Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients

Mental Health Issue Clinical Trial

Official title:

Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498975
• Other study ID #: Hopelessness-Rurality
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: May 2021
• Source: Dordt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Mental Health Issue

Intervention

Other:
• Rurality; Ethnicity; Exercise; Hopelessness
Observational study exploring rurality, ethnicity, exercise and hopelessness patterns cross-sectionally and longitudinally

Locations

Country	Name	City	State
United States	Avera Health	Sioux Falls	South Dakota
United States	Sanford Health	Sioux Falls	South Dakota

Sponsors (4)

Lead Sponsor	Collaborator
Dordt University	Avera McKennan Hospital & University Health Center, Sanford Health, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State and Trait levels of Hopelessness	State-Trait Hopelessness Scale (values range from 1-4 on both subscales with larger values meaning more hopelessness)	Six-month
Secondary	Participation (yes/no) and Levels (frequency; vigor) of Exercise	CREPT measurement tool for self-reported home and hospital exercise participation (yes/no) and levels (frequency/vigor) of exercise	Six-month