NCT06692413

Brief Summary

The primary objective is to evaluate the accuracy to predict uncontrolled hypertension with Withings device data.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

Same day

First QC Date

November 12, 2024

Last Update Submit

February 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prediction of uncontrolled hypertension

    Correlation between uncontrolled hypertension, Withings data, and survey answers

    2 years

Secondary Outcomes (2)

  • Correlation between Framingham risk score and EQ-5D-5L answers and Withings data

    2 years

  • Number of Questionnaires answers per participant

    2 years

Study Arms (1)

Withings device users

Active Withings device users having at least 2 years of device data

Other: Questionnaire

Interventions

Users who consent to the study will receive a questionnaire every 3 months

Withings device users

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population meeting the inclusion criteria will all live in the US, regular and active users of one or several WITHINGS devices, who agreed to receive notifications from Withings Clinical Operations department, and who have previously acquired a WITHINGS device. They will receive a notification through their WITHINGS application, offering them the opportunity to participate in the study. In case of a positive answer, the user will be redirected to the study information sheet.

You may qualify if:

  • Male or female who are 21 years of age or older,
  • Participant living in the United States,
  • Participant with data recorded in WITHINGS database,
  • Active WITHINGS device users having at least 2 years of data,
  • Subject able to read, understand, and provide written informed consent,
  • Subject willing and able to participate in the study procedures as described in the consent form,
  • Subject able to communicate effectively with and willing to follow instructions from the study staff.

You may not qualify if:

  • Minors under 21 years old,
  • Subject who refused to participate in the study,
  • Subject who did not reply to the questionnaire,
  • Subject who objected to the processing of his or her data after the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University Medical School, Department of Neurology

New Haven, Connecticut, 06150, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • de Havenon, MD

    Yale University School of Medicine, Dept of Neurology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 18, 2024

Study Start

November 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations