Heart-Focused Breathing in Alzheimer's Disease Caregivers

Effectiveness of Heart-focused Breathing on Reducing Burden in Alzheimer's Caregivers: An Online Randomized Pilot Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Quality of Life; Burnout, Caregiver
• Intervention / Treatment: Behavioral: Online Heart-Focused Breathing Intervention

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
EXPERIMENTAL: 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.	Behavioral: Online Heart-Focused Breathing Intervention; Participants will receive an online standardized HeartMath© heart-focused breathing intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Quality	Quality of Life will be measured by the Arizona Integrative Outcomes Scale (AIOS) (2-items, visual analogue scale; 0 millimeters= worst you have ever been, 100 millimeters= best you have ever been). Score range= 0 to 200. The AIOS asks participants to reflect on their sense of well-being over the past 24 hours and over the past month.	2 weeks
Perceived Stress	Perceived Stress will be measured by the Perceived Stress Scale (PSS) (10 items, 5-point Likert scale; 0= never, 4= very often). Score range= 0 to 40. The PSS has a general score by combining all item scores and reverse scoring items 4, 5, 7, and 8. The PSS has two subscales, one for perceived distress (items 1, 2, 3, 6, 9, 10) and one for perceived coping (4, 5, 7, 8). A higher general score is associated with a higher level of stress.	2 weeks

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 28, 2019
• Primary Completion (ACTUAL): January 27, 2020
• Study Completion (ACTUAL): January 27, 2020

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (ACTUAL): September 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Anxiety; Stress; Caregiver Burden; Informal Caregiver; Alzheimer's Disease Caregiver; Heart-Focused Breathing
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Stress, Psychological; Respiratory Aspiration; Caregiver Burden
• Other Study ID Numbers: STUDY00009353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No