Behavioral Interventions Combining AI/ML and Personalized Medicine to Reduce Cardiovascular Risk - Randomized Controlled Trial
21. juli 2026 oppdatert av: National Bureau of Economic Research, Inc.
This study evaluates a new digital health program that uses artificial intelligence (AI) to help patients lower their blood pressure through personalized lifestyle recommendations.
The program collects information about patients' daily habits and blood pressure readings, then uses AI to suggest lifestyle changes that may work best for each person.
The study will measure how well this program works across different groups of patients and aims to improve the program design to make it more effective and easier to use.
The program will be offered to diverse patients at UC San Diego Health, including people of different ages, genders, races/ethnicities, and economic backgrounds, as part of their regular healthcare services.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
3000
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Amanda Walker
- Telefonnummer: 617-588-1445
- E-post: Alw038@health.ucsd.edu
Studer Kontakt Backup
- Navn: Ross Graham
- E-post: rograham@health.ucsd.edu
Studiesteder
-
-
California
-
La Jolla, California, Forente stater, 92093
- Rekruttering
- University of California, San Diego
-
Ta kontakt med:
- Amanda Walker
- Telefonnummer: 617-588-1445
- E-post: Alw038@health.ucsd.edu
-
Ta kontakt med:
- Ross Graham
- E-post: rograham@health.ucsd.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Stage I-II hypertension (average clinical readings of blood pressure over 140/90)
- Adequate decisional capacity to make a choice about participating in this research study
- Fully ambulatory (not requiring assistive device such as a cane, wheelchair, walker, etc.)
Exclusion Criteria:
- Pregnancy
- Under age 18 years
- Institutionalized individuals who are likely to be vulnerable
- Dependent on supplemental oxygen
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: RCT Arm A: Digital health tool
Participants in this arm will receive the Digital Health Tool intervention.
|
Digital health tool of patient-tailored lifestyle recommendations for blood pressure maintenance.
Current "simplified" remote patient monitoring program referred to as "P1000."
Requires daily blood pressure readings only.
|
|
Eksperimentell: RCT Arm B.1: Digital health tool + low-intensity recommendations
Participants in this arm will receive the Digital Health Tool and Low-Intensity Recommendation interventions.
|
Digital health tool of patient-tailored lifestyle recommendations for blood pressure maintenance.
Current "simplified" remote patient monitoring program referred to as "P1000."
Requires daily blood pressure readings only.
AI-enhanced lifestyle and health recommendations provided weekly.
This requires blood pressure readings, as well as passive readings, (e.g.
sleep, movement), and a daily questionnaire.
|
|
Eksperimentell: RCT Arm B.2: Digital health tool + high-intensity recommendations
Participants in this arm will receive the Digital Health Tool and High-Intensity Recommendation interventions.
|
Digital health tool of patient-tailored lifestyle recommendations for blood pressure maintenance.
Current "simplified" remote patient monitoring program referred to as "P1000."
Requires daily blood pressure readings only.
AI-enhanced lifestyle and health recommendations provided weekly, plus daily reminders.
This requires blood pressure readings, as well as passive readings, (e.g.
sleep, movement), and a daily questionnaire.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Systolic blood pressure measurement
Tidsramme: 6 months
|
6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Itzik Fadlon, National Bureau of Economic Research, Inc.
- Hovedetterforsker: Ming Tai-Seale, University of California, San Diego
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. april 2026
Primær fullføring (Antatt)
30. april 2027
Studiet fullført (Antatt)
30. april 2027
Datoer for studieregistrering
Først innsendt
21. juli 2026
Først innsendt som oppfylte QC-kriteriene
21. juli 2026
Først lagt ut (Faktiske)
24. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 8577_RCT
- 5P30AG034532 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All study data, except for identifiers, will be shared.
Before data is shared publicly, all identifiers will be removed in keeping with HIPAA standards (i.e., §164.514(b)1 or (b)2) and the standards of the IRB of Record.
Identifiable data will not be shared publicly and will be stored only on secure servers and accessed only by personnel with appropriate training and a legitimate need to know.
IPD-delingstidsramme
We plan to publicly archive our statistical analysis plan (SAP) and study protocol at ClinicialTrials.gov before performing any data analysis. This will serve both as an ex ante record of the hypotheses to be tested and provide a resource to other researchers interested in implementing similar study designs.
We plan to share the individual participant data (IPD), analytic code, and supporting materials in multiple ways. The resources will be posted to ClinicalTrials.gov by the paper's online publication date or within 12 months of the primary completion date (whichever comes first), in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149). We will also catalog public use data and analytic code on the NBER Data Archive (www.nber.org/data/) to encourage its use by the wider community. We expect to receive institutional approval at the appropriate times for all resource sharing.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .