Heart FailureNCT07103239
Feasibility and Acceptability of Three Component Intervention for the Heart Failure Care for Rural Dwelling Participants
A study testing Video Based Visits, Remote Self-Care Education and Remote Patient Monitoring in people with Heart Failure, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Video Based Visits, Remote Self-Care Education and Remote Patient Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Heart Failure
- English speaking
- primary residence in counties of interest
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Stephen Clarkson, MD, 1-855-860-3789, sclarkso@uab.edu
Stephen Clarkson, MD
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Video Based Visits, Remote Self-Care Education, Remote Patient Monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Based VisitsBehavioural
Video based visit with Heart Failure team
Remote Self-Care EducationBehavioural
Self Guided Training
Remote Patient MonitoringBehavioural
Participant will use home devices to monitor blood pressure and weight; Participant will then send results to RN educator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Video Based Visits |
| Remote Self-Care Education | Experimental | The intervention will be regular training at designated intervals vs self-guided education Receives: 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 Receives: Behavioral: Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Stephen Clarkson, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103239
- Sponsor's protocol ID
- IRB-300015100
- Other IDs
- 1K23HL179489-01
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Three Component Intervention for the Heart Failure Care for Rural Dwelling Participants
- ClinicalTrials.gov ID
- NCT07103239
- Acronym / sponsor ID
- IRB-300015100
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video Based Visits | Experimental | Behavioral: Video Based VisitsPatients 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 |
| Remote Self-Care Education | Experimental | Behavioral: Remote Self-Care EducationThe intervention will be regular training at designated intervals vs self-guided education |
| Remote Patient Monitoring | Experimental | Behavioral: Remote Patient MonitoringThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of Heart Failure
- English speaking
- primary residence in counties of interest
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Based VisitsVideo based visit with Heart Failure team | Behavioural | Video Based Visits |
| Remote Self-Care EducationSelf Guided Training | Behavioural | Remote Self-Care Education |
| Remote Patient MonitoringParticipant will use home devices to monitor blood pressure and weight; Participant will then send results to RN educator | Behavioural | Remote Patient Monitoring |
Primary outcome
Feasibility
Time frame: 3 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Based Visits, Remote Self-Care Education and Remote Patient Monitoring in people with Heart Failure, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Clarkson, MD (205-975-7123, sclarkso@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.