- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04498975
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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.
Clinical Trials on Cardiac Disease
-
University of British ColumbiaRecruitingSurgery | Cardiac Event | Cardiac Disease | Cardiac Complication | Cardiac Valve Disease | Surgery-ComplicationsCanada
-
Istituto Auxologico ItalianoRecruitingCardiovascular Diseases | Cardiomyopathies | Ischemic Heart Disease | Sudden Cardiac Death Due to Cardiac ArrhythmiaItaly
-
Tampere Heart HospitalTampere University; Tampere University HospitalRecruitingSudden Cardiac Death | Sudden Cardiac Death Due to Cardiac Arrhythmia | Sudden Cardiac Arrest | Coronary Arterial Disease (CAD) | Acute Coronary EventFinland
-
UMC UtrechtRadboud University Medical Center; University Medical Center Groningen; Amsterdam...RecruitingInherited Cardiac DiseaseNetherlands
-
Ostfold University CollegeNot yet recruitingCardiac Arrest | Cardiac Arrhythmia | Cardiac Disease | Cardiac Death
-
Johns Hopkins UniversityNational Human Genome Research Institute (NHGRI)Active, not recruitingGenetic Counseling | Inherited Cardiac DiseaseUnited States
-
Centro Medico TeknonRecruitingMyocardial Infarction | Ischemic Heart Disease | Ventricular Tachycardia | Magnetic Resonance Imaging | Ventricular Arrythmia | Sudden Cardiac Death | Sudden Cardiac Death Due to Cardiac ArrhythmiaSpain
-
Children's Healthcare of AtlantaTerminated
-
University Hospital of FerraraRecruitingGenetic Disease | Cardiac Disease | Genetic Disorder | Cardiac Arrhythmias | CardiologyItaly
-
Corsano Health B.V.Not yet recruitingCardiac Arrythmias | Valve Heart Disease | Cardiac IschemiaNetherlands