Trial Outcomes & Findings for Perceived Social Support, Heart Rate Variability, and Hopelessness in Patients With Ischemic Heart Disease (NCT NCT05003791)

Last Updated: 2024-06-06

Results Overview

The State-Trait Hopelessness Scale (STHS) was used to measure state hopelessness. The STHS uses a Likert-type scale ranging from 1 (strongly disagree) to 4 (strongly agree) and differentiates state and trait hopelessness. For the 10-item state subscale, participants respond to statements based on how they feel "today (right now)." The responses for each subscale are totaled and divided by the number of items in the subscale to provide a final score ranging from one to four, with lower scores indicating lower levels of hopelessness.

Recruitment status

COMPLETED

Target enrollment

48 participants

Primary outcome timeframe

baseline data was obtained two weeks after hospital discharge

Results posted on

2024-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Hope Beats Participants that met the inclusion criteria and screened as experiencing none to mild hopelessness (a score of \< 1.8 on the State-Trait Hopelessness Scale) and were enrolled in the Hope Beats study
Overall Study STARTED	48
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analyzed all participants with appropriate HRV data. These are all the participants with an HRV recording of at least 5 minutes in length with less than 5% artifact corrected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hope Beats n=45 Participants Participants that met the inclusion criteria and screened as experiencing none to mild hopelessness (a score of \< 1.8 on the State-Trait Hopelessness Scale) and were enrolled in the Hope Beats study
Age, Continuous	61.44 years STANDARD_DEVIATION 8.68 • n=45 Participants
Sex: Female, Male Female	15 Participants n=45 Participants
Sex: Female, Male Male	30 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants
Race (NIH/OMB) Asian	0 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	2 Participants n=45 Participants
Race (NIH/OMB) White	43 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants
Region of Enrollment United States	45 Participants n=45 Participants
State Hopelessness Screening	1.25 units on a scale STANDARD_DEVIATION 0.21 • n=45 Participants
Trait Hopelessness	1.41 units on a scale STANDARD_DEVIATION 0.36 • n=45 Participants
Perceived Social Support	23.16 units on a scale STANDARD_DEVIATION 2.92 • n=45 Participants
Depressive Symptom Severity	4.09 units on a scale STANDARD_DEVIATION 3.84 • n=45 Participants
High frequency heart rate variability	4.15 log(ms^2) STANDARD_DEVIATION 1.19 • n=37 Participants • Analyzed all participants with appropriate HRV data. These are all the participants with an HRV recording of at least 5 minutes in length with less than 5% artifact corrected.
RMSSD heart rate variability	2.72 log(ms) STANDARD_DEVIATION 0.63 • n=37 Participants • Analyzed all participants with appropriate HRV data. These are all the participants with an HRV recording of at least 5 minutes in length with less than 5% artifact corrected.
History of depression	13 Participants n=45 Participants
Has insurance	41 Participants n=45 Participants
Married	36 Participants n=45 Participants
Employed	26 Participants n=45 Participants
Completed some college or more schooling	41 Participants n=45 Participants
Had coronary artery bypass graft surgery during hospitalization	24 Participants n=45 Participants
Prescribed a beta-blocker at time of discharge	31 Participants n=37 Participants • Only documented beta-blocker prescription for participants with useable HRV data.

PRIMARY outcome

Timeframe: baseline data was obtained two weeks after hospital discharge

Outcome measures

Outcome measures
Measure	Hope Beats n=45 Participants Participants that met the inclusion criteria and screened as experiencing none to mild hopelessness (a score of \< 1.8 on the State-Trait Hopelessness Scale) and were enrolled in the Hope Beats study
State Hopelessness	1.25 units on a scale Standard Deviation 0.21

PRIMARY outcome

Timeframe: Baseline data was obtained 2 weeks after hospital discharge

Population: All participants with a useable 5 minute short-term HRV recording with less than 5% corrected artifact

Participants completed a short-term heart rate variability (HRV) measurement at rest while laying supine, silent, and still for 10 minutes. From the 10-minute HRV recordings, the 5-minute intermediate segment with the least amount of artifact was used for analysis. Kubios HRV Software was used to analyze the HRV data. Kubios utilizes Fast Fourier Transform to run frequency domain analyses. Artifact were identified and corrected using a threshold-based artifact correction algorithm in Kubios that compares RR intervals against a local average interval. The lowest level threshold thought to detect artifact without overcorrecting normal beats was utilized for each recording. Only recordings with \< 5% artifact were used in the analysis

Outcome measures

Outcome measures
Measure	Hope Beats n=37 Participants Participants that met the inclusion criteria and screened as experiencing none to mild hopelessness (a score of \< 1.8 on the State-Trait Hopelessness Scale) and were enrolled in the Hope Beats study
Log Transformed High Frequency Heart Rate Variability	4.15 log(ms^2) Standard Deviation 1.19

PRIMARY outcome

Timeframe: Baseline data was obtained 2 weeks after hospital discharge

Population: All participants with a useable 5 minute short-term HRV recording with less than 5% corrected artifact.

Participants completed a short-term heart rate variability (HRV) measurement at rest while laying supine, silent, and still for 10 minutes. From the 10-minute HRV recordings, the 5-minute intermediate segment with the least amount of artifact was used for analysis. Kubios HRV Software was used to analyze the HRV data. Artifact were identified and corrected using a threshold-based artifact correction algorithm in Kubios that compares RR intervals against a local average interval. The lowest level threshold thought to detect artifact without overcorrecting normal beats was utilized for each recording. Only recordings with \< 5% artifact were used in the analysis

Outcome measures

Outcome measures
Measure	Hope Beats n=37 Participants Participants that met the inclusion criteria and screened as experiencing none to mild hopelessness (a score of \< 1.8 on the State-Trait Hopelessness Scale) and were enrolled in the Hope Beats study
Log Transformed Root Mean Square of Successive Differences Between Normal Heartbeats	2.72 log(ms) Standard Deviation 0.63

Adverse Events

Hope Beats

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Madison Goodyke

University of Illinois Chicago

Phone: 6166446417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place