Self-management of Blood Pressure Medication for Hypertensive Veterans

ID: NCT03224624
Status: Recruiting
Phase: N/A
Start Date: February 21, 2018
First Submitted: July 11, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: VA Office of Research and Development
Location: United States
Conditions: Hypertension
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Study Description

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
Condition or disease Intervention/treatment Phase

Hypertension

Other: self-management protocol for hypertension care
Other Names
N/A

Tracking Information

First Submitted DateJuly 11, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateFebruary 21, 2018
Anticipated Completion DateSeptember 01, 2021
Actual Primary Completion DateJune 01, 2021
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

Not Available

Current Secondary Outcome Measures

  • 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

Not Available

Study Design

Brief TitleSelf-management of Blood Pressure Medication for Hypertensive Veterans
Official TitleSelf-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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
400
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Health Services Research
Conditions
Hypertension
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
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.

Other Names
Study Groups/Cohorts
self-management
Participants will be taught to monitor blood pressure and make limited adjustments to their medications

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.

Study Arms
Experimental self-management
Participants will be taught to monitor blood pressure and make limited adjustments to their medications
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.

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

Recruitment Information

Recruitment Status:Recruiting
Enrollment400
Completion DateSeptember 01, 2021
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 (currently > 150 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 > 1 antihypertensive agent
- 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03224624
Other Study ID Numbers
IIR 15-369
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
VA Office of Research and Development
Collaborators
Not Available
Investigators
Principal Investigator
Dena Evette Rifkin, MD MS
VA San Diego Healthcare System, San Diego, CA