Cardiac DiseaseNCT04498975
Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients
An observational study of Cardiac Disease and Mental Health Issue, run by Dordt University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Disease, Mental Health Issue
- What is being tested?
- Rurality; Ethnicity; Exercise; Hopelessness
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized individuals
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Avera Health
Sioux Falls, South Dakota, 57108
Sanford Health
Sioux Falls, South Dakota, 57108
About this study
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.
- Conditions
- Cardiac Disease, Mental Health Issue
- Being tested
- Rurality; Ethnicity; Exercise; Hopelessness
- Keywords
- Rurality
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rurality; Ethnicity; Exercise; HopelessnessOther
Observational study exploring rurality, ethnicity, exercise and hopelessness patterns cross-sectionally and longitudinally
| Study group | Role | What they receive |
|---|---|---|
| Patients with IHD | No intervention Receives: Other: Rurality; Ethnicity; Exercise; Hopelessness |
What is being measured
The primary outcome is the main question the study is designed to answer.
State and Trait levels of Hopelessness
State-Trait Hopelessness Scale (values range from 1-4 on both subscales with larger values meaning more hopelessness)
Measured: Six-month
Secondary outcomes (1)
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
Measured: Six-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jun 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dordt University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanford Health, Avera McKennan Hospital & University Health Center, University of Illinois Chicago
- Responsible party
- Sponsor
- Investigators
- Nathan Tintle, Principal investigator, Dordt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498975
- Sponsor's protocol ID
- Hopelessness-Rurality
- Status last verified
- May 2021
- First submitted
- 28 Jul 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34465185
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients
- ClinicalTrials.gov ID
- NCT04498975
- Acronym / sponsor ID
- Hopelessness-Rurality
- Conditions
- Cardiac Disease, Mental Health Issue
- Keywords
- Rurality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Dordt UniversityUniversity, hospital or other
- Collaborators
- Sanford Health, Avera McKennan Hospital & University Health Center, University of Illinois Chicago
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IHD | – | Other: Rurality; Ethnicity; Exercise; HopelessnessNo intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized individuals
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rurality; Ethnicity; Exercise; HopelessnessObservational study exploring rurality, ethnicity, exercise and hopelessness patterns cross-sectionally and longitudinally | Other | Patients with IHD |
Primary outcome
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)
1 secondary outcome
Participation (yes/no) and Levels (frequency; vigor) of Exercise
Time frame: Six-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 34465185Bomgaars 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Tintle principal investigator
Dordt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Mental Health Issue, run by Dordt University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State and Trait levels of Hopelessness (time frame: Six-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.