Monitoring Blood Pressure at Home and Pharmacy Telehealth (REMAP-BP)
11 juni 2026 uppdaterad av: Lama Ghazi, University of Alabama at Birmingham
REmote Blood Pressure Monitoring and Pharmacist-Led Telehealth Program in an Emergency Department Transitional Care Clinic
The overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage participants' blood pressure is useful.
The study will enroll 400 participants who are seen at the University of Alabama at Birmingham Emergency Department - Transitional Care Clinic and Tampa General Hospital -Transitional Care Clinic.
Half of the participants (200 patients) will be asked to measure blood pressure at home, and half of the participants (200 patients) will continue to receive usual care.
Participants who measure blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed.
This program will last 6 months.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Detaljerad beskrivning
For all participants:
- Participants will receive information on the importance of measuring blood pressure and ways to improve blood pressure.
- Participants will complete questionnaires describing current socioeconomic position, medical history and healthcare needs.
- Participants will come in for three research clinic visits to get blood pressure measured 3 months after enrollment in this study, and 6 months after enrollment in this study.
For participants asked to measure blood pressure at home:
- Measure blood pressure twice a day at home, following the instructions provided. The study will provide participants with the device and send text message reminders each week day. Participants will return the device at study visit 3 months from now.
- Following the instructions provided, participants will talk to a pharmacist over the phone weekly to discuss blood pressure and medications. All medication changes will be discussed with a collaborating physician.
- Participants will complete questionnaires and interviews on satisfaction with the program.
Studietyp
Interventionell
Inskrivning (Beräknad)
420
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Bernadette Johnson
- Telefonnummer: 205-934-7329
- E-post: bajohnson@uabmc.edu
Studera Kontakt Backup
- Namn: Tammi Thomas
- Telefonnummer: 205-934-7839
- E-post: tammithomas@uabmc.edu
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35233
- University of Alabama at Birmingham
-
Kontakt:
- Bernadette Johnson
- Telefonnummer: 205-934-7329
- E-post: bajohnson@uabmc.edu
-
Kontakt:
- Tammi Thomas
- Telefonnummer: 205-934-7839
- E-post: tammithomas@uabmc.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Age ≥18 years
- Ability to speak English
- Seen at UAB's or TGH's Emergency Department-Transitional Care Clinic
- Blood pressure at Emergency Department-Transitional Care Clinic: Systolic BP ≥ 130 mmHg or Diastolic BP ≥ 80 mmHg
- Have a cellphone with video capability
Exclusion Criteria:
- Systolic BP ≥ 160 mmHg or Diastolic BP ≥ 100 mmHg (i.e. severe range hypertension (HTN) by the 2025 American College of Cardiology/American Heart Association BP guidelines) as they typically are referred to immediate treatment intensification. Since the prevalence of severe HTN is low (i.e.<5%) in the US population, exclusion of these individuals will have only a small effect on the study.)
- Lack of willingness or inability to provide written informed consent
- Individuals who work overnight or second shift
- History of known major arrhythmias
- Currently pregnant or breastfeeding
- Arm circumference >50 cm. *The upper limit for the largest BP cuff for oscillometric BP devices is typically 50-52 cm; data from the National Health and Nutrition Examination Survey, 2011-2016 indicated that <1% of US adults have an arm circumference >50 cm, so this will have minimal effect on our study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Fjärrkontroll av blodtryck + Telehälsa
Deltagarna kommer att genomgå fjärrövervakning av blodtryck och läkemedelsledd telehälsointervention för blodtryckshantering
|
Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management
|
|
Inget ingripande: Usual Care
Participants receive usual care from providers to manage blood pressure
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total Number of Enrolled Participants with Blood Pressure Control
Tidsram: 12 weeks (3 months) from randomization
|
The number of enrolled participants with blood pressure control
|
12 weeks (3 months) from randomization
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants in the Intervention with Patient-Reported Outcomes
Tidsram: 24 weeks (6 months) from randomization
|
The number of participants with completed qualitative interviews and surveys regarding intervention adherence and satisfaction. The survey will assess intervention adherence and satisfaction using the following scales: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and the Feasibility of Intervention Measure (FIM). The AIM is a 4-item scale where the min. value per item is 1 and the max. value per item is 5. A higher total score indicates better acceptability while the lower total score indicates worse acceptability. The IAM is a 4-item scale where the min. value per item is 1 and the max. value per item is 5. A higher total score indicates better appropriateness while the lower total score indicates worse appropriateness. The FIM is a 4-item scale where the min. value per item is 1 and the max. value per item is 5. A higher total score indicates better feasibility while the lower total score indicates worse feasibility. |
24 weeks (6 months) from randomization
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Lama Ghazi, MD, PhD, University of Alabama at Birmingham
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 april 2027
Primärt slutförande (Beräknad)
1 januari 2031
Avslutad studie (Beräknad)
1 januari 2031
Studieregistreringsdatum
Först inskickad
28 maj 2026
Först inskickad som uppfyllde QC-kriterierna
28 maj 2026
Första postat (Faktisk)
3 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-300016615
- National Heart, Lung, & Blood (Annan identifierare: National Heart, Lung, and Blood Institute (NHLBI))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
While the investigators do not anticipate generating research tools, the investigators are committed to adhering to the National Institutes of Health (NIH) Research Tools Policy to ensure that any resources developed under this award are readily available to qualified researchers.
If an NIH-defined research tool is developed, the investigators will collaborate with University of Alabama at Birmingham Commercialization and Licensing Office and all participating institutions to define ownership, protect intellectual property, and establish a dissemination strategy that ensures appropriate access and compliance with NIH guidelines.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .