Telemonitoring Hypertension and Breast Cancer
NCT05574686 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-05-10
Summary
The goal of this clinical trial-prospective study will provide important information on equitable implementation strategies to improve hypertension management in women with breast cancer by evaluating the feasibility and safety of remote hypertension management using home blood pressure telemonitoring that will provide individualized hypertension management, health and wellness education for hypertension prevention of women with breast cancer stages I-IV. Also this study may provide evidence to inform a potential paradigm shift in joint social and clinical management of hypertension that future studies may use to address complex social and clinical comorbidities that affect women with hypertension in Mississippi. The main questions this study aims to answer are:
1. To examine the feasibility of using home BP telemonitoring to provide individualized hypertension management in a population of women with breast cancer and food insecurity.
2. To examine the effectiveness of telemonitoring in achieving 2017 ACC/AHA guidelines for hypertension control in women with breast cancer and food insecurity using the RE-AIM framework.
3. To pilot the integration of a community service partnership to decrease food insecurity in the 40 women who participate in the home BP telemonitoring program.
Using the mailed telemonitoring kit (iPad tablet and Blood Pressure Cuff) the participants of this study will be asked to access a daily health session using iPad and obtain a blood pressure measurement using blood pressure cuff that transmits readings wirelessly via Bluetooth to the tablet which is uploaded directly to the participants UMMC electronic health records. Participants are asked to obtain two consecutive blood pressure measurements during each session and register at least 6 sessions per week. The study duration will be 6 months. Every 2 weeks blood pressure measurements will be assessed. If less than 75% of measurements are at goal systolic blood pressure 75% of measurements are at goal systolic blood pressure\<130mmHg and diastolic blood pressure \<80mmHg, the patients nurse coordinator will contact them via telephone and assess for medication adherence and report to the patient's primary care provider and oncologist.
Conditions
Interventions
- BEHAVIORAL
-
Telehealth Blood Pressure Monitoring and Food Insecurity
Telehealth Blood Pressure Monitoring and Food Insecurity
Sponsors & Collaborators
-
Cheryl Clark, MD, ScD
collaborator UNKNOWN -
Saurabh Chandra, MD
collaborator UNKNOWN -
Richard Summers, MD
collaborator UNKNOWN -
University of Mississippi Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-01
- Primary Completion
- 2023-05-31
- Completion
- 2023-05-31
Countries
- United States
Study Locations
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