A Cardiac Disease Quality of Life Study (UPLIFT)

August 4, 2023 updated by: Milind Desai, The Cleveland Clinic

A Prospective Study to Assess Multi-Domain Patient-Reported Cardiac Quality of Life in Adults With Hypertrophic Cardiomyopathy, Thoracic Aortopathy, and Radiation-Induced Heart Disease: UPLIFT

A prospective, longitudinal, non-comparator, non-randomized observational cohort study to assess the quality of life in adult patients affected by hypertrophic cardiomyopathy and thoracic aortic dilatations who are not amenable to surgery, as well as those affected radiation-induced cardiac disease caused by radiation therapy.

Study Overview

Detailed Description

While physicians and patients may be aware of the physical limitations that result from a diagnosis of hypertrophic cardiomyopathy (HCM), thoracic aortic dilatation (TAD) or radiation-induced heart disease (RIHD), there is little research on the impact on quality of life from the limitations imposed with these diagnosis. This study aims to address these unknowns in patients with HCM or TAD as well as radiation-induced heart disease in first-time patients at the Cleveland Clinic. Knowledge gained from this study will provide us the ability for better management of the chronic impacts of the disease by identifying potential risk factors of low quality of life or changes in quality of life over time.

This is a prospective, longitudinal, non-comparator, non-randomized survey study describing QOL outcomes for patients with HCM, TAD, or RIHD. Patients being seen for the first time at the Cleveland Clinic for cardiac disease with no previous or scheduled surgery for HCM or TAD will electronically complete a Cardiac Quality of Life Survey at 3 time points (baseline, 3 month & 9 month). The Cardiac Quality of Life Survey measures the participant's health status in five domains - global, physical, emotional, social, and spiritual - as well as self-efficacy and resilience.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Milind Desai, M. D.
  • Phone Number: 216-445-5250
  • Email: desaim2@ccf.org

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study will include first-time patients being seen at the Cleveland Clinic whose information will be collected in-person and remotely.

Description

Inclusion Criteria:

  • Patients aged 18-70 at time of consent with a confirmed diagnosis of HCM, TAD, and/or RIHD being seen at CC Main Campus for a comprehensive clinical cardiac evaluation (i.e. physician, surgeon, nurse practitioner, geneticist, testing, imaging, etc) to define treatment plan for either diagnosis as per Cleveland Clinic provider.
  • Patient or an individual in their social support network has the equipment (phone, computer, tablet) and internet connection to complete the emailed follow-up questionnaires.

Exclusion Criteria:

  • Previously had surgery or plans to have surgery (full/mini sternotomy or endovascular) in the next nine months for HCM or TAD.
  • Inability or unwillingness to comply with study requirements in the opinion of the investigator.
  • Inability to provide informed consent.

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
Hypertrophic Cardiomyopathy
Patients being seen for the first time at the Cleveland Clinic for Hypertrophic Cardiomyopathy.
The Cardiac Quality of Life (QOL) survey measures health status in five domains: global, physical, emotional, social, and spiritual health. It also includes questions that assess self-efficacy and resilience. The global section asks about your overall quality of life and satisfaction with health. The physical section asks about symptoms and difficulty performing day-to-day tasks. The emotional section asks about depression, anxiety, and stress. The social section asks about social support and relationships. The spiritual section asks about the spiritual outlook on the burden of heart disease. Responses on a 5-level scale.
Thoracic Aortic Dilatation
Patients being seen for the first time at the Cleveland Clinic for Thoracic Aortic Dilatation.
The Cardiac Quality of Life (QOL) survey measures health status in five domains: global, physical, emotional, social, and spiritual health. It also includes questions that assess self-efficacy and resilience. The global section asks about your overall quality of life and satisfaction with health. The physical section asks about symptoms and difficulty performing day-to-day tasks. The emotional section asks about depression, anxiety, and stress. The social section asks about social support and relationships. The spiritual section asks about the spiritual outlook on the burden of heart disease. Responses on a 5-level scale.
Radiation Induced Heart Disease
Patients being seen for the first time at the Cleveland Clinic for Radiation-Induced Heart Disease.
The Cardiac Quality of Life (QOL) survey measures health status in five domains: global, physical, emotional, social, and spiritual health. It also includes questions that assess self-efficacy and resilience. The global section asks about your overall quality of life and satisfaction with health. The physical section asks about symptoms and difficulty performing day-to-day tasks. The emotional section asks about depression, anxiety, and stress. The social section asks about social support and relationships. The spiritual section asks about the spiritual outlook on the burden of heart disease. Responses on a 5-level scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline.
Time Frame: 9 months after baseline visit
The global domain of the Cardiac Quality of Life Survey assesses global health. Three questions related to 1) Perceived overall quality of life, 2) & 3) Satisfaction with overall health status and with heart health. The Perceived overall quality of life responses range from very poor =1 to very good =5. 2) & 3) Satisfaction responses range from very dissatisfied=1 to very satisfied=5. Total global domain score ranges from 3 to 15 points. The higher the score the less impact the cardiac disease has on quality of life.
9 months after baseline visit
Physical domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline
Time Frame: 9 months after baseline visit
The physical domain of the Cardiac Quality of Life Survey assesses physical function. 13 questions. 1) Perception of overall physical health: responses ranging from 1=very poor to 5=very good. 2-6) Difficulty performing day-to-day physical tasks with responses ranging from 1=very easy to 5=very difficult. 7-13) Severity of heart disease symptoms affecting day-to-day physical activities: responses ranging from 1=never to 5=always. Total physical domain score ranges from 13 to 85. The higher the score the less impact the cardiac disease has on physical health.
9 months after baseline visit
Emotional domain of Cardiac Quality of Life Survey assessed 3 months after baseline as compared to baseline.
Time Frame: 9 months after baseline visit
The emotional domain of the Cardiac Quality of Life Survey assesses emotional health. 23 questions. 1) Perception of overall emotional health: responses ranging from 1=very poor to 5=very good. 2) effect of heart disease-related physical limitations on emotional health: responses ranging from 1=always to 5=never. Eight questions asking about anxiety with responses ranging from 1=always to 5=never. Seven questions assessing depression are incorporated with responses ranging from 1=always to 5=never. 19-23) affects from a traumatic event related to their health: responses ranging from 1=always to 5=never. Total emotional domain score ranges from 23 to 115. The higher the score the less impact the cardiac disease has on emotional health.
9 months after baseline visit
Social domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline.
Time Frame: 9 months after baseline visit
The social domain of the Cardiac Quality of life survey assesses social interaction and relationships. 10 questions. 1) Overall social interaction and relationships: responses ranging from 1=very poor to 5=very good. 2) Effect of heart disease-related physical limitations on social interaction: responses ranging from 1=always to 5=never. 3-10) Confidence in social interaction with friends and family: responses ranging from 1=always to 5=never. Total social domain score ranges from 10 to 50. The higher the score, the less impact the cardiac disease has on social health.
9 months after baseline visit
Spiritual domain of quality of life assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.
Time Frame: 9 months after baseline visit
The spiritual domain of the Cardiac Quality of life survey assesses attitudes patients have surrounding their faith and health status. 4 questions. One question asks about if one's faith helps in coping with heart-related problems with responses ranging from 1=strongly disagree to 5=strongly agree. Three questions ask about feelings of anger, injustice, and turmoil related to heart disease with responses ranging from 1=strongly agree to 5=strongly disagree. Total spiritual domain score ranges from 4 to 20. The higher the score, the less impact the cardiac disease has on spiritual health.
9 months after baseline visit
Self-efficacy assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.
Time Frame: 9 months after baseline visit
The self-efficacy domain of the Cardiac Quality of Life survey measures self-efficacy as it relates to symptoms of heart disease. Six questions from the Cardiac Self-Efficacy Questionnaire asks about confidence in controlling symptoms, controlling illness, and maintaining daily functioning with responses ranging from 1=strongly disagree to 5=strongly agree. Total self-efficacy score ranges from 6 to 30. The higher the score, the less impact the cardiac disease has on self-efficacy.
9 months after baseline visit
Resilience assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.
Time Frame: 9 months after baseline visit
The resilience domain of the Cardiac Quality of Life survey measures the ability to recover quickly from difficulties. 9 questions asking about adapting to change, coping with stress, overcoming obstacles, and handling unpleasant feelings with responses ranging from 1=strongly disagree to 5=strongly agree. Total resilience score ranges from 9 to 45. The higher the score, more resilient the participant is in facing problems related to cardiac disease.
9 months after baseline visit
Impact of heritability of cardiac disease assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.
Time Frame: 9 months after baseline visit
Patients with thoracic aortic aneurysm or hypertrophic cardiomyopathy were asked questions about how the heritability of their cardiac disease affected their quality of life. 3 questions asking about how heritable cardiac disease affects the health and happiness of family members with responses ranging from 1=always to 5=never. Total score ranges from 3 to 15. The higher the score, the less impact the heritability of the cardiac disease as on the quality of life of the patient.
9 months after baseline visit
Impact of radiation-induced heart disease (RIHD) assessed at baseline visit in the outpatient clinic.
Time Frame: Baseline visit
RIHD patients are asked about radiation therapy history, awareness of risk of RIHD, and impact on QOL. 7 questions. One question asks about time since last radiation therapy, ranging from 1= less than 5 years ago to 5=more than 30years ago. Another asks about time since RIHD diagnosis, ranging from 1=within the past week to 5=more than five years ago. One question asks about the duration of time between the symptoms of RIHD and diagnosis of RIHD with responses ranging from 1= less than 1 month to 5=more than 1 year. One question asks about the awareness of risk of RIHD before radiation therapy with responses ranging from 1=strongly disagree to 5=strongly agree. These four questions were not totaled. Three questions ask about the overall QOL before and after RIHD diagnosis and after treatment for RIHD. Responses ranged from 1=very poor to 5=very good. Total score for this section ranges from 3 to 15 with a higher score indicating RIHD had less of an impact on the overall QOL.
Baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Milind Desai, M. D., The Cleveland Clinic

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)

August 26, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

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.

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