Trial Outcomes & Findings for Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia (NCT NCT04247347)
NCT ID: NCT04247347
Last Updated: 2024-09-19
Results Overview
Measure of Caregiver's Global Health: 5 items - physical health; 5 items - mental health; 5-point scale; Scores range 0-40; higher score indicates better health.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
From T1 (baseline) through T2 (30 days post-intervention)
Results posted on
2024-09-19
Participant Flow
92 participants completed the informed consent process, however, 7 participants withdrew prior to the randomization process and are, consequently, excluded from the numbers below.
Participant milestones
| Measure |
Biofeedback Training
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Resourcefulness Training
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
|
Dementia Education
Dementia Education: An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
29
|
|
Overall Study
Received Intervention
|
26
|
27
|
26
|
|
Overall Study
COMPLETED
|
25
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
Reasons for withdrawal
| Measure |
Biofeedback Training
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Resourcefulness Training
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
|
Dementia Education
Dementia Education: An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
Baseline Characteristics
Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
Baseline characteristics by cohort
| Measure |
Biofeedback Training
n=28 Participants
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Resourcefulness Training
n=28 Participants
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
|
Dementia Education
n=29 Participants
Dementia Education: An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
29 participants
n=5 Participants
|
85 participants
n=4 Participants
|
|
Global Health
|
27.21 units on a scale
STANDARD_DEVIATION 4.21 • n=5 Participants
|
26.61 units on a scale
STANDARD_DEVIATION 5.26 • n=7 Participants
|
27.24 units on a scale
STANDARD_DEVIATION 4.32 • n=5 Participants
|
27.02 units on a scale
STANDARD_DEVIATION 4.87 • n=4 Participants
|
|
Health Risk Behavior Scale
|
16.12 units on a scale
STANDARD_DEVIATION 2.93 • n=5 Participants
|
15.30 units on a scale
STANDARD_DEVIATION 3.27 • n=7 Participants
|
14.54 units on a scale
STANDARD_DEVIATION 2.23 • n=5 Participants
|
15.36 units on a scale
STANDARD_DEVIATION 2.98 • n=4 Participants
|
|
Heart Rate Variability
|
67.09 milliseconds
STANDARD_DEVIATION 57.69 • n=5 Participants
|
80.22 milliseconds
STANDARD_DEVIATION 57.12 • n=7 Participants
|
73.71 milliseconds
STANDARD_DEVIATION 52.95 • n=5 Participants
|
73.74 milliseconds
STANDARD_DEVIATION 55.20 • n=4 Participants
|
|
Resourcefulness
|
92.89 units on a scale
STANDARD_DEVIATION 15.7 • n=5 Participants
|
88.29 units on a scale
STANDARD_DEVIATION 15.25 • n=7 Participants
|
97.57 units on a scale
STANDARD_DEVIATION 14.72 • n=5 Participants
|
92.71 units on a scale
STANDARD_DEVIATION 55.20 • n=4 Participants
|
|
Dementia Knowledge Scale
|
31.21 units on a scale
STANDARD_DEVIATION 8.44 • n=5 Participants
|
29.18 units on a scale
STANDARD_DEVIATION 8.04 • n=7 Participants
|
32.34 units on a scale
STANDARD_DEVIATION 7.40 • n=5 Participants
|
30.87 units on a scale
STANDARD_DEVIATION 7.96 • n=4 Participants
|
PRIMARY outcome
Timeframe: From T1 (baseline) through T2 (30 days post-intervention)Population: All participants who completed both T1 and T2 questionnaires.
Measure of Caregiver's Global Health: 5 items - physical health; 5 items - mental health; 5-point scale; Scores range 0-40; higher score indicates better health.
Outcome measures
| Measure |
Biofeedback Training
n=26 Participants
Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Resourcefulness Training
n=24 Participants
A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
|
Dementia Education
n=25 Participants
An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
Dementia Education: An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
|
|---|---|---|---|
|
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
T1: Baseline
|
27.23 score on a scale
Standard Deviation 4.38
|
27.13 score on a scale
Standard Deviation 4.85
|
27.52 score on a scale
Standard Deviation 4.32
|
|
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
T2
|
27.23 score on a scale
Standard Deviation 5.26
|
28.63 score on a scale
Standard Deviation 4.56
|
28.20 score on a scale
Standard Deviation 4.80
|
PRIMARY outcome
Timeframe: From T1 (baseline) through T2 (30 days post-intervention)Population: Includes all participants who completed both T1 and T2.
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk
Outcome measures
| Measure |
Biofeedback Training
n=26 Participants
Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Resourcefulness Training
n=24 Participants
A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
|
Dementia Education
n=25 Participants
An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
Dementia Education: An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
|
|---|---|---|---|
|
Change in Health Risk Behavior Scale
Time 2
|
14.80 score on a scale
Standard Deviation 2.82
|
15.33 score on a scale
Standard Deviation 2.85
|
14.52 score on a scale
Standard Deviation 2.37
|
|
Change in Health Risk Behavior Scale
Baseline: Time 1
|
15.9 score on a scale
Standard Deviation 2.80
|
14.74 score on a scale
Standard Deviation 3.00
|
14.58 score on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: From T1 (baseline) through T2 (30 days post-intervention)Population: All participants who completed both T1 and T2
Measure of Dementia Knowledge: 25 items; true-false (5-point scale); Scores range 25-125; higher score indicates better knowledge
Outcome measures
| Measure |
Biofeedback Training
n=26 Participants
Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Resourcefulness Training
n=24 Participants
A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
|
Dementia Education
n=25 Participants
An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
Dementia Education: An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
|
|---|---|---|---|
|
Change in Dementia Knowledge Assessment Scale
Baseline: Time 1
|
31.71 score on a scale
Standard Deviation 8.51
|
28.96 score on a scale
Standard Deviation 7.59
|
33.52 score on a scale
Standard Deviation 6.75
|
|
Change in Dementia Knowledge Assessment Scale
Time 2
|
33.04 score on a scale
Standard Deviation 8.45
|
32.25 score on a scale
Standard Deviation 6.84
|
36.28 score on a scale
Standard Deviation 7.44
|
SECONDARY outcome
Timeframe: From T1 (baseline) through T2 (30 days post-intervention)Population: All participants who completed both T1 and T2
HRV is a physiological measure of the healthy functioning of the heart. It is a well-established biomarker for detecting stress. HRV was measured using the BioRadio portable limb-lead electrocardiogram recorder. A sensor was placed on the radial area of the caregiver's forearm for 5 minutes; they were asked to remain still as possible to prevent artifacts in the readings. The data obtained via this device was analyzed with compatible VivoSense software, which automatically computed 8 HRV parameters. One of these was the SDNN score, which is the recognized and most commonly used gold standard biomarker indicative of stress. The SDNN score is the standard deviation of all normal to normal R-R intervals between heartbeats and reported in milliseconds. The SDNN was the outcome of interest for our study as a physiological indicator of stress. For each caregiver, the software produced an average score for the 5-minute measurement
Outcome measures
| Measure |
Biofeedback Training
n=26 Participants
Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Resourcefulness Training
n=23 Participants
A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
|
Dementia Education
n=25 Participants
An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
Dementia Education: An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
|
|---|---|---|---|
|
Change in Heart Rate Variability
T1: Baseline
|
70.60 milliseconds
Standard Deviation 58.43
|
86.67 milliseconds
Standard Deviation 59.14
|
79.03 milliseconds
Standard Deviation 55.48
|
|
Change in Heart Rate Variability
T2: 30 days post-intervention
|
55.81 milliseconds
Standard Deviation 27.22
|
43.85 milliseconds
Standard Deviation 28.25
|
54.53 milliseconds
Standard Deviation 33.37
|
SECONDARY outcome
Timeframe: From T1 (baseline) through T2 (30 days post-intervention)Population: All participants who completed both T1 and T2
Measure of Resourcefulness: 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness
Outcome measures
| Measure |
Biofeedback Training
n=26 Participants
Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Resourcefulness Training
n=24 Participants
A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
|
Dementia Education
n=25 Participants
An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
Dementia Education: An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
|
|---|---|---|---|
|
Change in Resourcefulness Scale
T1: Baseline
|
91.81 score on a scale
Standard Deviation 15.229
|
87.67 score on a scale
Standard Deviation 16.25
|
97.20 score on a scale
Standard Deviation 14.85
|
|
Change in Resourcefulness Scale
T2: 30 days post-intervention
|
93.81 score on a scale
Standard Deviation 15.99
|
91.08 score on a scale
Standard Deviation 13.43
|
95.68 score on a scale
Standard Deviation 11.79
|
Adverse Events
Resourcefulness Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dementia Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biofeedback Training
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
Jaclene Zauszniewski, PhD
Case Western Reserve University
Phone: 216.368.3612
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place