Self-management of Blood Pressure Medication for Hypertensive Veterans

Hypertension is the most common medical problem among US Veterans. Treatment is available and effective, but control rates remain under 75%. While blood pressure control has traditionally been achieved through sequential visits and medication changes initiated by providers during office-based care, self-monitoring and self-management of blood pressure medication is an important strategy that would empower Veterans to achieve better control of blood pressure. The health impacts of better systems for treatment of hypertension are significant, including decreased rates of cardiovascular and kidney disease.

This two-site clinical trial will randomize 400 Veterans to either usual blood pressure care or a self-management strategy in which patient-driven self-management of blood pressure medications will be taught and used over the course of 1 year.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: self-management protocol for hypertension care

Detailed Description

Project background: Recent literature from the UK (TASMIN2 and TASMIN-SR trials) have suggested that patient-driven self-management of blood pressure medications can be effective in achieving hypertension control, but questions remain as to how to apply these findings to a US population. The VA Healthcare System is an ideal system in which to test and customize this strategy for blood pressure treatment.

Project question:

Is patient-initiated self-management of blood pressure medication using a pre-specified, generalizable dose escalation scheme clinically effective, safe, and acceptable to patients and clinicians, compared to usual care in controlling blood pressure in hypertensive Veterans? Project methods: The investigators propose a 12-month randomized, controlled, non-blinded, single-center study of patient-initiated self-management of blood pressure medication vs. usual care with planned post study cohort follow-up via medical records. Participants in the intervention arm will be provided with home blood pressure monitoring tools and a self-management algorithm for changing their blood pressure medications as needed. Participants in the usual care arm will receive home monitoring tools and typical hypertension care from the primary care provider. The primary blood pressure outcome measure for the study will be between-group change in in-clinic blood pressure. Acceptability, safety, patient-centered outcomes and adherence will be key secondary outcomes

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • VA San Diego Healthcare System, San Diego, CA
    • San Francisco, California, United States, 94121
      • San Francisco VA Medical Center, San Francisco, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible participants are those with who have a clinical diagnosis of hypertension
• Who are not currently at their in-clinic goal blood pressure (>130 or > 90 at minimum)
• Are able to provide independent informed consent and expected to be in the area for at least 12 months

Exclusion Criteria:

• Criteria for exclusion will include: active prescriptions for > 2 antihypertensive agents
• Known allergies to 2 or more antihypertensive agents

• Currently not primarily in charge of his/her own medication administration, e.g.:

  • those living in institutions or with dementia or other limitations making self medication care not possible
• Life expectancy of less than 12 months
• Blood pressure at screening visit > 180 mm Hg systolic or > 110 diastolic, or < 120 systolic
• Screening cognitive function (Montreal Assessment of Cognitive Function, MoCA) 48 score less than 25
• eGFR < 25 ml/min /1.73m2 or end-stage renal disease (ESRD)
• Inability to use a standard home blood pressure cuff
• Known secondary cause of hypertension that causes concern regarding safety of the protocol, in the opinion of the site investigator
• Cardiovascular event or hospitalization for unstable angina within last 3 months
• Symptomatic heart failure within the past 6 months or left ventricular ejection fraction < 35%
• Pregnancy or planned pregnancy, or of child-bearing age not using birth control
• Current participation in another clinical trial

• Or major factors judged to be likely to significantly limit comprehension of or adherence to interventions including:

  • dementia
  • psychiatric disease
  • substance abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: self-management; Participants will be taught to monitor blood pressure and make limited adjustments to their medications	Other: self-management protocol for hypertension care; participants in this arm will be taught to monitor and record their blood pressure. On a regular basis they will evaluate their blood pressure record and follow an algorithm to decide whether to adjust their medication.
No Intervention: usual care; Participants will be enrolled in the study and undergo a baseline, 6 month, and 1 year visit but their hypertension care will be per usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-clinic Blood Pressure Change	Blood pressure as measured in clinic at start and end of study. **Due to COVID, a more limited number of participants were seen in person at end of study. Study protocol was modified to collect data by phone and via chart as well when in-person data collection was not feasible. Here, we report the strict definition and numbers seen in person as per the primary protocol.	baseline compared to 6 months (mid-study) and 1 year (end of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour ambulatory blood pressure change	Home (24 hour) ambulatory blood pressure change measured from start to end of study	1 year (start to end of intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability (Patient-reported)	Acceptability of the intervention as measured by patient-reported scale of acceptability. On a scale from 1 to 10, how likely would you be to continue such a program? Please select a number. (0= very unlikely, 5 = average, 10 = likely)	1 year
Self-efficacy (Patient-reported)	Patients will report their hypertension-specific self-efficacy on a scale that will be repeated at start and end of study. On a scale of 1-10 (very unconfident to very confident). "How confident are you that you can titrate or adjust your blood pressure?"	1 year

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Dena Evette Rifkin, MD MS, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2018
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: IIR 15-369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data may be shared at end of study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No