Trial Outcomes & Findings for Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers (NCT NCT04058886)
NCT ID: NCT04058886
Last Updated: 2023-07-19
Results Overview
The instructor will conduct a role call to take attendance at the beginning of each of the 8 class sessions and 1 retreat session. Eighty-five percent of participants who start the intervention will complete at least 6 out of 9 intervention sessions. Attendance used as a proxy to assess intervention acceptability.
COMPLETED
NA
57 participants
8 weeks
2023-07-19
Participant Flow
Primary Caregivers and Care Partners were enrolled as dyads. A total of 28 dyads and 1 additional Primary Caregiver were included in the analysis. One Care Partner was not enrolled as planned after the Primary Caregiver had already been enrolled.
Participant milestones
| Measure |
Telephone-delivered Mindfulness
Participating caregivers and care partners will receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
Telephone-delivered Mindfulness: The telephone-delivered mindfulness training intervention that will incorporate the following elements: 1) training for primary caregivers (CG) and their caregiving partner (CP) in a telephone-based mindfulness training intervention; 2) groups of up to eight participants (four CG-CP pairs) plus an instructor, on a shared telephone line; and 3) training in a 8-week, modified Mindfulness-Based Stress Reduction (MBSR) program, which places additional emphasis on training in the following: a) mindful experiencing, including mindfulness of feelings and body sensations; b) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and c) mindful compassion for self and others. Additionally, homework assignments will involve listening to exercises on a dial-in telephone line; and assignments for CG-CP dyads (e.g. mindful listening and communication practices) as well as CG mindfulness practices in the presence of care recipients (e.g., mindful eating, and mindful listening).
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|---|---|
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Overall Study
STARTED
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57
|
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Overall Study
Primary Caregivers Started
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29
|
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Overall Study
Care Partners Started
|
28
|
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Overall Study
Primary Caregivers Completed
|
27
|
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Overall Study
Care Partners Completed
|
25
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Overall Study
COMPLETED
|
52
|
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
| Measure |
Telephone-delivered Mindfulness
Participating caregivers and care partners will receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
Telephone-delivered Mindfulness: The telephone-delivered mindfulness training intervention that will incorporate the following elements: 1) training for primary caregivers (CG) and their caregiving partner (CP) in a telephone-based mindfulness training intervention; 2) groups of up to eight participants (four CG-CP pairs) plus an instructor, on a shared telephone line; and 3) training in a 8-week, modified Mindfulness-Based Stress Reduction (MBSR) program, which places additional emphasis on training in the following: a) mindful experiencing, including mindfulness of feelings and body sensations; b) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and c) mindful compassion for self and others. Additionally, homework assignments will involve listening to exercises on a dial-in telephone line; and assignments for CG-CP dyads (e.g. mindful listening and communication practices) as well as CG mindfulness practices in the presence of care recipients (e.g., mindful eating, and mindful listening).
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|---|---|
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Overall Study
Withdrawal by Subject
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4
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Overall Study
Inadequate deafness interpreter service
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1
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Baseline Characteristics
Data are reported separately for Primary Caregivers and Care Partners.
Baseline characteristics by cohort
| Measure |
Telephone-delivered Mindfulness
n=57 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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|---|---|
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Age, Continuous
Primary Caregivers
|
61 years
STANDARD_DEVIATION 9 • n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Age, Continuous
Care Partners
|
53 years
STANDARD_DEVIATION 20 • n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Sex: Female, Male
Primary Caregivers · Female
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26 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
|
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Sex: Female, Male
Primary Caregivers · Male
|
3 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
|
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Sex: Female, Male
Care Partners · Female
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19 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Sex: Female, Male
Care Partners · Male
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9 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Ethnicity (NIH/OMB)
Primary Caregivers · Hispanic or Latino
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1 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Ethnicity (NIH/OMB)
Primary Caregivers · Not Hispanic or Latino
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28 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Ethnicity (NIH/OMB)
Primary Caregivers · Unknown or Not Reported
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0 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Ethnicity (NIH/OMB)
Care Partners · Hispanic or Latino
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0 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Ethnicity (NIH/OMB)
Care Partners · Not Hispanic or Latino
|
28 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Ethnicity (NIH/OMB)
Care Partners · Unknown or Not Reported
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0 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Primary Caregivers · American Indian or Alaska Native
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0 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Primary Caregivers · Asian
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0 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Primary Caregivers · Native Hawaiian or Other Pacific Islander
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0 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Primary Caregivers · Black or African American
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29 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Primary Caregivers · White
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0 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Primary Caregivers · More than one race
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0 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Race (NIH/OMB)
Primary Caregivers · Unknown or Not Reported
|
0 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Care Partners · American Indian or Alaska Native
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0 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Race (NIH/OMB)
Care Partners · Asian
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0 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Race (NIH/OMB)
Care Partners · Native Hawaiian or Other Pacific Islander
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0 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Care Partners · Black or African American
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28 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Race (NIH/OMB)
Care Partners · White
|
0 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Race (NIH/OMB)
Care Partners · More than one race
|
0 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Race (NIH/OMB)
Care Partners · Unknown or Not Reported
|
0 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Region of Enrollment
United States
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57 Participants
n=57 Participants
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Highest Education Level Completed
Primary Caregivers · High School or less
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2 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Highest Education Level Completed
Primary Caregivers · Some College
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12 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Highest Education Level Completed
Primary Caregivers · Bachelor's Degree
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10 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Highest Education Level Completed
Primary Caregivers · Advanced Degree
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5 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Highest Education Level Completed
Care Partners · High School or less
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7 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Highest Education Level Completed
Care Partners · Some College
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8 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Highest Education Level Completed
Care Partners · Bachelor's Degree
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9 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Highest Education Level Completed
Care Partners · Advanced Degree
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4 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Number of Participants Working Outside the Home
Primary Caregivers
|
15 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Number of Participants Working Outside the Home
Care Partners
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16 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Annual Household Income
Primary Caregivers · Less than $20K per year
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9 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Annual Household Income
Primary Caregivers · $21-40K per year
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5 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Annual Household Income
Primary Caregivers · $41-60K per year
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6 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Annual Household Income
Primary Caregivers · $61-80K per year
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3 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Annual Household Income
Primary Caregivers · More than $80K per year
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3 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Annual Household Income
Primary Caregivers · Preferred Not to Answer
|
3 Participants
n=29 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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Annual Household Income
Care Partners · Less than $20K per year
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4 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Annual Household Income
Care Partners · $21-40K per year
|
10 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Annual Household Income
Care Partners · $41-60K per year
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4 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Annual Household Income
Care Partners · $61-80K per year
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3 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Annual Household Income
Care Partners · More than $80K per year
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4 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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|
Annual Household Income
Care Partners · Preferred Not to Answer
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3 Participants
n=28 Participants • Data are reported separately for Primary Caregivers and Care Partners.
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PRIMARY outcome
Timeframe: 8 weeksThe instructor will conduct a role call to take attendance at the beginning of each of the 8 class sessions and 1 retreat session. Eighty-five percent of participants who start the intervention will complete at least 6 out of 9 intervention sessions. Attendance used as a proxy to assess intervention acceptability.
Outcome measures
| Measure |
Primary Caregivers
n=29 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=28 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=57 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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|---|---|---|---|
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Number of Participants Attending at Least 6 Telephone Sessions
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27 Participants
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23 Participants
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50 Participants
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PRIMARY outcome
Timeframe: 8 weeksPopulation: Of the 25 dyads completed, 1 Primary Caregiver and 1 Care Partner were unavailable to complete the interview thus eliminating 2 dyads and leaving 23 dyads for this evaluation.
The intervention will be acceptable to informal caregiving teams as evidenced by an 85 percent (95% Confidence Interval (CI): 72.5, 97.5) endorsement of the program in post-participation interviews. Calculated based on responses to open-ended questions regarding participants' experiences of the intervention. Examples of questions are: "how valuable or beneficial was the mindfulness training to you?" and "what challenges did you have with the training?" and "what did you expect from the training that you did not get?". Endorsement was considered positive if the expressions of value outweighed challenges (i.e., positive comments outweighed negative comments by dyad). Data reported as caregiving teams (dyads) in accordance with the protocol.
Outcome measures
| Measure |
Primary Caregivers
n=46 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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Total Population
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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|---|---|---|---|
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Percent of Dyads Who Endorse the Program
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100 percent of dyads
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—
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—
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SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Two Care Partners are missing Baseline data due to an electronic glitch. One Care Partner who completed the intervention was unavailable to complete the post-intervention assessments.
The ZBI-12 is a 12-item (SF) version of the original 29-item questionnaire measures role strain and personal strain. Items are measured on a 5-point Likert scale (0=never to 4=nearly always). Scores range from 0-48 with lower scores representing less burden. Within group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=22 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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Total Population
n=49 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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|---|---|---|---|
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Change From Baseline in the Zarit Burden Interview Short Form (ZBI-12) Score
|
-2.5 score on a scale
Interval -4.5 to -0.5
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-3.6 score on a scale
Interval -6.6 to -0.5
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-2.9 score on a scale
Interval -4.5 to -1.3
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SECONDARY outcome
Timeframe: up to 8 weeksPopulation: One Care Partner who completed the intervention was unavailable to complete the post-intervention assessments and another Care Partner did not complete all of the measures.
The FSS is a 10-item scale which uses a 5-point Likert scale (1=very dissatisfied to 5=extremely satisfied). Total scores range from 10-50 with higher scores representing more endorsement of family satisfaction. The FSS was administered at Baseline and Week 8. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=23 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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Total Population
n=50 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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|---|---|---|---|
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Change From Baseline in the Family Satisfaction Scale (FSS) Score
|
2.78 score on a scale
Interval -0.7 to 6.25
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4.30 score on a scale
Interval 0.46 to 8.15
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3.12 score on a scale
Interval 0.75 to 5.5
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SECONDARY outcome
Timeframe: up to 8 weeksPopulation: One Care Partner who completed the intervention was unavailable to complete the post-intervention assessments.
The prospective anxiety subscale of the Intolerance of Uncertainty Scale (IUS-12) is a 7-item measure. The measure uses a 5-point Likert scale (1=not at all like me to 5=entirely like me). Scores range from 7-35, with lower scores reflecting more tolerance of uncertain situations. IUS-12 was administered at Baseline and at 8 weeks. Change scores are reported from paired t-tests for within-group assessments and from mixed effects models for the total population controlling for caregiving role, severity of dementia in the care recipient and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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|---|---|---|---|
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Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Prospective Subscale Score
|
-1.11 score on a scale
Interval -3.89 to 1.67
|
-1.00 score on a scale
Interval -2.58 to 0.58
|
-1.16 score on a scale
Interval -2.69 to 0.36
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: One Care Partner who completed the intervention was unavailable to complete the post-intervention assessments.
The inhibitory subscale of the Intolerance of Uncertainty Scale (IUS-12) is a 5-item measure. The measure uses a 5-point Likert scale (1=not at all like me to 5=entirely like me). Total scores range from 5-25, with lower scores reflecting more tolerance of uncertain situations. IUS-12 was administered at baseline and at 8 weeks. Within group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
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Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Inhibitory Subscale Score
|
-0.81 score on a scale
Interval -2.22 to 0.59
|
-1.17 score on a scale
Interval -2.47 to 0.14
|
-0.97 score on a scale
Interval -1.87 to -0.09
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Data unavailable for one Care Partner who was unavailable at Week 8 and a Primary Caregiver who did not provide data at either Baseline or Week 8.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose-Short Form 6a is a 6-item scale that assesses a sense that life has purpose and there are good reasons for living, including hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. It uses a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Raw scores range from 6-30 with higher scores representing more endorsement of meaning and life. Raw scores are converted to T-scores based on population norms with a mean of 50 and standard deviation of 10. Therefore a score of 60 represents 1 standard deviation above the population average and indicates a high level of meaning and purpose. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=26 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=50 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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|---|---|---|---|
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Change From Baseline on PROMIS Meaning and Purpose-Short Form 6a
|
3.18 T-score
Interval 0.52 to 5.85
|
2.23 T-score
Interval -0.84 to 5.29
|
2.7 T-score
Interval 0.81 to 4.5
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SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: The CAMS-R was added late and is unavailable at Baseline for the first 7 participants in the study (1st 4 Primary Caregivers, 1st 3 Care Partners). One Primary Caregiver did not complete the measure at Baseline or 8 weeks. One Care Partner who completed the intervention did not complete the measure at 8 weeks.
The CAMS-R is a 12-item scale measuring mindfulness by using language that is not representative of any particular meditation training or practice. It uses a 4-point Likert scale with responses ranging from 1 (Rarely/Not at all) to 4 (Almost always). Total scores range from 12-48. Higher scores indicate higher levels of mindfulness. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=22 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=21 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=43 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
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|---|---|---|---|
|
Change From Baseline on Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
|
2.77 units on a scale
Interval 0.22 to 5.32
|
2.04 units on a scale
Interval -0.22 to 4.31
|
2.5 units on a scale
Interval 0.99 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable to complete the post-intervention assessments.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety-Short Form 4a is a 4-item scale that assesses fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). It uses a 5-point Likert scale (1=never to 5=always). Raw scores range from 4-20 and are standardized to T-scores based on population averages (mean 50 and standard deviation 10). A score less than 55 is within normal limits. A score between 55-59.9 represents mild anxiety. A score greater than 60-69.9 represents moderate anxiety and a score of 70 or greater represents severe anxiety. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on PROMIS Emotional Distress-Anxiety-Short Form 4a
|
-0.9 T-score
Interval -3.86 to 2.01
|
0.06 T-score
Interval -5.1 to 5.23
|
0.67 T-score
Interval -0.18 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the study was unavailable to complete the post-intervention questionnaire.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anger-Short Form 5a item is a 5-item scale that assesses angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. It uses a 5-point Likert scale (1=never to 5=always). Raw scores range from 5-25 and are standardized to T-scores based on population averages (mean 50 and standard deviation 10). A score less than 55 is within normal limits. A score between 55-59.9 represents mild anger; 60-69.9 represents moderate anger and 70 or greater represents severe anger. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on PROMIS Emotional Distress-Anger-Short Form 5a
|
-0.79 T score
Interval -3.89 to 2.3
|
2.21 T score
Interval -2.11 to 6.54
|
0.67 T score
Interval -1.8 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health is a 2-item scale that assesses overall evaluation of one's physical health. It is based on the well-validated Rand measure, assessing general self-rated physical health, physical function, pain, and fatigue. It uses a 5-point Likert scale (1=poor to 5=excellent). Raw scores range from 2-10 and are standardized to T-scores with a population average of 50 and standard deviation of 10. Suggested cut points include 58 or higher = excellent; 50-57.9 = very good; 42-49.9 = good; 35-41.9 = fair, and less than 35 = poor. Change scores are reported from mixed effects models that utilize the entire population.
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on PROMIS Global Physical Health
|
-1.85 T score
Interval -3.69 to -0.01
|
-1.16 T score
Interval -4.26 to 1.95
|
-1.45 T score
Interval -3.07 to 0.17
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable to complete the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form is an 18-item measure consisting of 5 positive coping strategies (acceptance, positive refocusing, planning, positive reappraisal, putting into perspective) and 4 negative strategies (rumination, catastrophizing, self-blame, other-blame). Total scores range from 18-90 with higher scores representing more cognitive emotional regulation. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving roles, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form
|
1.48 score on a scale
Interval -0.82 to 3.78
|
0.88 score on a scale
Interval -2.68 to 4.42
|
1.29 score on a scale
Interval -0.59 to 3.16
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form acceptance subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater acceptance coping. Change scores are reported from mixed effects models controlling for caregiving role, severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Acceptance)
|
0.07 score on a subscale
Interval -1.0 to 1.14
|
-0.46 score on a subscale
Interval -1.81 to 0.89
|
-0.22 score on a subscale
Interval -1.0 to 0.57
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form positive refocusing subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater positive refocusing coping strategy. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving roles, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Positive Refocusing)
|
0.15 score on a subscale
Interval -0.84 to 1.13
|
1.08 score on a subscale
Interval -0.52 to 2.68
|
0.55 score on a subscale
Interval -0.3 to 1.4
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment. Another Care Partner declined to answer this question at Baseline.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form planning subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater planning. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving roles, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=23 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=50 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Planning)
|
0.15 score on a subscale
Interval -0.95 to 1.25
|
-0.57 score on a subscale
Interval -1.49 to 0.36
|
-0.21 score on a subscale
Interval -0.87 to 0.46
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form positive reappraisal subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater positive reappraisal. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving roles, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Positive Reappraisal)
|
0.07 score on a subscale
Interval -0.75 to 0.9
|
0.25 score on a subscale
Interval -0.53 to 1.03
|
0.25 score on a subscale
Interval -0.29 to 0.78
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form putting into perspective subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater putting into perspective coping strategy. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving roles, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Putting Into Perspective)
|
-0.41 score on a subscale
Interval -1.41 to 0.59
|
0.67 score on a subscale
Interval -0.68 to 2.01
|
0.23 score on a subscale
Interval -0.53 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form rumination subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater rumination. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Rumination)
|
-1.0 score on a subscale
Interval -1.87 to -0.13
|
-0.04 score on a subscale
Interval -0.94 to 0.85
|
-0.49 score on a subscale
Interval -1.1 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form catastrophizing subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater catastrophizing coping. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Catastrophizing)
|
-0.37 score on a subscale
Interval -1.12 to 0.38
|
-0.13 score on a subscale
Interval -0.9 to 0.65
|
-0.30 score on a subscale
Interval -0.78 to 0.18
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form self-blame subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater self-blame as a coping strategy. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving roles, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Self-Blame)
|
-0.52 score on a subscale
Interval -1.31 to 0.28
|
0.08 score on a subscale
Interval -0.81 to 0.97
|
-0.30 score on a subscale
Interval -0.85 to 0.25
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessment.
Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form other-blame subscale consisting of two questions. The subscale scores range from 2-10 with higher scores representing greater blaming others as a coping strategy. Change scores are reported from mixed effects models controlling for caregiving role, severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Other-Blame)
|
0.11 score on a subscale
Interval -0.52 to 0.74
|
0.21 score on a subscale
Interval -0.58 to 1.0
|
0.14 score on a subscale
Interval -0.31 to 0.6
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessments and a Primary Caregiver completed only part of the post-intervention assessments.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support-Short Form 4a is a 4-item scale that assesses perceived feelings of being cared for and valued as a person and having confidant relationships. Item responses use a 5-point LIkert scale (1=never to 5=always). Raw scores range from 4-20. The PROMIS Emotional Support item is reported as a T score standardized to a population mean of 50 and standard deviation of 10 with higher scores reflecting more positive endorsement of emotional support. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=26 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=50 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on PROMIS Emotional Support-Short Form 4a
|
0.48 T score
Interval -2.29 to 3.21
|
1.39 T score
Interval -2.43 to 5.21
|
0.89 T score
Interval -1.22 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessments and a Primary Caregiver completed only part of the post-intervention assessments.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support-Short Form 4a is a 4-item scale that assesses perceived availability of helpful information or advice. Item responses use a 5-point LIkert scale (1=never to 5=always). Raw scores range from 4-20. The PROMIS Informational Support item is reported as a T score standardized to a population mean of 50 and standard deviation of 10 with higher scores reflecting more positive endorsement of informational support. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=26 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=50 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on PROMIS Informational Support-Short Form 4a
|
2.72 T score
Interval -0.83 to 6.27
|
2.05 T score
Interval -1.83 to 5.93
|
2.65 T score
Interval 0.23 to 5.07
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessments and a Primary Caregiver completed only part of the post-intervention assessments.
The PROMIS Instrumental Support-Short Form 4a is a 4-item scale that assesses perceived availability of assistance with material, cognitive or task performance. Item responses use a 5-point LIkert scale (1=never to 5=always). Raw scores range from 4-20. The PROMIS Instrumental Support item is reported as a T score standardized to a population mean of 50 and standard deviation of 10 with higher scores reflecting more positive endorsement of instrumental support. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=26 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=50 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on PROMIS Instrumental Support-Short Form 4a
|
0.87 T score
Interval -2.19 to 3.92
|
0.35 T score
Interval -3.61 to 4.31
|
0.65 T score
Interval -1.61 to 2.92
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable to complete the post-intervention assessments.
The Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy-Short Form 4a is a 4-item scale that assesses confidence in ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. Items are measured on a 5-point Likert scale (1=I am not at all confident to 5=I am very confident). Raw scores range from 4-20. The PROMIS General Self-Efficacy item is reported as a T score standardized to a population mean of 50 and standard deviation of 10 with higher scores reflecting more positive endorsement of self-efficacy. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on PROMIS General Self-Efficacy-Short Form 4a
|
2.51 T scores
Interval -1.39 to 6.41
|
1.79 T scores
Interval -0.94 to 4.52
|
2.2 T scores
Interval -0.03 to 4.4
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Three Care Partners who provided no direct care did not complete this measure. One Care Partner who completed the intervention was unavailable to complete the post-intervention assessments. One Primary Caregiver did not complete the measure at Baseline.
The Neuropsychiatric Inventory (NPI-Q) Caregiver Distress subscale uses a 6-point scale with 12 items and scores ranging from 0-60. The NPI-Q measures the degree of distress associated with symptoms associated with dementia e.g., delusions, appetite change, and anxiety. Higher scores indicate more distress. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=26 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=21 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=47 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline in Mean NPI-Q Distress Scores
|
-2.31 units on a scale
Interval -5.6 to 0.99
|
-1.24 units on a scale
Interval -4.41 to 1.94
|
-1.8 units on a scale
Interval -3.9 to 0.29
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for post-intervention assessments.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Emotions-Short Form 4a is a 4-item scale that assesses confidence to manage/control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment and anger. Items are measured using a 5-point Likert scale (1=I am not at all confident to 5=I am very confident). Raw scores range from 4-20. The PROMIS Self-Efficacy for Managing Emotions item is reported as a T score standardized to a population mean of 50 and standard deviation of 10 with higher scores reflecting more positive endorsement of managing emotion. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=24 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=51 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on PROMIS Self-Efficacy for Managing Emotions-Short Form 4a
|
1.96 T score
Interval -0.69 to 4.6
|
-0.06 T score
Interval -3.78 to 3.65
|
0.98 T score
Interval -1.1 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention did not complete the post-intervention assessments and another Care Partner completed only part of the post-intervention assessments.
The FCS is a 12-item scale that measures the degree of conflict the family experiences about the seriousness of the care recipient's condition, concerns about the care recipient's safety, what the care recipient can do for him/herself, and whether a nursing home is indicated. The first subscale measures conflict around definitions of the illness and strategies for care (4 items). Items are measured on a 4-point Likert scale (1=no disagreement to 4=quite a bit of disagreement). The total scores range from 4-16 with lower scores representing less family conflict. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=23 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=50 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline in the Family Conflict Strategies for Care Subscale
|
-0.30 score on a scale
Interval -1.65 to 1.06
|
-0.17 score on a scale
Interval -1.5 to 1.15
|
-0.23 score on a scale
Interval -1.11 to 0.64
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: One Care Partner who completed the intervention was unavailable for the post-intervention assessments and another Care Partner completed only part of the post-intervention assessments.
The FCS is a 12-item scale that measures the degree of conflict the family experiences about the seriousness of the care recipient's condition, concerns about the care recipient's safety, what the care recipient can do for him/herself, and whether a nursing home is indicated. The second subscale measures conflict around family members' attitudes and action toward the patient (4 items) Items are measured on a 4-point Likert scale (1=no disagreement to 4=quite a bit of disagreement). The total scores range from 4-16 with lower scores representing less family conflict. Within-group change scores are reported based on paired t-tests. Total change scores are reported from mixed effects models controlling for caregiving role, the severity of dementia in the care recipient, and dependencies in the data (individuals within families within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=27 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=23 Participants
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
n=50 Participants
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline in the Family Conflict Scale Attitudes and Actions Toward the Patient Subscale
|
-0.30 score on a scale
Interval -1.95 to 1.35
|
-0.43 score on a scale
Interval -1.94 to 1.07
|
-0.34 score on a scale
Interval -1.35 to 0.68
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: This subscale was administered only to the Primary Caregivers. Data was unavailable at follow-up for two Primary Caregivers who completed the intervention.
The FCS is a 12-item scale that measures the degree of conflict the family experiences about the seriousness of the care recipient's condition, concerns about the care recipient's safety, what the care recipient can do for him/herself, and whether a nursing home is indicated. The third subscale measures conflict around family members' actions and attitudes around the caregiver (4 items). Items are measured on a 4-point Likert scale (1=no disagreement to 4=quite a bit of disagreement). The total scores range from 4-16 with lower scores representing less family conflict. This measure was requested from the primary caregiver only. Change scores are reported from mixed effects models controlling for the severity of dementia in the care recipient and dependencies in the data (individuals within cohorts).
Outcome measures
| Measure |
Primary Caregivers
n=25 Participants
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Total Population
Participating Primary Caregivers and Care Partners receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|---|
|
Change From Baseline on Family Conflict Scale (FCS) Actions and Attitudes Toward the Caregiver Subscale
|
-0.06 score on a scale
Interval -1.63 to 1.52
|
—
|
—
|
Adverse Events
Primary Caregivers
Care Partners
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Primary Caregivers
n=29 participants at risk
The primary caregivers providing regular daily care for a family member who has dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
Care Partners
n=28 participants at risk
A secondary informal caregiver who shares caregiving or helps make decisions regarding the person with dementia receive mindfulness training in 8 weekly telephone sessions plus one retreat between weeks 5 and 6.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
3.4%
1/29 • Number of events 1 • During the 8-week intervention period
|
0.00%
0/28 • During the 8-week intervention period
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/29 • During the 8-week intervention period
|
7.1%
2/28 • Number of events 2 • During the 8-week intervention period
|
|
Psychiatric disorders
Emotional Distress
|
3.4%
1/29 • Number of events 1 • During the 8-week intervention period
|
7.1%
2/28 • Number of events 2 • During the 8-week intervention period
|
Additional Information
Kim Faurot, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place