SupportBP: Remote Monitoring and Social Support for Hypertension Management

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03416283
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 48.3
• Patients Per Site Per Month: 5.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: Remote Monitoring; Behavioral: Remote Monitoring + Social Support	N/A

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:

1. 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.

2. The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.

Study Design

• Study Type: Interventional
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Remote Monitoring and Enhanced Social Support for Hypertension Management
• Actual Study Start Date: May 20, 2018
• Actual Primary Completion Date: Oct 26, 2019
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remote Monitoring (RM) Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence.	Behavioral: Remote Monitoring; Remote BP monitoring and medication adherence
Experimental: Remote Monitoring + Social Support (RM+SS) 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.	Behavioral: Remote Monitoring + Social Support; Remote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading")
No Intervention: Usual Care 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.

Outcome Measures

Primary Outcome Measures

1. Systolic blood pressure [4 months]

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

Secondary Outcome Measures

1. Percent of patients that are normotensive [4 months]

   The percent of patients with final blood pressure within the normal range.

2. Medication adherence [4 months]

   Medication adherence as measured by the text message response

3. Diastolic blood pressure [4 months]

   Adjusted for initial diastolic blood pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Shivan Mehta, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03416283
• Other Study ID Numbers: 828417
• First Posted: Jan 31, 2018
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Dec 3, 2021