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OpenTrials
Completed

NCT Number: NCT04498975

Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients

Hopelessness is associated with 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. Low levels of PA independently contribute to increased death and adverse events in patients with IHD. Rates of PA in IHD patients continue to be unacceptably low in both hospital-based cardiac rehabilitation and home settings. Compounding this issue is often the symptom of hopelessness. The links among hopelessness, PA and mortality and morbidity for patients with IHD remain largely unknown, especially in rural and minority IHD patients. The purpose of this study is to delineate differences in hopelessness between urban and rural patients with IHD, as well as between racial minority, including Hispanic and Native American, and White patients with IHD. Potential mediation of urbanicity and race/ethnicity by social connectedness, a key variable in rural settings, will also be examined. A 6-month longitudinal study will be conducted at Sanford Heart Hospital and Avera Health in Sioux Falls, South Dakota. Hopelessness will be measured using the State-Trait Hopelessness Scale. The results of this study have potential to transform nursing practice by providing a better understanding of hopelessness in IHD patients and informing future exercise rehabilitation studies and interventions in rural and minority populations.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Avera Health, Sioux Falls, South Dakota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myocardial infarction or unstable angina or having undergone a percutaneous coronary intervention or coronary artery bypass surgery
  • ≥ 18 years
  • planned discharge home
  • cognitive and physical ability to complete the study measures.

Exclusion criteria

  • None

Treatment and study plan

Rurality; Ethnicity; Exercise; Hopelessness

Other

Observational study exploring rurality, ethnicity, exercise and hopelessness patterns cross-sectionally and longitudinally

Primary outcomes

  1. State and Trait levels of Hopelessness

    Time frame: Six-month

    State-Trait Hopelessness Scale (values range from 1-4 on both subscales with larger values meaning more hopelessness)

Secondary outcomes

  1. Participation (yes/no) and Levels (frequency; vigor) of Exercise

    Time frame: Six-month

    CREPT measurement tool for self-reported home and hospital exercise participation (yes/no) and levels (frequency/vigor) of exercise

Sponsors and collaborators

Lead sponsor

Dordt University

Other

Collaborators

  • Avera McKennan Hospital & University Health Center
  • Sanford Health
  • University of Illinois at Chicago

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2020
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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