Trial Outcomes & Findings for Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention (NCT NCT03593070)
NCT ID: NCT03593070
Last Updated: 2024-10-08
Results Overview
Marwit-Meuser Caregiver Grief Inventory (MM-CGI). Scores range from 50 to 250; higher scores represent higher levels of grief.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
CGMI-V
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
|
Overall Study
COMPLETED
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
CGMI-V
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Overall Study
administrative withdrawal
|
1
|
1
|
Baseline Characteristics
Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention
Baseline characteristics by cohort
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Marwit Meuser Caregiver Grief Inventory (MM-CGI)
|
152.16 units on a scale
STANDARD_DEVIATION 29.90 • n=5 Participants
|
164.46 units on a scale
STANDARD_DEVIATION 34.27 • n=7 Participants
|
158.24 units on a scale
STANDARD_DEVIATION 32.56 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.Population: Study data for 97 participants were analyzed, to determine the mean difference in CGMI-V scores from baseline to 24 weeks. The CGMI-V group was analyzed on an intent to treat (ITT) basis. At baseline, 49 participants were assigned to the CGMI-V group, of whom 44 provided data at Week 8 and 47 provided data at week 24. At baseline, 48 participants were assigned to the MT condition, of whom 45 provided data at Week 8 and 43 provided data at week 24.
Marwit-Meuser Caregiver Grief Inventory (MM-CGI). Scores range from 50 to 250; higher scores represent higher levels of grief.
Outcome measures
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Marwit-Meuser Caregiver Grief Inventory (MM-CGI)
|
12.75 units on a scale
Standard Deviation 9.01
|
11.04 units on a scale
Standard Deviation 7.81
|
SECONDARY outcome
Timeframe: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.Center for Epidemiological Studies Depression Scale (CES-D). The CES-D was assessed with 20-items, where responses are based on a four-point frequency rating (0 = rarely or none of the time to 3 = all of the time), with a possible range of 0 to 60. Larger scores represent more depressive symptoms, lower scores represent fewer symptoms.
Outcome measures
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Change in Depressive Symptoms
|
6.45 units on a scale
Standard Deviation 4.56
|
0.87 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.State-Trait Anxiety Inventory (STAI) was used to represent anxiety symptoms. The (STAI) includes 20 questions, with responses based on a scale of 1 to 4 (1 = almost never to 4 = almost always). Numeric responses to these questions are summed to produce an inventory score, with a possible range of 20-80, where higher scores indicate greater anxiety, and lower scores indicate less anxiety.
Outcome measures
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Change in Anxiety Symptoms
|
5.77 units on a scale
Standard Deviation 4.08
|
0.86 units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.Positive States of Mind Scale (PSOMS) was used to assess the extent to which caregivers were able to achieve six positive states of mind in the previous seven days. PSOM is based on 6 questions that are scored 0-4 and which are summed to produce scale scores that range from 0-24. Lower scores represent difficulty achieving positive states of mind in the past 7 days, higher scores indicate less difficulty achieving positive states of mind.
Outcome measures
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Change in Positive States of Mind
|
1.60 units on a scale
Standard Deviation 1.13
|
0.11 units on a scale
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.Conflict with facility staff was assessed with a subscale of 10 questions collected in the Family Perception of Caregiving Role (FPCR) tool. Scores on these 10 questions ranged from 1 (strongly disagree) to 7 (strongly agree). Response values associated with conflict subscale items were summed to produce total conflict scores ranging from 10-70. Lower scores indicate less conflict with facility staff, higher scores indicate more conflict with facility staff.
Outcome measures
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Change in Conflict With Facility Staff
|
3.83 units on a scale
Standard Deviation 2.71
|
3.75 units on a scale
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.The Family Perception of Care Tool (FPCT) is comprised of 51 questions with 7-point likert-type responses where 1=strongly agree and 7=strongly disagree. When summed to create a total FPCT score, values ranged from 51-357. Higher scores in the FPCT represent more positive feelings towards staff whereas lower scores represent more negative feelings.
Outcome measures
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Change in Satisfaction With Care
|
2.98 units on a scale
Standard Deviation 2.11
|
9.73 units on a scale
Standard Deviation 6.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.Family Knowledge of Alzheimer's Tool (FKAT) captures what a family caregiver knows about the disease process, how the care recipient is behaving, and how the long-term care facility (LTCF) is caring for him or her. Responses are based on a true/false scale, with scores ranging from 0 to 22 correct answers; larger scores indicate greater knowledge about AD, lower scores indicate less knowledge about AD.
Outcome measures
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Change in Knowledge of Alzheimer's Disease
|
0.29 units on a scale
Standard Deviation 0.21
|
0.39 units on a scale
Standard Deviation 0.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.The Revised Family Perceptions of Caregiving Role (FPCR) instrument includes subscales for Loss, Guilt, Role Captivity, and Conflict. Using revised subscales for Loss (7 items), Guilt (5 items), and Role Captivity (7 items), a total score for each subscale was calculated by summing numerical responses to the related questions. The scale ranges were: Loss (7-49), Guilt (5-35), Role Captivity (7-49). Each of the subscales (Sense of Loss, Guilt, and Role Captivity) were then summed to provide a Total score for FPCR, scores of which ranged from 19-133. For each of the subscales and the Total, higher scores represent more negative perceptions of the Caregiving Role, lower scores represent improved perceptions of the Caregiving Role.
Outcome measures
| Measure |
CGMI-V
n=49 Participants
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
|
Minimal Treatment (MT)
n=48 Participants
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
|
|---|---|---|
|
Change in Caregiver Sense of Loss, Guilt, and Role Captivity
|
3.84 units on a scale
Standard Deviation 2.72
|
4.58 units on a scale
Standard Deviation 3.24
|
Adverse Events
CGMI-V
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Minimal Treatment (MT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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