Heart FailurePRO-HFNCT04264845
Patient-Reported Outcomes as an Indicator of Disease Transitions in Heart Failure
An observational study of Heart Failure, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
This is a prospective, observational, open study that will utilize the following tools: survey/questionnaire research, interviews, and focus groups, and secondary/archival data analysis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Provider Focus, Patient Interview and PROs/Clinical Data Integration
- How many people
- 1,033 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 31 May 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All heart failure providers at the Intermountain Medical Center are potential participants in the Provider Focus Group. Patients with heart failure who are seen in the HF outpatient clinics at Intermountain Medical Center are potential participants in the Patient Interview Group or the PROs/Clinical Data Integration Group.
Who may be able to join
- Eligible participants in the Provider Focus Group and Patient Interview Group:
- Male or female > 18 years of age
- Ability to understand and provide agreement to participation, which must be obtained prior to initiation of any study procedures
- Willing and able to comply with the protocol requirements and schedule of evaluations
- The Provider Focus Group must meet the following additional criteria:
- Heart failure providers, including cardiologists, cardiothoracic surgeons, physician assistants, nurse practitioners, nurses, and medical assistants.
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- They are members of the University of Utah and/or Intermountain Medical Center Heart Failure Teams.
- The Patient Interview Group must meet the following additional criteria:
- Documentation of heart failure with reduced ejection fraction (<50%) or heart failure with preserved ejection fraction (>50%)
- The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah
- Ability to complete PROs, including the KCCQ12 and PROMIS
- Ability to complete a telephone interview
- The PROs/Clinical Data Integration Group must meet the following criteria:
- Male or female > 18 years of age
- Documentation of heart failure with reduced ejection fraction (<50%) or heart failure with preserved ejection fraction (>50%)
- The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah
- No other inclusion criteria are required for this group because study-required information will be obtained from electronic medical records and will not require direct patient contact.
- A subset of subjects in this third group (PROs/Clinical Data Integration Group) will be invited to provide a blood sample for the purpose of examining the biological determinants of patient health status in HF, provided they meet the following criteria:
- Age > 18
- Documentation of heart failure with reduced ejection fraction (<50%) or heart failure with preserved ejection fraction (>50%)
- The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah
- The patient has no contraindications for blood draws
Who cannot join
- Provider Focus Group:
- The provider is not interested or is unable to participate in the focus group
- The Principal Investigator determines that the provider is not eligible for this research study
- Patient Interview Group:
- The patient is not willing to be interviewed
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
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- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial
- The Principal Investigator determines that the proposed patient is not eligible for this research study
- PROs/Clinical Data Integration Group:
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
- Other conditions that in the opinion of the Principal Investigator may compromise the quality of the clinical trial
- The Principal Investigator determines that the proposed patient is not eligible for this research study
- A subset of subjects in this third group (PROs/Clinical Data Integration Group) will be invited to provide a blood sample for the purpose of examining the biological determinants of patient health status in HF, except the following:
- Patients who are not interested in providing blood samples
- Patients without heart failure
- Patients with contraindications to blood draws
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, observational, open study that will utilize the following tools: survey/questionnaire research, interviews, and focus groups, and secondary/archival data analysis. In addition, a subset of selected subjects will be asked to provide blood samples to examine the biologic determinants of patient health status in heart failure (HF). This will help us understand better the biomarkers or genetic factors that may cause differences in patient quality of life.
Read the detailed description
The primary endpoint of this study is the determination of the feasibility and efficiency of integrating routine PRO assessments into the clinical care of patients treated for HF. To reach this, three groups will be involved in the study.
Provider Focus Group (n = 40):
Following obtaining their agreement to participate, the Providers will be given a date, time, and venue for his/her participation in the focus group and will meet for one hour. An agenda and script for the conduct of the focus group session will be developed by a trained moderator. The focus groups will be conducted by a member of the research team. Data from the focus group sessions will be analyzed and used to evaluate clinicians' interpretation of patient-reported outcomes (PROs) and acceptability of PRO data in routine clinical care. A formal provider training program will be designed and implemented by a subject matter expert. The focus group session will be repeated at 12 months, with the 12 month administration having an increased emphasis on barriers, facilitators, and value of PROs in clinical care.
Patient Interview Group (n = 100):
Following obtaining agreement to be interviewed, a trained professional interviewer will conduct a one-time, one-hour, semi-structured telephone interview of each subject to better understand patient experiences with HF, the treatment process and quality of life determinants. Two semistructured interviews will be conducted with the first 30 patients who have had left ventricular assist device (LVAD) therapy (of the 100 patients who agreed to be interviewed), before and 12 months after device implantation. The goal of these interviews will be to describe patient experiences with LVAD therapy, examine factors influencing quality of life, and determine whether currently available PRO tools are likely to capture the intended experiences in HF as they relate to LVAD therapy.
PROs/Clinical Data Integration Group (n = 3500):
The patients' electronic medical records will be reviewed and protocol-required information will be obtained. PRO capture will be expanded in a large population of patients across the continuum of HF patients. A plan has been developed that will integrate PRO scores into their medical records. Information will be obtained from 2 instruments (Kansas City Cardiomyopathy Questionnaire (KCCQ12) and NIH Patient Reported Outcomes Measurement Information System (PROMIS)) that are routinely administered as part standard of care. PRO and clinical data will be obtained from electronic medical records of patients seen in the heart failure clinic during the study period. Patient information will be stored in a secure research database. The data will be used to build prognostic models of 1-year survival with favorable quality of life in patients with various forms of heart failure.
No follow-up visits will be required for the PROs/Clinical Data Integration Group. All protocol-required information will be obtained from the subjects' electronic medical records over a period of 3.5 years after enrollment into the study.
Biologic Determinants of Patient Health Status in HF (n = 1000):
Subjects in the Integration Group that meet the inclusion criteria for this subject subset will be contacted in person by the Principal Investigator or his/her delegate. Subjects will be asked if they are willing to provide their blood samples.
Blood samples will be obtained approximately every six months for the duration of the study (i.e., about 4 years). Approximately 40 ml (or 2.71 tablespoons) of venous blood will be obtained on each scheduled blood draw.
- Conditions
- Heart Failure
- Being tested
- Provider Focus, Patient Interview, PROs/Clinical Data Integration
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider FocusOther
The provider focus groups will be conducted and data from the focus group sessions will be analyzed and used to evaluate clinicians' interpretation of PROs and acceptability of PRO data in routine clinical care. A formal provider training program will be designed and implemented by a subject matter expert. The focus group session will be repeated at 12 months, with the 12month administration having an increased emphasis on barriers, facilitators, and value of PROs in clinical care.
Patient InterviewOther
A trained professional interviewer will conduct a one-time, one-hour, semi-structured telephone interview of each subject to better understand patient experiences with HF, the treatment process and quality of life determinants. Two semistructured interviews will be conducted with the first 30 patients who have had LVAD therapy (of the 100 patients who agreed to be interviewed), before and 12 months after device implantation. The goal of these interviews will be to describe patient experiences with LVAD therapy, examine factors influencing quality of life, and determine whether currently available PRO tools are likely to capture the intended experiences in HF as they relate to LVAD therapy.
PROs/Clinical Data IntegrationOther
A plan has been developed that will integrate PRO scores into patient medical records. Information will be obtained from 2 instruments (KCCQ12 and NIH PROMIS) that are routinely administered as part standard of care. PRO and clinical data will be obtained from electronic medical records of patients seen in the heart failure clinic. All required information will be obtained from the subjects' electronic medical records over a period of 3.5 years after enrollment into the study.
| Study group | Role | What they receive |
|---|---|---|
| Provider Focus Group | All heart failure providers at the participating centers will be screened as potential participants. Receives: Other: Provider Focus | |
| Patient Interview Group | Patients with heart failure who are seen in the heart failure outpatient clinics at the participating centers will be screened for this study. The Principal Investigator will confirm the presence of heart failure based on established and agreed criteria. A real world, diverse population ranging from patients with milder forms of HF to the most advanced disease will be included in this study and allow the researchers to validate the prognostic models in larger, regionally diverse populations to better define the comparative effectiveness of alternative treatments in patients with different risk profiles. Receives: Other: Patient Interview | |
| PROs/Clinical Data Integration Group | Patients with heart failure who are seen in the heart failure outpatient clinics at the participating centers will be screened for this study. The Principal Investigator will confirm the presence of heart failure based on established and agreed criteria. A real world, diverse population ranging from patients with milder forms of HF to the most advanced disease will be included in this study and allow the researchers to validate the prognostic models in larger, regionally diverse populations to better define the comparative effectiveness of alternative treatments in patients with different risk profiles.
This group includes a sub-study of patients providing blood samples. Receives: Other: PROs/Clinical Data Integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time necessary for PRO completion by patients
It is believed that data entry requirement below 10 minutes is conducive to patient participation and will not interfere with clinic flow. This will me monitored throughout the trial.
Measured: 4 years
Completion rate among eligible patients
PRO completion rate will be closely monitored throughout the study. It is anticipated that the completion rate will exceed 80% and will be sustainable over time.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Dec 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 1,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdallah G Kfoury, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264845
- Sponsor's protocol ID
- 1050750
- Acronym
- PRO-HF
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2020
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes as an Indicator of Disease Transitions in Heart Failure
- ClinicalTrials.gov ID
- NCT04264845
- Acronym / sponsor ID
- PRO-HF / 1050750
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,033 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 11 Feb 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.
This is a prospective, observational, open study that will utilize the following tools: survey/questionnaire research, interviews, and focus groups, and secondary/archival data analysis. In addition, a subset of selected subjects will be asked to provide blood samples to examine the biologic determinants of patient health status in heart failure (HF). This will help us understand better the biomarkers or genetic factors that may cause differences in patient quality of life.
Detailed description
The primary endpoint of this study is the determination of the feasibility and efficiency of integrating routine PRO assessments into the clinical care of patients treated for HF. To reach this, three groups will be involved in the study.
Provider Focus Group (n = 40):
Following obtaining their agreement to participate, the Providers will be given a date, time, and venue for his/her participation in the focus group and will meet for one hour. An agenda and script for the conduct of the focus group session will be developed by a trained moderator. The focus groups will be conducted by a member of the research team. Data from the focus group sessions will be analyzed and used to evaluate clinicians' interpretation of patient-reported outcomes (PROs) and acceptability of PRO data in routine clinical care. A formal provider training program will be designed and implemented by a subject matter expert. The focus group session will be repeated at 12 months, with the 12 month administration having an increased emphasis on barriers, facilitators, and value of PROs in clinical care.
Patient Interview Group (n = 100):
Following obtaining agreement to be interviewed, a trained professional interviewer will conduct a one-time, one-hour, semi-structured telephone interview of each subject to better understand patient experiences with HF, the treatment process and quality of life determinants. Two semistructured interviews will be conducted with the first 30 patients who have had left ventricular assist device (LVAD) therapy (of the 100 patients who agreed to be interviewed), before and 12 months after device implantation. The goal of these interviews will be to describe patient experiences with LVAD therapy, examine factors influencing quality of life, and determine whether currently available PRO tools are likely to capture the intended experiences in HF as they relate to LVAD therapy.
PROs/Clinical Data Integration Group (n = 3500):
The patients' electronic medical records will be reviewed and protocol-required information will be obtained. PRO capture will be expanded in a large population of patients across the continuum of HF patients. A plan has been developed that will integrate PRO scores into their medical records. Information will be obtained from 2 instruments (Kansas City Cardiomyopathy Questionnaire (KCCQ12) and NIH Patient Reported Outcomes Measurement Information System (PROMIS)) that are routinely administered as part standard of care. PRO and clinical data will be obtained from electronic medical records of patients seen in the heart failure clinic during the study period. Patient information will be stored in a secure research database. The data will be used to build prognostic models of 1-year survival with favorable quality of life in patients with various forms of heart failure.
No follow-up visits will be required for the PROs/Clinical Data Integration Group. All protocol-required information will be obtained from the subjects' electronic medical records over a period of 3.5 years after enrollment into the study.
Biologic Determinants of Patient Health Status in HF (n = 1000):
Subjects in the Integration Group that meet the inclusion criteria for this subject subset will be contacted in person by the Principal Investigator or his/her delegate. Subjects will be asked if they are willing to provide their blood samples.
Blood samples will be obtained approximately every six months for the duration of the study (i.e., about 4 years). Approximately 40 ml (or 2.71 tablespoons) of venous blood will be obtained on each scheduled blood draw.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Provider Focus Group | – | Other: Provider FocusAll heart failure providers at the participating centers will be screened as potential participants. |
| Patient Interview Group | – | Other: Patient InterviewPatients with heart failure who are seen in the heart failure outpatient clinics at the participating centers will be screened for this study. The Principal Investigator will confirm the presence of heart failure based on established and agreed criteria. A real world, diverse population ranging from patients with milder forms of HF to the most advanced disease will be included in this study and allow the researchers to validate the prognostic models in larger, regionally diverse populations to better define the comparative effectiveness of alternative treatments in patients with different risk profiles. |
| PROs/Clinical Data Integration Group | – | Other: PROs/Clinical Data IntegrationPatients with heart failure who are seen in the heart failure outpatient clinics at the participating centers will be screened for this study. The Principal Investigator will confirm the presence of heart failure based on established and agreed criteria. A real world, diverse population ranging from patients with milder forms of HF to the most advanced disease will be included in this study and allow the researchers to validate the prognostic models in larger, regionally diverse populations to better define the comparative effectiveness of alternative treatments in patients with different risk profiles. This group includes a sub-study of patients providing blood samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All heart failure providers at the Intermountain Medical Center are potential participants in the Provider Focus Group. Patients with heart failure who are seen in the HF outpatient clinics at Intermountain Medical Center are potential participants in the Patient Interview Group or the PROs/Clinical Data Integration Group.
Key inclusion criteria (22 listed)
- Male or female > 18 years of age
- Ability to understand and provide agreement to participation, which must be obtained prior to initiation of any study procedures
- Willing and able to comply with the protocol requirements and schedule of evaluations
- Heart failure providers, including cardiologists, cardiothoracic surgeons, physician assistants, nurse practitioners, nurses, and medical assistants.
- They are members of the University of Utah and/or Intermountain Medical Center Heart Failure Teams.
Key exclusion criteria (16 listed)
- The provider is not interested or is unable to participate in the focus group
- The Principal Investigator determines that the provider is not eligible for this research study
- The patient is not willing to be interviewed
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial
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 |
|---|---|---|
| Provider FocusThe provider focus groups will be conducted and data from the focus group sessions will be analyzed and used to evaluate clinicians' interpretation of PROs and acceptability of PRO data in routine clinical care. A formal provider training program will be designed and implemented by a subject matter expert. The focus group session will be repeated at 12 months, with the 12month administration having an increased emphasis on barriers, facilitators, and value of PROs in clinical care. | Other | Provider Focus Group |
| Patient InterviewA trained professional interviewer will conduct a one-time, one-hour, semi-structured telephone interview of each subject to better understand patient experiences with HF, the treatment process and quality of life determinants. Two semistructured interviews will be conducted with the first 30 patients who have had LVAD therapy (of the 100 patients who agreed to be interviewed), before and 12 months after device implantation. The goal of these interviews will be to describe patient experiences with LVAD therapy, examine factors influencing quality of life, and determine whether currently available PRO tools are likely to capture the intended experiences in HF as they relate to LVAD therapy. | Other | Patient Interview Group |
| PROs/Clinical Data IntegrationA plan has been developed that will integrate PRO scores into patient medical records. Information will be obtained from 2 instruments (KCCQ12 and NIH PROMIS) that are routinely administered as part standard of care. PRO and clinical data will be obtained from electronic medical records of patients seen in the heart failure clinic. All required information will be obtained from the subjects' electronic medical records over a period of 3.5 years after enrollment into the study. | Other | PROs/Clinical Data Integration Group |
Primary outcome
Time necessary for PRO completion by patients
Time frame: 4 years
It is believed that data entry requirement below 10 minutes is conducive to patient participation and will not interfere with clinic flow. This will me monitored throughout the trial.
Completion rate among eligible patients
Time frame: 4 years
PRO completion rate will be closely monitored throughout the study. It is anticipated that the completion rate will exceed 80% and will be sustainable over time.
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 14 Apr 2026.
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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.
Abdallah G Kfoury, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Intermountain Health Care, Inc. at 1 site 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 22 inclusion and 16 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time necessary for PRO completion by patients (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.