Heart-Focused Breathing in Alzheimer's Disease Caregivers

NCT04077450 | Withdrawn

• 1 other identifier: STUDY00009353
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burnout, Caregiver; Quality of Life

Keywords

Stress; Caregiver Burden; Alzheimer's Disease Caregiver; Informal Caregiver; Anxiety; Heart-Focused Breathing

Outcome Measures

Primary Outcomes (1)

• Caregiver Burden

  Caregiver Burden will be measured by the Zarit Burden Interview short version (12 items, 5-point Likert scale; 0= never, 4= nearly always). Score range= 0 to 48. A score of 17 or higher indicates a high level of burden.

  2 weeks

Secondary Outcomes (2)

• Life Quality

  2 weeks

• Perceived Stress

  2 weeks

Study Arms (2)

Modified Waitlist Control Arm

NO INTERVENTION

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

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.

Behavioral: Online Heart-Focused Breathing Intervention

Interventions

Online Heart-Focused Breathing Intervention BEHAVIORAL

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• Caregivers who report a low risk assessment score and/or report a medically diagnosed arrhythmia or have a pacemaker will be excluded

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants will be blinded as to which study arm he or she was assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial in which participants will be randomized into (a) the modified waitlist-control arm or (b) the intervention arm.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: September 4, 2019
• Study Start: January 28, 2019
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)