NCT04498975

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

2.2 years

First QC Date

July 28, 2020

Last Update Submit

May 17, 2021

Conditions

Keywords

Rurality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Six-month

Study Arms (1)

Patients with IHD

No intervention

Other: Rurality; Ethnicity; Exercise; Hopelessness

Interventions

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

Patients with IHD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized individuals

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Avera Health

Sioux Falls, South Dakota, 57108, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57108, United States

Location

Related Publications (1)

  • Bomgaars D, Jensen GA, White LL, Van De Griend KM, Visser AK, Goodyke MP, Luong A, Tintle NL, Dunn SL. Investigating Rurality as a Risk Factor for State and Trait Hopelessness in Hospitalized Patients With Ischemic Heart Disease. J Am Heart Assoc. 2021 Sep 7;10(17):e020768. doi: 10.1161/JAHA.121.020768. Epub 2021 Sep 1.

MeSH Terms

Conditions

Heart Diseases

Interventions

EthnicityExercise

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nathan Tintle

    Dordt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 5, 2020

Study Start

June 1, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations