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Heart to Heart Yoga for Caregiver Burden, Heart Failure, Depression, Anxiety, and Stress (H2HYoga Trial)

N/A

Waitlist Available

Led By Jennifer Miller, PhD, RN

Research Sponsored by Jennifer Miller

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

H2HYoga Trial Summary

This trial will assess an intervention program (Heart2Heart) to improve physical and psychological outcomes in patients with heart failure (HF) and their caregivers. 20 patients and 20 caregivers (n=40) will be randomly assigned to the intervention or usual care. After 12-weeks, outcomes will be assessed.

Eligible Conditions

Caregiver Burden
Heart Failure
Depression
Anxiety
Stress

H2HYoga Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety

Brain Derived Neurotrophic Factor

C Reactive Protein

+9 more

H2HYoga Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

A total of 20 patients with HF and 20 caregivers (n= 40) who have at least mild depressive symptoms (Patient Health Questionnaire 9 [PHQ-9] score = 5) will be randomly assigned to the intervention or usual care group stratified by patient and caregiver groups (Figure 1). Only participants in the intervention will be asked to attend the 12-week sessions (two sessions per week; a total of 24 sessions in 12 weeks) via video conferencing (i.e., ZOOM). The short-term intervention efficacy will be assessed at the following week of the completion of 12-weeks sessions. Primary psychological outcomes include depressive symptoms, anxiety, stress, and quality of life. Primary physical outcomes include physical activity level, sleep quality, and perceived symptoms.

Group II: Usual CareActive Control1 Intervention

Participants in the usual care group will also receive the printed information and links to the AHA's Life's Simple 7 program without explicit skills and training, including education and stress management. We will encourage stress management by watching and practicing yoga programs by providing a yoga mat.

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Who is running the clinical trial?

Jennifer MillerLead Sponsor

1 Previous Clinical Trials

60 Total Patients Enrolled

Misook L. ChungLead Sponsor

2 Previous Clinical Trials

345 Total Patients Enrolled

Jennifer Miller, PhD, RNPrincipal InvestigatorUniversity of Kentucky

Media Library

Caregiver Burden Research Study Groups: Intervention, Usual Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial limited to individuals aged 35 or younger?

"The age requirements for this trial are 18 as the lower limit and 99 as the upper bound."

Answered by AI

What type of individuals are best suited to engage in this experiment?

"Patients with heart failure aged 18-99 are eligible to partake in this medical trial, of which 40 participants will be selected."

Answered by AI

Are there any vacancies in this trial for individuals who are seeking care?

"Yes, clinicaltrials.gov data confirms that this medical study - initially posted on October 15th 2022 - is actively recruiting patients with the aim of enrolling 40 people from a single site."

Answered by AI

What is the current capacity for enrollment in this trial?

"Affirmative, the clinicaltrial.gov registry demonstrates that this medical trial is presently enrolling participants. Initially published on October 15th 2022 and most recently revised March 9th 2023, 40 patients are currently being sought at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of the Heart to Heart Yoga Program

Misook L. Chung 2022. "Feasibility of the Heart to Heart Yoga Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05778747.