a scale
Standard Deviation 6.05
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants assigned to the LMH-4-DCP intervention arm because it intended to evaluate satisfaction and acceptability of the LMH-4-DCP application. Participants in the attention control arm did not receive the reminiscence-based intervention and therefore were not assessed on this outcome. 27 intervention participants completed the acceptability assessment at follow-up; 6 participants were lost to follow-up and 1 participant withdrew.
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.
Outcome measures
| Measure |
Attention Control Arm
LMH-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.
|
LMH-4-DCP Intervention
n=27 Participants
LMH-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.
|
|---|---|---|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Survey That Measures the Participants Satisfaction and Acceptability of the Application.
|
—
|
32.85 score on a scale
Standard Deviation 6.05
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants assigned to the LMH-4-DCP intervention arm because it intended to evaluate satisfaction and acceptability of the LMH-4-DCP application. Participants in the attention control arm did not receive the reminiscence-based intervention and therefore were not assessed on this outcome. 27 intervention participants completed the acceptability assessment at follow-up; 6 participants were lost to follow-up and 1 participant withdrew.
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?"
Outcome measures
| Measure |
Attention Control Arm
LMH-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.
|
LMH-4-DCP Intervention
n=27 Participants
LMH-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.
|
|---|---|---|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Most Valuable Feature: Resources
|
—
|
5 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Most Valuable Feature: Photo-Sharing
|
—
|
6 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
No Suggestions for Improvement
|
—
|
19 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Suggested Improvement: Enhance Audiovisual Features
|
—
|
5 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Suggested Improvement: Functionality
|
—
|
3 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Suggested Improvement: Design Refinements
|
—
|
3 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Overall Positive Experience Using LMH-4-DCP
|
—
|
21 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Overall Negative Experience Using LMH-4-DCP
|
—
|
2 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Overall Neutral Experience Using LMH-4-DCP
|
—
|
4 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Most Valuable Feature: Reminiscence
|
—
|
10 participants
|
|
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
Most Valuable Feature: Journaling
|
—
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants only. 27 participants per group were assessed at follow-up (54 total). 6 intervention \& 5 control participants were lost to follow-up. 1 intervention \& 1 control participant withdrew. 1 control participant no longer met eligibility criteria (lost internet access) during the study period.
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.
Outcome measures
| Measure |
Attention Control Arm
n=27 Participants
LMH-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.
|
LMH-4-DCP Intervention
n=27 Participants
LMH-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.
|
|---|---|---|
|
Change in Grief Severity as Measured by the Pre-Loss Prolonged Grief Revised (PG-12-R) Instrument.
|
0.47 score on a scale
Standard Deviation 8.69
|
-3.29 score on a scale
Standard Deviation 8.64
|
SECONDARY outcome
Timeframe: Baseline, 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants only. 27 participants per group were assessed at follow-up (54 total). 6 intervention \& 5 control participants were lost to follow-up. 1 intervention \& 1 control participant withdrew. 1 control participant no longer met eligibility criteria (lost internet access) during the study period.
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.
Outcome measures
| Measure |
Attention Control Arm
n=27 Participants
LMH-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.
|
LMH-4-DCP Intervention
n=27 Participants
LMH-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.
|
|---|---|---|
|
Change in Relationship Quality as Measured by the Relational Deprivation Scale.
|
-0.11 score on a scale
Standard Deviation 4.66
|
1.69 score on a scale
Standard Deviation 4.92
|
SECONDARY outcome
Timeframe: Baseline, 2 WeeksPopulation: 0 participants were assessed at follow-up and no participant data were available for the outcome measure. Due to a technical issue in survey programming, the Mutuality Scale was inadvertently omitted from the follow-up REDCap assessment. As a result, follow-up mutuality data were not collected from participants in either study arm. The omission was not identified until after completion of data collection, and therefore no analyses could be conducted for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 2 WeeksPopulation: This outcome measure was assessed among enrolled caregiver participants only. 27 participants per group were assessed at follow-up (54 total). 6 intervention \& 5 control participants were lost to follow-up. 1 intervention \& 1 control participant withdrew. 1 control participant no longer met eligibility criteria (lost internet access) during the study period.
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.
Outcome measures
| Measure |
Attention Control Arm
n=27 Participants
LMH-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.
|
LMH-4-DCP Intervention
n=27 Participants
LMH-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.
|
|---|---|---|
|
Change in Relationship Quality as Measured by the Relationship Rewards Scale.
RRS: Pre-Illness
|
-0.74 score on a scale
Standard Deviation 2.65
|
-0.32 score on a scale
Standard Deviation 2.58
|
|
Change in Relationship Quality as Measured by the Relationship Rewards Scale.
RRS: Current Relationship
|
-0.60 score on a scale
Standard Deviation 2.48
|
0.54 score on a scale
Standard Deviation 3.06
|
Adverse Events
LMH-4-DCP Intervention
Attention Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place