NCT07103239

Brief Summary

The purpose of this research study is to determine if using remote blood pressure monitoring and video-based consultation is an effective way to help patients in rural communities better manage their heart failure.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
23mo left

Started Jan 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

July 25, 2025

Last Update Submit

January 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Feasibility will be measured by recruitment rates (number screened vs. number enrolled), retention rates (percentage of participants that complete study), and participation metrics. We will aim to enroll at least 40% of the patients we approach for recruitment, and complete follow-up in at least 80% of all enrolled subjects.

    3 months

Study Arms (3)

Video Based Visits

EXPERIMENTAL

Patients assigned to remote consultation will receive a video-based visit with the HF care team using the software platform of the PI's eMedicine division

Behavioral: Video Based Visits

Remote Self-Care Education

EXPERIMENTAL

The intervention will be regular training at designated intervals vs self-guided education

Behavioral: Remote Self-Care Education

Remote Patient Monitoring

EXPERIMENTAL

The devices include a mobile device, blood pressure cuff, and digital scale. The Remote Patient Monitoring team will call the consented participant over the phone to help with setup and use of the devices

Behavioral: Remote Patient Monitoring

Interventions

Participant will use home devices to monitor blood pressure and weight; Participant will then send results to RN educator

Remote Patient Monitoring

Video based visit with Heart Failure team

Video Based Visits

Self Guided Training

Remote Self-Care Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Heart Failure
  • English speaking
  • primary residence in counties of interest

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Stephen Clarkson, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 5, 2025

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations