Heart-Focused Breathing in Alzheimer's Disease Caregivers

NCT ID: NCT04077450

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2020-01-27

Brief Summary

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This research study will explore the effects of an online heart-focused breathing intervention on 20 informal caregivers of patients with Alzheimer's Disease (AD) over a period of two weeks.

Detailed Description

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Informal caregivers are often live-in, unpaid spouses, relatives, partners, or friends that help with a loved one's activities of daily living. As a result of caring for a person with Alzheimer's Disease (AD), many informal caregivers experience caregiver burden. The demanding physical, emotional, and financial responsibilities to care for an AD patient can be detrimental to the caregiver's health.

A group of 20 men and women who consider themselves the primary caregiver of a person with AD will be recruited and enrolled into the study. Participants will be randomized into one of two study arms, (a) the modified-waitlist control arm or (b) the intervention arm. The study will explore the effects of an online heart-focused breathing intervention on heart rate variability (measured by the Welltory app on their smart device), perceived burden, stress, and quality of life in the intervention arm over a two-week period.

Conditions

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Burnout, Caregiver Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial in which participants will be randomized into (a) the modified waitlist-control arm or (b) the intervention arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Only participants will be blinded as to which study arm he or she was assigned.

Study Groups

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Modified Waitlist Control Arm

Participants will complete the following components of baseline (T1) data collection: demographics, questionnaire, heart rate variability assessment. Two weeks later, participants will be asked to complete post-intervention data collection (T2), which consists of a questionnaire and heart rate variability assessment. After the completion of data collection, participants will be offered the online heart-focused breathing intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

Participants will complete the following components of baseline (T1) data collection: demographics, questionnaire, heart rate variability assessment. These participants will receive an online heart-focused breathing intervention. Participants will be asked to practice their breathing skills while monitoring their heart rate variability using the Welltory app on their smart device for the following two weeks. Participants will be instructed to maintain a log to record the date and time of each practice session. Research staff will make biweekly reminder calls to participants. After the two-week period, participants will complete post-intervention data collection (T2), which includes a questionnaire and HRV assessment.

Group Type EXPERIMENTAL

Online Heart-Focused Breathing Intervention

Intervention Type BEHAVIORAL

Participants will receive an online standardized HeartMath© heart-focused breathing intervention.

Interventions

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Online Heart-Focused Breathing Intervention

Participants will receive an online standardized HeartMath© heart-focused breathing intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male or female
* 18 years of age or older
* Live-in and unpaid informal caregiver to a loved one with Alzheimer's Disease
* Provides care or supervision for at least 4 hours per day for more than 6 months
* Experiencing stress

Exclusion Criteria

* Caregivers who report a low risk assessment score and/or report a medically diagnosed arrhythmia or have a pacemaker will be excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona State University

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00009353

Identifier Type: -

Identifier Source: org_study_id

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