Text Messages and Blood Pressure Control

NCT02779231 | Completed

• 1 other identifier: 201509761
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension remains one of the most important preventable contributors to disease and death. It is the most common risk factor for strokes and myocardial infarctions in the U.S., and is associated with the greatest attributable risk for mortality among all modifiable risk factors for cardiovascular events. Over 50 million people are living with hypertension in the United States, and hypertension is one of the most common reasons for visits to a healthcare provider. Abundant evidence from randomized controlled trials has shown benefit of antihypertensive drug treatment in reducing important health outcomes in persons with hypertension. Yet, approximately 20% of U.S. adults are unaware that they have the disease. Hypertension is more difficult to diagnose than other common medical illnesses. In most cases, hypertension is asymptomatic; and accordingly patients do not seek care for it as they do for other common symptomatic illness. Patients are frequently diagnosed after presenting with end organ disease (e.g., myocardial infarctions, congestive heart failure, strokes, or renal failure). Another complicating aspect related to diagnosing uncontrolled hypertension is that multiple blood pressure measurements are needed to establish a diagnosis. Blood pressure readings can be falsely elevated in clinic due to the presence of an observer or the clinical surrounding (e.g., white coat hypertension). Even if an elevated blood pressure reading is identified in a clinic setting, more readings are needed in order to make it possible for physicians to decide about the next appropriate medical intervention. This need for multiple BP measurements over time often delays both initiating and modifying medical therapy for uncontrolled hypertension. Having patients take their BP at home facilitates the more timely diagnosis of uncontrolled hypertension by reducing diagnostic uncertainty. In fact, home measurements are better diagnostic indicators of stroke and cardiovascular mortality than clinic readings, are more closely correlated with end-organ damage, and are cost effective and well-tolerated by patients. Patients are frequently asked to record their BP after clinic visits. Historically, patients used a hand-written log, but more recently, patients are instructed to use an Internet-based web portal that uploads values to the patient's electronic medical record. Compliance with either approach relies on effective patient and provider followup, and in many settings, nurses or pharmacists will need to call patients to prompt them for their blood pressure measurements, which is both a costly and time consuming approach. Therefore, researchers need to develop effective, yet low cost alternatives to monitoring home blood pressure. This study proposes such a solution. The purpose of this study is to evaluate a simple m-health intervention to increase the ease and efficacy of diagnosing uncontrolled hypertension and achieve better blood pressure control in hypertensive patients.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• Patients' response to texting.

  The number of participants who completed the home blood pressure assignment will be compared between the two groups. These data will be extracted from the medical records for the standard of care group and from the "texting" website for the texting group.

  15 days

• Physicians' response to blood pressure information.

  The number of physicians who reacted to the blood pressure readings with any kind of clinical intervention (life style discussion, medication modification, ets.) will be compared between the two groups. These data will be extracted from the medical records.

  30 days

• Diagnosis rates between the text-messages and the standard of care groups.

  6 months

Secondary Outcomes (2)

• Time to intervention by physicians between the two groups

  30 days

• Difference in blood pressure reduction between the two groups

  6 months

Study Arms (2)

Texting group

EXPERIMENTAL

This group will be enrolled in bi-directional texting to send back blood pressure.

Other: Bi-directional texting

Standard of care group

NO INTERVENTION

Interventions

Bi-directional texting OTHER

Texting group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with at least one high blood pressure during any clinic visit over the past 6 months who owns cell phone with texting capability.
• Eligible participants will be asked the following screening questions:
• "Do you have a cell phone with text messaging ability?", and "are you willing to send your blood pressure numbers through text messages?". The participant should answer "yes" to both questions to be eligible for the study.

You may not qualify if:

• Active or acute mental health problem;
• Significant cognitive impairment;
• Lack of fluency in speaking or understanding English;
• Pregnancy.
• Also, If the participant answers "NO" to any one of the screening two questions, they will be excluded from the study.

Sponsors & Collaborators

• Linnea Polgreen: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Philip Polgreen, M.D. Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 20, 2016
• Study Start: September 1, 2015
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)