Self-management of Blood Pressure Medication for Hypertensive Veterans
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | February 21, 2018 |
| End Date: | September 1, 2021 |
| Contact: | Dena E Rifkin, MD MS |
| Email: | dena.rifkin@va.gov |
| Phone: | (858) 855-8585 |
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.
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.
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
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
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
We found this trial at
2
sites
San Diego, California 92161
Principal Investigator: Dena Evette Rifkin, MD MS
Phone: (858) 855-8585
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San Francisco, California 94121
Phone: 415-221-4810
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