Self-management of Blood Pressure Medication for Hypertensive Veterans
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|ClinicalTrials.gov Identifier: NCT03224624|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : April 20, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: self-management protocol for hypertension care||Not Applicable|
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.
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|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|
|Official Title:||Self-management of Blood Pressure Medication for Hypertensive Veterans|
|Actual Study Start Date :||February 21, 2018|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
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.
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.
- in-clinic blood pressure change [ Time Frame: 1 year (end of intervention) ]Blood pressure as measured in clinic at start and end of study
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224624
|Contact: Dena E Rifkin, MD MS||(858) 855-8585 ext email@example.com|
|Contact: Joachim H Ix||(858) 642-1657||Joachim.Ix2@va.gov|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA||Recruiting|
|San Diego, California, United States, 92161|
|Contact: Dena E Rifkin, MD MS (858) 855-8585 ext 2784 firstname.lastname@example.org|
|Principal Investigator: Dena Evette Rifkin, MD MS|
|San Francisco VA Medical Center, San Francisco, CA||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Michael Shlipak, MD 415-221-4810 ext 23383 email@example.com|
|Contact: Erica Day, MPH 4152214810 ext 23383 firstname.lastname@example.org|
|Principal Investigator:||Dena Evette Rifkin, MD MS||VA San Diego Healthcare System, San Diego, CA|