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Heart-Focused Breathing in Alzheimer's Disease Caregivers

Primary Purpose

Burnout, Caregiver, Quality of Life

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Heart-Focused Breathing Intervention
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burnout, Caregiver focused on measuring Stress, Caregiver Burden, Alzheimer's Disease Caregiver, Informal Caregiver, Anxiety, Heart-Focused Breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Modified Waitlist Control Arm

Intervention Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 2, 2019
Last Updated
February 21, 2020
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT04077450
Brief Title
Heart-Focused Breathing in Alzheimer's Disease Caregivers
Official Title
Effectiveness of Heart-focused Breathing on Reducing Burden in Alzheimer's Caregivers: An Online Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Changed the direction and aims of the study
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
January 27, 2020 (Actual)
Study Completion Date
January 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Caregiver, Quality of Life
Keywords
Stress, Caregiver Burden, Alzheimer's Disease Caregiver, Informal Caregiver, Anxiety, Heart-Focused Breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial in which participants will be randomized into (a) the modified waitlist-control arm or (b) the intervention arm.
Masking
Participant
Masking Description
Only participants will be blinded as to which study arm he or she was assigned.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Waitlist Control Arm
Arm Type
No Intervention
Arm 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.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Online Heart-Focused Breathing Intervention
Intervention Description
Participants will receive an online standardized HeartMath© heart-focused breathing intervention.
Primary Outcome Measure Information:
Title
Caregiver Burden
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Life Quality
Description
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.
Time Frame
2 weeks
Title
Perceived Stress
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Heart-Focused Breathing in Alzheimer's Disease Caregivers

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