Withings Devices Follow-up Study - Hypertension

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

Study Overview

• Status: Withdrawn
• Conditions: Hypertension
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06150
      • Yale University Medical School, Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Withings device users; Active Withings device users having at least 2 years of device data	Other: Questionnaire; Users who consent to the study will receive a questionnaire every 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of uncontrolled hypertension	Correlation between uncontrolled hypertension, Withings data, and survey answers	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Framingham risk score and EQ-5D-5L answers and Withings data	Correlation between Framingham risk score and EQ-5D-5L answers and Withings data	2 years
Number of Questionnaires answers per participant	Number of Questionnaires answers per participant	2 years

Collaborators and Investigators

• Sponsor: Withings
• Investigators: Principal Investigator: de Havenon, MD, Yale University School of Medicine, Dept of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: WIQUEST-HTA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No