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Remote Monitoring and Social Support for Hypertension Management (SupportBP)

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Monitoring
Remote Monitoring + Social Support
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 18 and 75 years old with HTN (ICD-10 code I10)
  • Has had at least two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with CKD or diabetes)
  • Must have a cellular phone with texting capabilities
  • Must be prescribed at least one medication for hypertension

Exclusion Criteria:

  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has congestive heart failure
  • Has dementia
  • Has liver cirrhosis

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Remote Monitoring (RM)

Remote Monitoring + Social Support (RM+SS)

Usual Care

Arm Description

Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence.

Remote Monitoring + Social Support subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence, as well as a social support partner to provide additional feedback to the participant on their monitoring and adherence practices.

Usual care subjects will not receive a blood pressure cuff or bidirectional text messaging. They will be asked to take their medication and monitor BP as usual with no additional contact from study staff until the 4 month study follow-up.

Outcomes

Primary Outcome Measures

Systolic blood pressure
Systolic blood pressure during the 4-month study visit, adjusted for initial systolic blood pressure

Secondary Outcome Measures

Percent of patients that are normotensive
The percent of patients with final blood pressure within the normal range.
Medication adherence
Medication adherence as measured by the text message response
Diastolic blood pressure
Adjusted for initial diastolic blood pressure

Full Information

First Posted
January 17, 2018
Last Updated
August 29, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03416283
Brief Title
Remote Monitoring and Social Support for Hypertension Management
Acronym
SupportBP
Official Title
Remote Monitoring and Enhanced Social Support for Hypertension Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
October 26, 2019 (Actual)
Study Completion Date
October 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control.
Detailed Description
The investigators plan to leverage the Way to Health (WTH) platform to develop and evaluate a new HTN service-delivery model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN: The investigators will assess the effects of monitoring blood pressure and medication adherence with feedback to the patient and to the clinical practice, as needed if out of control. The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Single (Investigator)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Monitoring (RM)
Arm Type
Experimental
Arm Description
Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence.
Arm Title
Remote Monitoring + Social Support (RM+SS)
Arm Type
Experimental
Arm Description
Remote Monitoring + Social Support subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence, as well as a social support partner to provide additional feedback to the participant on their monitoring and adherence practices.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care subjects will not receive a blood pressure cuff or bidirectional text messaging. They will be asked to take their medication and monitor BP as usual with no additional contact from study staff until the 4 month study follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Remote Monitoring
Intervention Description
Remote BP monitoring and medication adherence
Intervention Type
Behavioral
Intervention Name(s)
Remote Monitoring + Social Support
Intervention Description
Remote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading")
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure during the 4-month study visit, adjusted for initial systolic blood pressure
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Percent of patients that are normotensive
Description
The percent of patients with final blood pressure within the normal range.
Time Frame
4 months
Title
Medication adherence
Description
Medication adherence as measured by the text message response
Time Frame
4 months
Title
Diastolic blood pressure
Description
Adjusted for initial diastolic blood pressure
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 18 and 75 years old with HTN (ICD-10 code I10) Has had at least two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with CKD or diabetes) Must have a cellular phone with texting capabilities Must be prescribed at least one medication for hypertension Exclusion Criteria: Has metastatic (Stage IV) blood or solid tumor cancer Has end stage renal disease Has congestive heart failure Has dementia Has liver cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Monitoring and Social Support for Hypertension Management

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