Mobile Health Management of Hypertension

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05856955
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mHealth Coaching Intervention — BEHAVIORAL
    The intervention uses a mHealth virtual tool that facilitates human-device interaction and is delivered by smartphone application. The program has coaching and education components that lead to chronic disease behavior change. It has been previously validated to improve self-management, medication adherence, and quality of life in individuals with CVD. The participant engages by selecting responses on the touch screen. In this manner, participants converse with the coach, develop a therapeutic alliance, and record responses. The investigators will institute behavior change methodology to enhance intervention efficacy.
  • Enhanced Usual Care — BEHAVIORAL
    Smart phone without health coach. A basic health application is installed on the smart phone provided to the participant.

Study Details

The investigators will pilot test a hypertension self-management intervention for feasibility and acceptability. The investigators will enroll adults (age ≥18) with uncontrolled hypertension, identified from the electronic health record. In this feasibility trial, the research aim is to explore trial design, participant acceptability of the intervention and outcome measures, and to generate data to inform the design of a future randomized controlled trial.

Key Dates

Start date
Sep 30, 2027
Status verified
May 2025
Primary completion
Aug 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Enhanced Usual Care
    The active comparison group will receive a smartphone with the WebMD® health information application preloaded and a BP monitor. After recruitment, participants will receive a confirmatory interview, informed consent, and baseline device training via telephone, delivered by an experienced research assistant. Participants will be encouraged to complete 1 morning BP reading daily, irrespective of study arm. BP readings are automatically uploaded via Bluetooth to a centralized, secure platform to be accessible to the study PI.
  • Experimental: Behavioral mHealth Coaching Intervention
    Those randomized to the intervention group will receive a smartphone with the intervention program preloaded in addition to a BP monitor. After recruitment, participants will receive a confirmatory interview, informed consent, and baseline device training via telephone, delivered by an experienced research assistant. Participants will be encouraged to complete 1 morning BP reading daily, irrespective of study arm, however, only the intervention group will receive reminders from the mHealth coaching intervention to check BP daily. BP readings are automatically uploaded via Bluetooth to a centralized, secure platform to be accessible to the study PI.

Primary Outcome Measure

Participant acceptance and adherence to program [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Amber Johnson
[email protected]
773-702-7769

Find similar trials in Chicago, IL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Chicago· Chicago, IL

Related Studies