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Completed

NCT Number: NCT03416283

Remote Monitoring and Social Support for Hypertension Management

A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Monitoring

Behavioral

Remote BP monitoring and medication adherence

Remote Monitoring + Social Support

Behavioral

Remote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading")

Primary outcomes

  1. Systolic blood pressure

    Time frame: 4 months

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

Secondary outcomes

  1. Percent of patients that are normotensive

    Time frame: 4 months

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

  2. Medication adherence

    Time frame: 4 months

    Medication adherence as measured by the text message response

  3. Diastolic blood pressure

    Time frame: 4 months

    Adjusted for initial diastolic blood pressure

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Remote Monitoring and Enhanced Social Support for Hypertension Management

Acronym: SupportBP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2018
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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