Congenital Heart DiseaseNCT03912025
The Relationship Between Having a Positive Mindset and Exercise Capacity in Patients With Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
Trial summary
A cross sectional study utilizing congenital heart disease patients presenting for clinically indicated cardiopulmonary exercise test. Baseline questionnaires (see below) will be administered prior to the exercise test. Exercise test data and clinical data will be recorded. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Relationship between positive mindset and exercise capacity
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 25 Apr 2021
- 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 8 to 17 years
- All sexes
- Child
Study population: Congenital Heart disease Patients
Who may be able to join
- Patients age 8-17 with congenital heart disease
- Classified as mild or moderate hemodynamic severity
- Presenting to outpatient department for clinically indicated cardiopulmonary exercise test
Who cannot join
- Patients on beta blockers or negative inotropes
- Patients with pacemakers/ICDs
- Patients with active arrhythmias
- Patients with significant musculoskeletal or pulmonary disease
- Patients unable to complete a maximal exercise test or for whom an exercise test is contraindicated
- Patients who are not fluent in English
- Patients unable to complete the questionnaire
- Patients who have severely hemodynamic debilitation or at risk (severe systolic dysfunction, severe ventricular hypertrophy, severe pressure load, severe volume load, severe pulmonary hypertension, malignant arrhythmia, significant central cyanosis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
A cross sectional study utilizing congenital heart disease patients presenting for clinically indicated cardiopulmonary exercise test. Baseline questionnaires (see below) will be administered prior to the exercise test. Exercise test data and clinical data will be recorded. Questionnaire data will be compared to clinical data in and between disease severity groups. Disease severity will be determined based on hemodynamic (not anatomic) classification according to an algorithm adapted from the European Society of Cardiology.
Read the detailed description
Patients with congenital heart disease (CHD) have variable degrees of exercise capacity and levels of physical activity that is not necessarily related to disease severity (1,2) and is not fixed as supervised exercise training can achieve improved fitness across a spectrum of hemodynamic deficits (3-5). Effectiveness of training relates to frequency, intensity, time, and type of exercise as well as motivation to participate. Research in the psychology literature in athletes and in non-athletes alike has demonstrated that optimism and positive mentality result in improved exercise capacity, enhanced training results, and resilience to stress (6-11). Further, the general concept of resilience in children may be the sum result of the balance of positive and negative inputs (12), and these factors are also modifiable. The degree with which having a positive mindset impacts functional capacity irrespective of congenital heart disease severity is not known; if there is a correlation, then the idea that mindset could potentially be a target for an intervention to improve health in children with CHD is intriguing.
This study seeks to assess the correlation of positive thinking to physiological outcomes by comparing the degree of positive mindset of patients with congenital heart disease (as measured by questionnaire data to assess the balance of optimistic thinking to anxiety) with their functional capacity (as measured by peak oxygen consumption (peakVO2) on exercise testing). The ability to measure "mindset" in the clinic setting is now feasible after the recent release of a set of validated questionnaires for children (and parent-proxies) known as PROMIS (Patient-Reported Outcomes Measurement Information System), developed under the auspices of the National Institutes of Health (www.healthmeasures.net/explore-measurement-systems/promis). These questionnaires are short (4-8 questions), free, and integrate into the Research Electronic Data Capture (REDCap) database, making delivery Health Insurance Portability and Accountability Act (HIPAA) compliant and scoring automatic. In addition, the PROMIS measures contain both retrospective positive quality of life questions (life satisfaction, positive well-being) as well as a future facing tool measuring degree of optimism and purpose, making it ideally suited for the present research proposal. While PROMIS tools have been utilized in childhood chronic illnesses such as arthritis and kidney disease, they have not yet been reported in children with congenital heart disease. Thus, a secondary goal of this proposal is to assess the distribution of meaning and purpose scores and anxiety scores of children with CHD compared to the population norms.
- Conditions
- Congenital Heart Disease
- Being tested
- Relationship between positive mindset and exercise capacity
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship between positive mindset and exercise capacityOther
No intervention. Cross-sectional study looking at the relationships between questionnaire scores and outcomes
| Study group | Role | What they receive |
|---|---|---|
| Mild hemodynamic CHD | "Mild" severity category will be defined in terms of hemodynamic parameters rather than anatomic diagnoses, as outlined in the European Society of Cardiology Section on Sports Cardiology consensus guidelines (Budts W, Borjesson M, Chessa M, van Buuren F, Trindade PT, Corrado D, Heidbuchel H, Web G, Holm J, Papadakis M. 2013).
They define functional parameters such as systolic function, oxygen saturation, rhythm disorders, elevated pressure or volume load, etc. to divide patients into 3 hemodynamic groups. Based on their model, we define "mild CHD" as ones falling into the group that can train at "High Intensity" exercise levels. Receives: Other: Relationship between positive mindset and exercise capacity | |
| Moderate hemodynamic CHD | "Moderate" severity category will be defined in terms of hemodynamic parameters rather than anatomic diagnoses. Based on their model, we define "moderate CHD" as those that can train at "Moderate Intensity." Receives: Other: Relationship between positive mindset and exercise capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Meaning and Purpose Score
A series of 8 questions that ask about future hopes, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Meaning and Purpose, a T-score of 60 is one SD better than average. By comparison, a Meaning and Purpose T-score of 40 is one SD worse than average.
Measured: up to 60 minutes
Patient Reported Outcomes Measurement Information System Pediatric Anxiety Score
A series of 8 questions to assess the degree of anxiety felt in the past week, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. For negatively-worded concepts like anxiety, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.
Measured: up to 60 minutes
Ratio of Meaning and Purpose Score to Anxiety Score
Since positive mindset is represented by a high score on the Meaning and Purpose scale, and a low score on the Anxiety scale, patients with high ratios (greater than 1) will have the most positive mindsets, while those with low ratios (less than 1) will have the least positive mindsets.
Measured: up to 60 minutes
Secondary outcomes (4)
Patient Reported Outcomes Measurement Information System Physical Activity Questionnaire
Self-reported physical activity questionnaire, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. For positively-worded concepts like Physical Activity, a T-score of 60 is one SD better than average. By comparison, a Physical Activity T-score of 40 is one SD worse than average.
Measured: up to 60 minutes
Patient Reported Outcomes Measurement Information System Pediatric Life Satisfaction Score
A series of 8 questions used as markers of current and recent (but not future) positive functioning, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. For positively-worded concepts like Life Satisfaction, a T-score of 60 is one SD better than average. By comparison, a Life Satisfaction T-score of 40 is one SD worse than average.
Measured: up to 60 minutes
Patient Reported Outcomes Measurement Information System Pediatric Positive Affect/Well Being Score
A series of 8 questions assessing friendships, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. For positively-worded concepts like Positive Affect, a T-score of 60 is one SD better than average. By comparison, a Positive Affect T-score of 40 is one SD worse than average.
Measured: up to 60 minutes
Pediatric Cardiac Quality of Life Inventory Questionnaire (PCQLI)
A standard quality of life tool for congenital heart disease. Three scores are generated: Disease Impact subscale score, Psychosocial Impact subscale score, and Total score. Disease Impact subscale score (up to 50 points) + Psychosocial Impact subscale score (up to 50 points) = Total score, for a maximum of 100 points. Higher scores represent better perceived health related quality of life.
Measured: up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start30 Jan 2020
- Primary completion12 Apr 2021
- Study completion25 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Gauthier, Boston Children's Hospital
- Investigators
- Naomi Gauthier, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912025
- Sponsor's protocol ID
- P00030619
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2019
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Having a Positive Mindset and Exercise Capacity in Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03912025
- Acronym / sponsor ID
- P00030619
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 11 Apr 2019 (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.
A cross sectional study utilizing congenital heart disease patients presenting for clinically indicated cardiopulmonary exercise test. Baseline questionnaires (see below) will be administered prior to the exercise test. Exercise test data and clinical data will be recorded. Questionnaire data will be compared to clinical data in and between disease severity groups. Disease severity will be determined based on hemodynamic (not anatomic) classification according to an algorithm adapted from the European Society of Cardiology.
Detailed description
Patients with congenital heart disease (CHD) have variable degrees of exercise capacity and levels of physical activity that is not necessarily related to disease severity (1,2) and is not fixed as supervised exercise training can achieve improved fitness across a spectrum of hemodynamic deficits (3-5). Effectiveness of training relates to frequency, intensity, time, and type of exercise as well as motivation to participate. Research in the psychology literature in athletes and in non-athletes alike has demonstrated that optimism and positive mentality result in improved exercise capacity, enhanced training results, and resilience to stress (6-11). Further, the general concept of resilience in children may be the sum result of the balance of positive and negative inputs (12), and these factors are also modifiable. The degree with which having a positive mindset impacts functional capacity irrespective of congenital heart disease severity is not known; if there is a correlation, then the idea that mindset could potentially be a target for an intervention to improve health in children with CHD is intriguing.
This study seeks to assess the correlation of positive thinking to physiological outcomes by comparing the degree of positive mindset of patients with congenital heart disease (as measured by questionnaire data to assess the balance of optimistic thinking to anxiety) with their functional capacity (as measured by peak oxygen consumption (peakVO2) on exercise testing). The ability to measure "mindset" in the clinic setting is now feasible after the recent release of a set of validated questionnaires for children (and parent-proxies) known as PROMIS (Patient-Reported Outcomes Measurement Information System), developed under the auspices of the National Institutes of Health (www.healthmeasures.net/explore-measurement-systems/promis). These questionnaires are short (4-8 questions), free, and integrate into the Research Electronic Data Capture (REDCap) database, making delivery Health Insurance Portability and Accountability Act (HIPAA) compliant and scoring automatic. In addition, the PROMIS measures contain both retrospective positive quality of life questions (life satisfaction, positive well-being) as well as a future facing tool measuring degree of optimism and purpose, making it ideally suited for the present research proposal. While PROMIS tools have been utilized in childhood chronic illnesses such as arthritis and kidney disease, they have not yet been reported in children with congenital heart disease. Thus, a secondary goal of this proposal is to assess the distribution of meaning and purpose scores and anxiety scores of children with CHD compared to the population norms.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild hemodynamic CHD | – | Other: Relationship between positive mindset and exercise capacity"Mild" severity category will be defined in terms of hemodynamic parameters rather than anatomic diagnoses, as outlined in the European Society of Cardiology Section on Sports Cardiology consensus guidelines (Budts W, Borjesson M, Chessa M, van Buuren F, Trindade PT, Corrado D, Heidbuchel H, Web G, Holm J, Papadakis M. 2013). They define functional parameters such as systolic function, oxygen saturation, rhythm disorders, elevated pressure or volume load, etc. to divide patients into 3 hemodynamic groups. Based on their model, we define "mild CHD" as ones falling into the group that can train at "High Intensity" exercise levels. |
| Moderate hemodynamic CHD | – | Other: Relationship between positive mindset and exercise capacity"Moderate" severity category will be defined in terms of hemodynamic parameters rather than anatomic diagnoses. Based on their model, we define "moderate CHD" as those that can train at "Moderate Intensity." |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Congenital Heart disease Patients
Key inclusion criteria (3 listed)
- Patients age 8-17 with congenital heart disease
- Classified as mild or moderate hemodynamic severity
- Presenting to outpatient department for clinically indicated cardiopulmonary exercise test
Key exclusion criteria (8 listed)
- Patients on beta blockers or negative inotropes
- Patients with pacemakers/ICDs
- Patients with active arrhythmias
- Patients with significant musculoskeletal or pulmonary disease
- Patients unable to complete a maximal exercise test or for whom an exercise test is contraindicated
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 |
|---|---|---|
| Relationship between positive mindset and exercise capacityNo intervention. Cross-sectional study looking at the relationships between questionnaire scores and outcomes | Other | Mild hemodynamic CHD, Moderate hemodynamic CHD |
Primary outcome
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Meaning and Purpose Score
Time frame: up to 60 minutes
A series of 8 questions that ask about future hopes, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Meaning and Purpose, a T-score of 60 is one SD better than average. By comparison, a Meaning and Purpose T-score of 40 is one SD worse than average.
Patient Reported Outcomes Measurement Information System Pediatric Anxiety Score
Time frame: up to 60 minutes
A series of 8 questions to assess the degree of anxiety felt in the past week, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. For negatively-worded concepts like anxiety, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.
Ratio of Meaning and Purpose Score to Anxiety Score
Time frame: up to 60 minutes
Since positive mindset is represented by a high score on the Meaning and Purpose scale, and a low score on the Anxiety scale, patients with high ratios (greater than 1) will have the most positive mindsets, while those with low ratios (less than 1) will have the least positive mindsets.
4 secondary outcomes
Patient Reported Outcomes Measurement Information System Physical Activity Questionnaire
Time frame: up to 60 minutes
Patient Reported Outcomes Measurement Information System Pediatric Life Satisfaction Score
Time frame: up to 60 minutes
Patient Reported Outcomes Measurement Information System Pediatric Positive Affect/Well Being Score
Time frame: up to 60 minutes
Pediatric Cardiac Quality of Life Inventory Questionnaire (PCQLI)
Time frame: up to 60 minutes
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 4 Aug 2021.
- 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.
Naomi Gauthier, MD principal investigator
Boston Children's Hospital
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 Congenital Heart Disease, run by Boston Children's Hospital 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 3 inclusion and 8 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 4 Aug 2021. 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?
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Meaning and Purpose Score (time frame: up to 60 minutes). The study lists 3 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 4 Aug 2021.