Feasibility and Acceptability of Three Component Intervention for the Heart Failure Care for Rural Dwelling Participants

NCT ID: NCT07103239

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-01-31

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Video Based Visits

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

Group Type EXPERIMENTAL

Video Based Visits

Intervention Type BEHAVIORAL

Video based visit with Heart Failure team

Remote Self-Care Education

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

Group Type EXPERIMENTAL

Remote Self-Care Education

Intervention Type BEHAVIORAL

Self Guided Training

Remote Patient Monitoring

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

Group Type EXPERIMENTAL

Remote Patient Monitoring

Intervention Type BEHAVIORAL

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

Interventions

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Video Based Visits

Video based visit with Heart Failure team

Intervention Type BEHAVIORAL

Remote Self-Care Education

Self Guided Training

Intervention Type BEHAVIORAL

Remote Patient Monitoring

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Stephen Clarkson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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Stephen Clarkson, MD

Role: CONTACT

205-975-7123

Facility Contacts

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Stephen Clarkson, MD

Role: primary

1-855-860-3789

Other Identifiers

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1K23HL179489-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300015100

Identifier Type: -

Identifier Source: org_study_id

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