Self-management of Blood Pressure Medication for Hypertensive Veterans

• ClinicalTrials.gov Identifier: NCT03224624
• Recruitment Status: Active, not recruiting
• First Posted: July 21, 2017
• Last Update Posted: January 20, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: July 11, 2017
• First Posted Date: July 21, 2017
• Last Update Posted Date: January 20, 2022
• Actual Study Start Date: February 21, 2018
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 18, 2017)

in-clinic blood pressure change [ Time Frame: 1 year (end of intervention) ]

Blood pressure as measured in clinic at start and end of study

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 18, 2017)

24-hour ambulatory blood pressure change [ Time Frame: 1 year (start to end of intervention) ]

Home (24 hour) ambulatory blood pressure change measured from start to end of study

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 18, 2017)

• Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: 1 year ]
  Comparison of study-related adverse events in intervention vs. usual care arm. Events considered to be study-related include ER or urgent care visits for low or high blood pressure; hospitalizations related to low or high blood pressure; clinical events (hypertensive urgency, heart attack, stroke, syncope, death) related to high or low blood pressure.
• Intervention acceptability (patient-reported) [ Time Frame: 1 year ]
  acceptability of the intervention as measured by patient-reported scale of acceptability.
• Self-efficacy (patient-reported) [ Time Frame: 1 year ]
  Patients will report their hypertension-specific self-efficacy on a scale that will be repeated at start and end of study.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Self-management of Blood Pressure Medication for Hypertensive Veterans
• Official Title: Self-management of Blood Pressure Medication for Hypertensive Veterans

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.

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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Outcomes Assessor)
Masking Description:

The outcome (in clinic blood pressure) will be assessed without knowledge of which group participants were assigned.

Primary Purpose: Health Services Research

• Condition: Hypertension

Intervention

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.

Study Arms

• Experimental: self-management
  Participants will be taught to monitor blood pressure and make limited adjustments to their medications
  Intervention: Other: self-management protocol for hypertension care
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 19, 2022): 123
• Original Estimated Enrollment (submitted: July 18, 2017): 400
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03224624
• Other Study ID Numbers: IIR 15-369
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: de-identified data may be shared at end of study

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Same as current
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dena Evette Rifkin, MD MS; VA San Diego Healthcare System, San Diego, CA

• PRS Account: VA Office of Research and Development
• Verification Date: January 2022