Self-management of Blood Pressure Medication for Hypertensive Veterans

NCT03224624 | Completed Results DMC

• 1 other identifier: IIR 15-369
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

Other Outcomes (2)

• Intervention Acceptability (Patient-reported)

  1 year

• Self-efficacy (Patient-reported)

  1 year

Study Arms (2)

self-management

EXPERIMENTAL

Participants will be taught to monitor blood pressure and make limited adjustments to their medications

Other: self-management protocol for hypertension care

usual care

NO INTERVENTION

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.

Interventions

self-management protocol for hypertension care OTHER

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.

self-management

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Due to impact of COVID-19, recruitment was heavily impacted; repeated ambulatory blood pressure readings proved infeasible and that outcome is not available. The investigators report here the strict per protocol analysis of in person blood pressures.

Results Point of Contact

• Title: Dena Rifkin
• Organization: VA San Diego Healthcare System

dena.rifkin@va.gov

8585528585

Study Officials

• Dena Evette Rifkin, MD MS

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome (in clinic blood pressure) will be assessed without knowledge of which group participants were assigned.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either usual care or self-management of blood pressure using a stepped approach which participants can trigger using their home blood pressure measures.

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 21, 2017
• Study Start: February 21, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 2, 2025
• Results First Posted: July 18, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)