Blood Pressure, Hypertension
Conditions
Keywords
Cardiovascular Diseases, Delivery of Health Care, Patient Care Management, Health Services Administration, Telemedicine, Vascular Diseases
Brief summary
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.
Detailed description
For all participants: 1. Participants will receive information on the importance of measuring blood pressure and ways to improve blood pressure. 2. Participants will complete questionnaires describing current socioeconomic position, medical history and healthcare needs. 3. 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: 1. 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. 2. 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. 3. Participants will complete questionnaires and interviews on satisfaction with the program.
Interventions
Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management
Sponsors
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Enrolled Participants with Blood Pressure Control | 12 weeks (3 months) from randomization | The number of enrolled participants with blood pressure control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in the Intervention with Patient-Reported Outcomes | 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. |
Countries
United States
Contacts
CONTACTTammi Thomas
CONTACTBernadette Johnson
PRINCIPAL_INVESTIGATORLama Ghazi, MD, PhD
University of Alabama at Birmingham
Outcome results
None listed