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Behavioral Interventions Combining AI/ML and Personalized Medicine to Reduce Cardiovascular Risk - Randomized Controlled Trial

21. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

3000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: RCT Arm A: Digital health tool
Participants in this arm will receive the Digital Health Tool intervention.
Andet: Digital heath tool
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.
Eksperimentel: 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.
Andet: Digital heath tool
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.
Andet: Low-intensity recommendation
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.
Eksperimentel: 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.
Andet: Digital heath tool
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.
Andet: High-intensity recommendation
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Systolic blood pressure measurement
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Bureau of Economic Research, Inc.

Samarbejdspartnere

University of California, San Diego
National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Itzik Fadlon, National Bureau of Economic Research, Inc.
  • Ledende efterforsker: Ming Tai-Seale, University of California, San Diego

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. april 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. april 2027

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 8577_RCT
  • 5P30AG034532 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner