An interventional study of Biofeedback Training and Dementia Education in Stress, Carer Stress Syndrome and Dementia, sponsored by Case Western Reserve University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment
How do different health self-management interventions (resourcefulness training or biofeedback training) compare to usual care (dementia education) in affecting the health risks, and physical and mental health, of family caregivers of people with dementia? And, how do those health outcomes compare with similar measures for family caregivers of people with bipolar disorder? This one-year supplement study will exam these two aims as part of a larger four-year parent grant (NCT03023332). Caregivers enrolled in the study will be randomized to one of the three self-management interventions, with two data collections time points pre- and post-intervention.
With every passing minute, a family member in the United States becomes an informal caregiver for an elder with Alzheimer's disease or another related dementia, which can be highly distressing and adversely affect the caregiver's mental and physical health. Similar to caregivers of persons with bipolar disorder, who are currently participating in the parent study for which this supplement is proposed, caregivers of persons with Alzheimer's or related dementia have been found to experience greater distress than caregivers of persons with other chronic conditions. They have significantly more mental and physical health problems than the general population, leading to greater use of mental health and primary care services and resulting in their inability to continue to provide care for their family members. Thus, although the trajectories of the two conditions (bipolar disorder versus dementia) may differ, we propose that caregivers of persons with dementia may benefit similarly from tailored health self-management interventions, including resourcefulness skills or biofeedback training, more than the educational materials or programs they are typically offered. Therefore, the caregivers of persons with Alzheimer's disease or related dementia to be sampled in this administrative supplement will comprise an additional study arm for the randomized controlled trial constituting the parent study. They will be randomized to: 1) usual care (education program), 2) resourcefulness training, or 3) biofeedback. Three outcomes (health risk, mental health, and physical health) will be assessed at baseline and post-intervention.
Study aims are to:
Repeated measures analyses and descriptive statistics will address the study aims. Our findings will generate new scientific knowledge about the effectiveness of novel, easy to use, independently performed interventions that can be individualized and self-tailored to promote the health of Alzheimer's caregivers and other comparably distressed family caregivers.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's enrollment of 92 is above the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →Case Western Reserve University is the lead sponsor of 161 studies on the registry; 29 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Resourcefulness Training
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.
Other: Dementia Education
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.
Behavioral: 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.
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.
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.
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
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.
Time frame: From T1 (baseline) through T2 (30 days post-intervention)
Change in Health Risk Behavior Scale
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk
Time frame: From T1 (baseline) through T2 (30 days post-intervention)
Change in Dementia Knowledge Assessment Scale
Measure of Dementia Knowledge: 25 items; true-false (5-point scale); Scores range 25-125; higher score indicates better knowledge
Time frame: From T1 (baseline) through T2 (30 days post-intervention)
Change in Heart Rate Variability
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
Time frame: From T1 (baseline) through T2 (30 days post-intervention)
Change in Resourcefulness Scale
Measure of Resourcefulness: 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness
Time frame: From T1 (baseline) through T2 (30 days post-intervention)
| Milestone | Biofeedback Training | Resourcefulness Training | Dementia Education |
|---|---|---|---|
| Started | 28 | 28 | 29 |
| Received intervention | 26 | 27 | 26 |
| Completed | 25 | 24 | 25 |
| Not completed | 3 | 4 | 4 |
| Withdrew: Withdrawal by subject | 2 | 3 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 |
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.
| score on a scale | Biofeedback Training | Resourcefulness Training | Dementia Education |
|---|---|---|---|
| T1: Baseline | 27.23 ± 4.38 | 27.13 ± 4.85 | 27.52 ± 4.32 |
| T2 | 27.23 ± 5.26 | 28.63 ± 4.56 | 28.20 ± 4.80 |
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk
| score on a scale | Biofeedback Training | Resourcefulness Training | Dementia Education |
|---|---|---|---|
| Baseline: Time 1 | 15.9 ± 2.80 | 14.74 ± 3.00 | 14.58 ± 2.16 |
| Time 2 | 14.80 ± 2.82 | 15.33 ± 2.85 | 14.52 ± 2.37 |
Measure of Dementia Knowledge: 25 items; true-false (5-point scale); Scores range 25-125; higher score indicates better knowledge
| score on a scale | Biofeedback Training | Resourcefulness Training | Dementia Education |
|---|---|---|---|
| Baseline: Time 1 | 31.71 ± 8.51 | 28.96 ± 7.59 | 33.52 ± 6.75 |
| Time 2 | 33.04 ± 8.45 | 32.25 ± 6.84 | 36.28 ± 7.44 |
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
| milliseconds | Biofeedback Training | Resourcefulness Training | Dementia Education |
|---|---|---|---|
| T1: Baseline | 70.60 ± 58.43 | 86.67 ± 59.14 | 79.03 ± 55.48 |
| T2: 30 days post-intervention | 55.81 ± 27.22 | 43.85 ± 28.25 | 54.53 ± 33.37 |
Measure of Resourcefulness: 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness
| score on a scale | Biofeedback Training | Resourcefulness Training | Dementia Education |
|---|---|---|---|
| T1: Baseline | 91.81 ± 15.229 | 87.67 ± 16.25 | 97.20 ± 14.85 |
| T2: 30 days post-intervention | 93.81 ± 15.99 | 91.08 ± 13.43 | 95.68 ± 11.79 |
Collected over Data was collected for the duration of the study. Participants completed a baseline questionnaire (T1), a 1 month intervention, and followup questionnaires at 6months (Q2) and 12 months (Q3) post-intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resourcefulness Training | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Dementia Education | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Biofeedback Training | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
All consented participants who completed T1
| Age, Categorical(Participants) | Biofeedback Training | Resourcefulness Training | Dementia Education | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 15 | 15 | 44 |
| >=65 years | 14 | 13 | 14 | 41 |
| Sex: Female, Male(Participants) | Biofeedback Training | Resourcefulness Training | Dementia Education | Total |
|---|---|---|---|---|
| Female | 24 | 25 | 26 | 75 |
| Male | 4 | 3 | 3 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Biofeedback Training | Resourcefulness Training | Dementia Education | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 3 | 5 |
| Not Hispanic or Latino | 27 | 26 | 25 | 78 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Biofeedback Training | Resourcefulness Training | Dementia Education | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 7 | 7 | 23 |
| White | 19 | 19 | 19 | 57 |
| More than one race | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 1 | 2 | 3 |
| Region of Enrollment(participants) | Biofeedback Training | Resourcefulness Training | Dementia Education | Total |
|---|---|---|---|---|
| United States | 28 | 28 | 29 | 85 |
| Global Health(units on a scale) | Biofeedback Training | Resourcefulness Training | Dementia Education | Total |
|---|---|---|---|---|
| Mean | 27.21 ± 4.21 | 26.61 ± 5.26 | 27.24 ± 4.32 | 27.02 ± 4.87 |
| Health Risk Behavior Scale(units on a scale) | Biofeedback Training | Resourcefulness Training | Dementia Education | Total |
|---|---|---|---|---|
| Mean | 16.12 ± 2.93 | 15.30 ± 3.27 | 14.54 ± 2.23 | 15.36 ± 2.98 |
| Heart Rate Variability(milliseconds) | Biofeedback Training | Resourcefulness Training | Dementia Education | Total |
|---|---|---|---|---|
| Mean | 67.09 ± 57.69 | 80.22 ± 57.12 | 73.71 ± 52.95 | 73.74 ± 55.20 |
2 further baseline measures are reported on the registry.
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