Heart-Focused Breathing in Alzheimer's Disease Caregivers

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04077450
• Other study ID #: STUDY00009353
• Status: Withdrawn
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: January 27, 2020

Study information

• Verified date: February 2020
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 27, 2020
• Est. primary completion date: January 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Caregiver
• Burnout, Psychological
• Quality of Life
• Respiratory Aspiration

Intervention

Behavioral:
• Online Heart-Focused Breathing Intervention
Participants will receive an online standardized HeartMath© heart-focused breathing intervention.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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