- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04574882
Using Digital Data to Predict CHD
Using Digital Data to Predict Cardiovascular Health and Health Care Utilization
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19101
- University of Pennsylvania Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 30 - 74 years of age
- Willing to sign informed consent
- Primarily English speaking (for language analysis)
- Has an account on any of the following digital data platforms (Facebook, Instagram, Twitter Reddit, Google (gmail), or smartphone or wearable device such as Apple Health, Fitbit, Samsung Health, MapMyFitness or Garmin) and willing to share data
- If has social media account, Instagram or Facebook, willing to share historical and prospective data (60 days) If has Google (gmail) account, willing to download and share google takeout zip file
- If has smartphone or wearable device, willing to share step data
- Willing to share access to medical health records
- Willing to share healthcare insurance information
Exclusion Criteria:
- Patient does not meet age inclusion criteria above
- Does not use and post on digital data sources we are studying or unwilling to donate data
- Patient is in severe distress, e.g. respiratory, physical, or emotional distress
- Patient is intoxicated, unconscious, or unable to appropriately respond to questions
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Case
Patients ages 30-74 with and without CHD (IICD 10: I63, I20-I25 ) within the last 5 years.
|
Interested participants may complete the informed consent online.
After informed consent, the participant will be asked to share the digital data types that they use (Facebook, Instagram, Twitter, Google search, step data) and then participants will complete a cross-sectional survey.
|
|
Control
Patients aged 30-74 who have non-cardiovascular-related history
|
Interested participants may complete the informed consent online.
After informed consent, the participant will be asked to share the digital data types that they use (Facebook, Instagram, Twitter, Google search, step data) and then participants will complete a cross-sectional survey.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Latent Dirichlet Allocation (LDA) Topics - Topics / Themes Discussed Between Patients With and Without Heart Disease
Time Frame: Through study completion, an average of 3 years
|
The primary outcome is topics and features (derived using the LDA method for clustering language data). For each participant, we included all available Facebook wall posts from the start of their account history through data collection, regardless of whether they occurred before or after a CHD diagnosis. We examined associations between linguistic features (unigrams, LIWC categories, LDA topics) and cardiovascular case status (CHD presence vs absence) using Pearson correlation and logistic regression. Latent LDA, a systematic method to identify text-based themes, was applied to generate 200 clusters of co-occurring words ("topics"). For each feature type (unigram, LIWC category, LDA topic), we fit separate logistic regression models and calculated Pearson correlation coefficients to assess predictive value for case status. Each language-derived feature was encoded as a normalized frequency count per user to enable consistent comparison across participants. |
Through study completion, an average of 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CHD Event
Time Frame: Through study completion, an average of 3 years
|
Reliability in predicting CHD related event in patient as measured by Framingham Risk Score. The Framingham Risk Score (FRS) is a validated means of predicting cardiovascular disease (CVD) risk. Input variables include age, cigarette smoking, total cholesterol, HDL cholesterol, systolic blood pressure measurement and treatment for hypertension. Point values are calculated based on each of these risks. A 10-year risk score can be derived as a percentage. Risk scores range from 0-20%. Low Risk: Less than 10% risk that you will develop a heart attack or die from coronary disease in the next 10 years. Intermediate risk: A 10 to 20% risk that you will develop a heart attack or die from coronary disease in the next 10 years. High Risk: A greater than 20% risk that you will develop a heart attack or die from coronary disease in the next 10 years. |
Through study completion, an average of 3 years
|
|
Health Care Utilization
Time Frame: Through study completion, an average of 3 years
|
Prediction of cost for health care utilization between heart disease and non- heart disease subjects measured by insurance claims data
|
Through study completion, an average of 3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 833699
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cardiovascular Diseases
-
Weill Medical College of Cornell UniversityAmerican Heart AssociationRecruitingCardiovascular | Cardiovascular Health | Cardiovascular (CV) Risk | Cardiovascular Disease (CVD) Risk FactorsUnited States
-
Hull University Teaching Hospitals NHS TrustNot yet recruitingCardiovascular Surgery | Cardiovascular Diseases (CVD)United Kingdom
-
Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
-
Medical College of WisconsinNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
IRCCS Policlinico S. DonatoIRCCS San Raffaele; Fondazione Policlinico Universitario Agostino Gemelli IRCCS and other collaboratorsRecruitingCardiovascular Risk | Genetic Cardiovascular RiskItaly
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
Children's Hospital Medical Center, CincinnatiRecruitingCardiovascular Diseases (CVD)United States
Clinical Trials on Survey
-
Johns Hopkins Bloomberg School of Public HealthPontificia Universidad JaverianaCompletedNoncommunicable Diseases | Surveys and QuestionnairesColombia
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSarcoma | Breast Carcinoma | Head and Neck CarcinomaUnited States
-
Weill Medical College of Cornell UniversityBoston Children's Hospital; Brigham and Women's Hospital; The Commonwealth FundCompletedPediatric ALLUnited States
-
Memorial Sloan Kettering Cancer CenterEnrolling by invitationSurvivors of Unilateral RetinoblastomaUnited States
-
Jaseng Medical FoundationCompletedFractures, Bone | Medicine, Korean TraditionalKorea, Republic of
-
M.D. Anderson Cancer CenterCompleted
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Université de Cergy PontoiseCompleted
-
Sarasota Memorial Health Care SystemEnrolling by invitation
-
Ohio State UniversityWithdrawnMedicare Part DUnited States