Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients

May 17, 2021 updated by: Dordt University
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.

Study Overview

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Avera Health
      • Sioux Falls, South Dakota, United States, 57108
        • Sanford Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized individuals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with IHD
No intervention
Observational study exploring rurality, ethnicity, exercise and hopelessness patterns cross-sectionally and longitudinally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Six-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nathan Tintle, Dordt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hopelessness-Rurality

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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