Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04247347

Enrollment

Registered

2020-01-30

Start date

2019-08-29

Completion date

2022-06-21

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Carer Stress Syndrome, Dementia, Stress

Keywords

Caregiver, Biofeedback, Resourcefulness, Self-Management

Brief summary

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.

Detailed description

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: 1. Examine the effectiveness of resourcefulness training and biofeedback versus usual care (education program) in family caregivers of persons with Alzheimer's disease or related dementia; 2. Compare the effects of usual care, resourcefulness training, and biofeedback obtained in caregivers of persons with dementia with those of the caregivers of persons with bipolar disorder from the parent study; and 3. Explore differences between the two types of caregivers on their needs (determined by their lowest baseline cut score on measures of knowledge, resourcefulness, and heart rate variability) and preferences (determined by asking which intervention they would have chosen) among education, resourcefulness training, or biofeedback. 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.

Interventions

BEHAVIORALBiofeedback 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.

OTHERDementia 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.

BEHAVIORALResourcefulness 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* At least 18 years old * Have a living family member with Alzheimer's disease or another dementia * Identify self as a primary caregiver * In-home caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care for at least the last 6 months. Caregivers whose family member lives within a facility: must report visiting their care recipient at least once per week for at least the last 6 months. * Be capable of performing informed consent and participating in study procedures

Exclusion criteria

* Does not have family member with Alzheimer's disease or another dementia * Has not cared for a living family member for at least the last 6 months. * Has knowledge of another family member in the same household enrolled in the study * Currently pregnant * Has a pacemaker * Lives outside of the study area

Design outcomes

Primary

Measure	Time frame	Description
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)	From T1 (baseline) through T2 (30 days post-intervention)	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.
Change in Health Risk Behavior Scale	From T1 (baseline) through T2 (30 days post-intervention)	Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk

Secondary

Measure	Time frame	Description
Change in Dementia Knowledge Assessment Scale	From T1 (baseline) through T2 (30 days post-intervention)	Measure of Dementia Knowledge: 25 items; true-false (5-point scale); Scores range 25-125; higher score indicates better knowledge
Change in Heart Rate Variability	From T1 (baseline) through T2 (30 days post-intervention)	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
Change in Resourcefulness Scale	From T1 (baseline) through T2 (30 days post-intervention)	Measure of Resourcefulness: 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness

Countries

United States

Participant flow

Pre-assignment details

92 participants completed the informed consent process, however, 7 participants withdrew prior to the randomization process and are, consequently, excluded from the numbers below.

Participants by arm

Arm	Count
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.	28
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.	28
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.	29
Total	85

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	1	1	1
Overall Study	Withdrawal by Subject	2	3	3

Baseline characteristics

Characteristic	Biofeedback Training	Resourcefulness Training	Dementia Education	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	14 Participants	13 Participants	14 Participants	41 Participants
Age, Categorical Between 18 and 65 years	14 Participants	15 Participants	15 Participants	44 Participants
Dementia Knowledge Scale	31.21 units on a scale STANDARD_DEVIATION 8.44	29.18 units on a scale STANDARD_DEVIATION 8.04	32.34 units on a scale STANDARD_DEVIATION 7.4	30.87 units on a scale STANDARD_DEVIATION 7.96
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	2 Participants	3 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants	26 Participants	25 Participants	78 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants	2 Participants
Global Health	27.21 units on a scale STANDARD_DEVIATION 4.21	26.61 units on a scale STANDARD_DEVIATION 5.26	27.24 units on a scale STANDARD_DEVIATION 4.32	27.02 units on a scale STANDARD_DEVIATION 4.87
Health Risk Behavior Scale	16.12 units on a scale STANDARD_DEVIATION 2.93	15.30 units on a scale STANDARD_DEVIATION 3.27	14.54 units on a scale STANDARD_DEVIATION 2.23	15.36 units on a scale STANDARD_DEVIATION 2.98
Heart Rate Variability	67.09 milliseconds STANDARD_DEVIATION 57.69	80.22 milliseconds STANDARD_DEVIATION 57.12	73.71 milliseconds STANDARD_DEVIATION 52.95	73.74 milliseconds STANDARD_DEVIATION 55.2
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	9 Participants	7 Participants	7 Participants	23 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	2 Participants	3 Participants
Race (NIH/OMB) White	19 Participants	19 Participants	19 Participants	57 Participants
Region of Enrollment United States	28 participants	28 participants	29 participants	85 participants
Resourcefulness	92.89 units on a scale STANDARD_DEVIATION 15.7	88.29 units on a scale STANDARD_DEVIATION 15.25	97.57 units on a scale STANDARD_DEVIATION 14.72	92.71 units on a scale STANDARD_DEVIATION 55.2
Sex: Female, Male Female	24 Participants	25 Participants	26 Participants	75 Participants
Sex: Female, Male Male	4 Participants	3 Participants	3 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 28	0 / 28	0 / 29
other Total, other adverse events	0 / 28	0 / 28	0 / 29
serious Total, serious adverse events	0 / 28	0 / 28	0 / 29

Outcome results

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.