Heart-Focused Breathing in Alzheimer's Disease Caregivers

Sponsor

Arizona State University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04077450

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Burnout, Caregiver Quality of Life	Behavioral: Online Heart-Focused Breathing Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

Only participants will be blinded as to which study arm he or she was assigned.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 28, 2019

Actual Primary Completion Date :

Jan 27, 2020

Actual Study Completion Date :

Jan 27, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Caregiver Burden [2 weeks]
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 [2 weeks]
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 [2 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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