Clinical trial NCT03224624: Self-management of Blood Pressure Medication for Hypertensive Veterans
Official title: Self-management of Blood Pressure Medication for Hypertensive Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-07-21
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: In-clinic Blood Pressure Change
timeFrame: baseline compared to 6 months (mid-study) and 1 year (end of intervention)
Secondary outcomes:
Other outcomes:
measure: Intervention Acceptability (Patient-reported)
timeFrame: 1 year
measure: Self-efficacy (Patient-reported)
timeFrame: 1 year
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Dena Evette Rifkin, MD MS
role: PRINCIPAL_INVESTIGATOR
References: