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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resourcefulness Training | Experimental | 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. |
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| Dementia Education | Active Comparator | 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. |
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| Biofeedback Training | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | From T1 (baseline) through T2 (30 days post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From T1 (baseline) through T2 (30 days post-intervention) |
| Change in Heart Rate Variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaclene A Zauszniewski, PhD | Case Western Reserve University - Frances Payne Bolton School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
92 participants completed the informed consent process, however, 7 participants withdrew prior to the randomization process and are, consequently, excluded from the numbers below.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2021 |
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| Dementia Education | Other | 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. |
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| Resourcefulness Training | Behavioral | 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. |
|
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 |
| 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 | From T1 (baseline) through T2 (30 days post-intervention) |
| FG001 | 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. |
| FG002 | 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. |
| Received Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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All consented participants who completed T1
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Global Health | Measure Description: Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) scale. 5 items - physical health; 5 items - mental health; 5-point scale; Scores range 0-40; higher scores indicate better health. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Health Risk Behavior Scale | Health risks were measured using the Change in Health Risk Behavior Scale. The scale consists of 9 items measured on a 3-point scale, Scores range 9-27; higher score indicates greater risk | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. Data obtained via this device was analyzed with compatible VivoSense software, which automatically computed 8 HRV parameters, including the SDNN score. The SDNN score is the standard deviation of all normal to normal R-R intervals between heartbeats and reported in milliseconds. | Mean | Standard Deviation | milliseconds |
| ||||||||||||||
| Resourcefulness | Resourcefulness scale score. Composite item comprising of responses to 28 items scored on a 6 point likert scale. Scores range from 0-140, with higher scores indicating greater resourcefulness. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Dementia Knowledge Scale | Measure of Dementia Knowledge: 25 items; true-false (5-point scale); Scores range 25-125; higher score indicates better knowledge | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who completed both T1 and T2 questionnaires. | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) through T2 (30 days post-intervention) |
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| Primary | 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 | Includes all participants who completed both T1 and T2. | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) through T2 (30 days post-intervention) |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who completed both T1 and T2 | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) through T2 (30 days post-intervention) |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who completed both T1 and T2 | Posted | Mean | Standard Deviation | milliseconds | From T1 (baseline) through T2 (30 days post-intervention) |
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| Secondary | Change in Resourcefulness Scale | Measure of Resourcefulness: 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness | All participants who completed both T1 and T2 | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) through T2 (30 days post-intervention) |
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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.
All events would have been reported. No adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG001 | 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. 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. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | 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. 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaclene Zauszniewski, PhD | Case Western Reserve University | 216.368.3612 | jaz@case.edu |
| Apr 19, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 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. |
| OG002 | 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. |
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