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Heart-Focused Breathing in Alzheimer's Disease Caregivers

Arizona State University (ASU) logo

Arizona State University (ASU)

Status

Withdrawn

Conditions

Burnout, Caregiver
Quality of Life

Treatments

Behavioral: Online Heart-Focused Breathing Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04077450
STUDY00009353

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Modified Waitlist Control Arm
No Intervention group
Description:
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.
Intervention Arm
Experimental group
Description:
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.
Treatment:
Behavioral: Online Heart-Focused Breathing Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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