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RHYTHM-BNCT06527794

Remote Hypertension Management for Black Patients

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 13 words Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Sep 2028 to Sep 19, 2026
    • Study completion moved earlier from Sep 2028 to Mar 2027
    • Secondary endpoints: details revised at 11 of 18 entries
    • Site details revised
  2. Site contact updatedv6
  3. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Eligibility criteria revised
    • Start date changed from estimate of Jan 2025 to Dec 13, 2024
    • Secondary endpoints revised (18)
    • Site details revised
  4. Start date: Nov 2024 to Jan 2025
    • Eligibility criteria expanded, about 91 words
    • Secondary endpoints: 20 to 18
    v4
  5. Start date: Sep 2024 to Nov 2024v3
  6. Collaborators expanded, about 4 wordsv2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12
Timeframe: Month 12

Secondary (18)

Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18
Systolic blood pressure (mmHg) - Baseline
Systolic blood pressure (mmHg) - Month 6
Show 13 moreShow less
Systolic blood pressure (mmHg) - Month 12
Systolic blood pressure (mmHg) - Month 18
Self-Management - Hypertension Self-Care Profile Score - Baseline
Self-Management - Hypertension Self-Care Profile Score - Month 12
Medication adherence - Hill-Bone medication adherence scale survey score - Baseline
Medication adherence - Hill-Bone medication adherence scale survey score - Month 12
Patient assessment of chronic illness care (PACIC) survey score - Baseline
Patient assessment of chronic illness care (PACIC) survey score - Month 12
20-Item Short Form Health Survey (SF-20) - Baseline
20-Item Short Form Health Survey (SF-20) - Month 12
Healthcare Utilization - Number of Acute Care Days - Baseline
Healthcare Utilization - Number of Acute Care Days - Month 12
Healthcare Utilization - Number of Acute Care Days - Month 24

Arms and interventions

RHYTHM (Remote Hypertension Tracking Help Management)Experimental

home blood pressure telemonitoring with remote medication management and social support, lifestyle education and connection to community resources to address social needs

Enhanced usual care (UC)Experimental

standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home

Behavioral: RHYTHM (Remote Hypertension Tracking Help Management), Enhanced usual care (UC)

Sites

1 site in 1 country

  • Wake Forest University Health SciencesWinston-Salem, North Carolina, United States