Perceived Social Support, Heart Rate Variability, and Hopelessness in Patients With Ischemic Heart Disease

NCT05003791 | Completed Results

• 2 other identifiers: 2021-0544F31NR019714
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease is the leading cause of death worldwide, with ischemic heart disease (IHD) the leading cause of cardiovascular mortality. Persons with IHD suffering from psychological distress, including hopelessness, are more likely to die from IHD. Following a stressful event, the vagus nerve enables activation of either a sympathetic (fight/flight) or parasympathetic (rest/digest) response. Heart rate variability (HRV), the beat-to-beat variability between normal successive heart beats, is a biomarker of both adaptive and maladaptive reactions to stress. Decreased HRV predicts greater risk for morbidity and mortality and is associated with poor mental health outcomes in persons with IHD. As stated by polyvagal theory, HRV may be influenced by social support. Decreased perceived social support (PSS), a social determinant of cardiovascular risk, is predictive of increased morbidity and mortality in persons with IHD. Decreased PSS has been associated with hopelessness in patients with cancer, but this relationship has not been studied in IHD beyond the applicant's small pilot study of patients with hopelessness. Hopelessness, a negative outlook and sense of helplessness about the future, is present in 27-52% of patients with IHD. This is of grave concern, because hopelessness is associated with a 3.4 times increased risk of mortality and nonfatal myocardial infarction in patients with IHD, independent of depression. This research focuses on understanding the biological (HRV) and social (PSS) aspects of hopelessness, with the long-term goal of developing and testing novel interventions to reduce the adverse effects of hopelessness and improve health outcomes in patients with IHD. Participants for this cross-sectional study will be recruited while hospitalized for an IHD event. Participants will include patients who report moderate to severe hopelessness from the sponsor's NIH-funded study (n = 225); additional patients with minimal to no hopelessness will be recruited and enrolled by the applicant (n = 45). Data collection will take place remotely two weeks after hospital discharge. Specific aims include: Aim 1) Evaluate the relationship between HRV and hopelessness in patients with IHD; Aim 2) Determine the relationship between PSS and hopelessness in patients with IHD; and Aim 3) Explore the possible mediating effect of HRV on the relationship between PSS and hopelessness in patients with IHD.

Conditions

Ischemic Heart Disease

Keywords

heart rate variability; hopelessness; perceived social support

Outcome Measures

Primary Outcomes (3)

• State Hopelessness

  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.

  baseline data was obtained two weeks after hospital discharge

• Log Transformed High Frequency Heart Rate Variability

  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

  Baseline data was obtained 2 weeks after hospital discharge

• Log Transformed Root Mean Square of Successive Differences Between Normal Heartbeats

  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

  Baseline data was obtained 2 weeks after hospital discharge

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be collected 2 weeks after hospital discharge for an IHD event. Patients who provide written-informed consent and enroll will be sent a package with study materials to their home and complete a phone visit 2 weeks after hospital discharge. Recruitment and enrollment of all patients will take place during patients' hospitalization for an IHD event at a large teaching hospital in the Midwestern United States.

You may qualify if:

• Adults ≥ 18 years old; diagnosed with myocardial infarction, unstable angina, or undergoing percutaneous coronary intervention or coronary artery bypass graft surgery; and speak and read English.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Nursing Research (NINR): collaborator
• Sigma Theta Tau International: collaborator

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (2)

• Goodyke MP, Tintle N, Collins E, DeVon HA, Bronas UG, Baynard T, Dunn SL. Lower Perceived Social Support Associated With Greater Hopelessness in Patients After an Acute Ischemic Heart Disease Event. J Cardiovasc Nurs. 2025 Sep-Oct 01;40(5):E239-E247. doi: 10.1097/JCN.0000000000001163. Epub 2024 Oct 24.

  PMID: 39454079 DERIVED

• Goodyke MP, Bronas UG, Baynard T, Tintle N, DeVon HA, Collins E, Dunn SL. Relationships Among Heart Rate Variability, Perceived Social Support, and Hopelessness in Adults With Ischemic Heart Disease. J Am Heart Assoc. 2024 Feb 20;13(4):e032759. doi: 10.1161/JAHA.123.032759. Epub 2024 Feb 13.

  PMID: 38348815 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Madison Goodyke
• Organization: University of Illinois Chicago

mbuurs2@uic.edu

6166446417

Study Officials

• Madison Goodyke

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 12, 2021
• Study Start: September 1, 2021
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Locations

US (1)