N/A
N=121
Self-management of Blood Pressure Medication for Hypertensive Veterans
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03224624 ↗Enrolled (actual)
121
Serious AEs
21.9%
Results posted
Jul 2024
Primary outcome: Primary: In-clinic Blood Pressure Change — 136.0; 140.3; 126.9; 136.1 mm Hg — p=0.72
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- self-management protocol for hypertension care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-clinic Blood Pressure Change |
136.0; 140.3; 126.9; 136.1; -6.95; -5.60 | 0.72 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03224624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.