Trial Outcomes & Findings for Self-management of Blood Pressure Medication for Hypertensive Veterans (NCT NCT03224624)

Last Updated: 2025-05-02

Results Overview

Blood pressure as measured in clinic at start and end of study. \*\*Due to COVID, a more limited number of participants were seen in person at end of study. Study protocol was modified to collect data by phone and via chart as well when in-person data collection was not feasible. Here, we report the strict definition and numbers seen in person as per the primary protocol.

Recruitment status

COMPLETED

Study phase

Target enrollment

232 participants

Primary outcome timeframe

baseline compared to 6 months (mid-study) and 1 year (end of intervention)

Results posted on

2025-05-02

Participant Flow

Participants were recruited from opt-out letters, referrals, and advertisement. After consent, participants were assessed for eligibility by review of inclusion/exclusion criteria including BP at the screening visit as well as cognitive assessment.

Of 232 assessed, 111 did not randomize given inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Self-management Participants will be taught to monitor blood pressure and make limited adjustments to their medications 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.	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.
Overall Study STARTED	60	61
Overall Study Baseline Visit	59	60
Overall Study 6 Month Visit Completed	50	55
Overall Study COMPLETED	50	57
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Self-management Participants will be taught to monitor blood pressure and make limited adjustments to their medications 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.	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.
Overall Study Lost to Follow-up	9	4
Overall Study Death	1	0

Baseline Characteristics

Self-management of Blood Pressure Medication for Hypertensive Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-management n=59 Participants Participants will be taught to monitor blood pressure and make limited adjustments to their medications 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.	Usual Care n=60 Participants 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.	Total n=119 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 10.5 • n=99 Participants	63.3 years STANDARD_DEVIATION 12.7 • n=107 Participants	63.0 years STANDARD_DEVIATION 11.6 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	56 Participants n=99 Participants	59 Participants n=107 Participants	115 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=99 Participants	53 Participants n=107 Participants	104 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Black or African American	12 Participants n=99 Participants	11 Participants n=107 Participants	23 Participants n=206 Participants
Race (NIH/OMB) White	37 Participants n=99 Participants	38 Participants n=107 Participants	75 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Region of Enrollment United States	59 Participants n=99 Participants	60 Participants n=107 Participants	119 Participants n=206 Participants
Site VA San Diego	43 Participants n=99 Participants	43 Participants n=107 Participants	86 Participants n=206 Participants
Site VA San Francisco	16 Participants n=99 Participants	17 Participants n=107 Participants	33 Participants n=206 Participants
SBP at primary care visit	147.0 mm Hg STANDARD_DEVIATION 13.2 • n=99 Participants	148.2 mm Hg STANDARD_DEVIATION 11.5 • n=107 Participants	147.59 mm Hg STANDARD_DEVIATION 12.33 • n=206 Participants
DBP at primary care visit	85.1 mm Hg STANDARD_DEVIATION 8.4 • n=99 Participants	82.7 mm Hg STANDARD_DEVIATION 9.1 • n=107 Participants	83.87 mm Hg STANDARD_DEVIATION 8.81 • n=206 Participants
SBP at screening visit	141.9 mm Hg STANDARD_DEVIATION 10.0 • n=99 Participants	140.7 mm Hg STANDARD_DEVIATION 8.9 • n=107 Participants	141.29 mm Hg STANDARD_DEVIATION 9.46 • n=206 Participants
DBP at screening visit	83.7 mm Hg STANDARD_DEVIATION 10.71 • n=99 Participants	80.1 mm Hg STANDARD_DEVIATION 12.9 • n=107 Participants	81.89 mm Hg STANDARD_DEVIATION 11.95 • n=206 Participants
alcohol use current	38 Participants n=99 Participants	37 Participants n=107 Participants	75 Participants n=206 Participants
alcohol use former	14 Participants n=99 Participants	21 Participants n=107 Participants	35 Participants n=206 Participants
alcohol use never	6 Participants n=99 Participants	2 Participants n=107 Participants	8 Participants n=206 Participants
alcohol use unknown	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Smoking status current	6 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants
Smoking status former	24 Participants n=99 Participants	28 Participants n=107 Participants	52 Participants n=206 Participants
Smoking status never	29 Participants n=99 Participants	29 Participants n=107 Participants	58 Participants n=206 Participants
Estimated GFR (creatinine-based)	82.9 ml/min/1.73 M2 (CKD-EPI equation) STANDARD_DEVIATION 19.0 • n=99 Participants	78.5 ml/min/1.73 M2 (CKD-EPI equation) STANDARD_DEVIATION 17.3 • n=107 Participants	80.7 ml/min/1.73 M2 (CKD-EPI equation) STANDARD_DEVIATION 18.2 • n=206 Participants
Duration of hypertension (years)	13.2 years STANDARD_DEVIATION 11.1 • n=99 Participants	13.9 years STANDARD_DEVIATION 11.6 • n=107 Participants	13.5 years STANDARD_DEVIATION 11.3 • n=206 Participants

PRIMARY outcome

Timeframe: baseline compared to 6 months (mid-study) and 1 year (end of intervention)

Population: Participants seen in person for blood pressure evaluation.

Outcome measures

Outcome measures
Measure	Self-management n=59 Participants Participants will be taught to monitor blood pressure and make limited adjustments to their medications 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.	Usual Care n=60 Participants 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 mean SBP 12-month	126.9 mm Hg Standard Deviation 13.8	136.1 mm Hg Standard Deviation 12.2
In-clinic Blood Pressure Change mean SBP baseline	136.0 mm Hg Standard Deviation 13.3	140.3 mm Hg Standard Deviation 12.4
In-clinic Blood Pressure Change difference in SBP baseline-12 month	-6.95 mm Hg Standard Deviation 16.4	-5.60 mm Hg Standard Deviation 17.6
In-clinic Blood Pressure Change mean DBP baseline	80.5 mm Hg Standard Deviation 10.4	78.7 mm Hg Standard Deviation 13.1
In-clinic Blood Pressure Change mean DBP 12 month	73.4 mm Hg Standard Deviation 10.5	76.1 mm Hg Standard Deviation 13.1
In-clinic Blood Pressure Change DBP difference baseline-12 month	-5.51 mm Hg Standard Deviation 10.7	-1.76 mm Hg Standard Deviation 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Participants in the intervention arm who answered program evaluation question at end of study (not asked in control arm).

Acceptability of the intervention as measured by patient-reported scale of acceptability. On a scale from 1 to 10, how likely would you be to continue such a program? Please select a number. (0= very unlikely, 5 = average, 10 = likely)

Outcome measures

Outcome measures
Measure	Self-management n=50 Participants Participants will be taught to monitor blood pressure and make limited adjustments to their medications 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.	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.
Intervention Acceptability (Patient-reported)	7.74 units on a scale Standard Deviation 2.83	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Everyone who completed 12 month questionnaire on self-efficacy in regard to blood pressure

Patients will report their hypertension-specific self-efficacy on a scale that will be repeated at start and end of study. On a scale of 1-10 (very unconfident to very confident). "How confident are you that you can titrate or adjust your blood pressure?"

Outcome measures

Outcome measures
Measure	Self-management n=47 Participants Participants will be taught to monitor blood pressure and make limited adjustments to their medications 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.	Usual Care n=54 Participants 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.
Self-efficacy (Patient-reported)	7.59 score on a scale Standard Deviation 2.74	5.04 score on a scale Standard Deviation 3.68

Adverse Events

Self-management

Serious events: 14 serious events

Other events: 3 other events

Deaths: 1 deaths

Usual Care

Serious events: 12 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Self-management n=59 participants at risk Participants will be taught to monitor blood pressure and make limited adjustments to their medications 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.	Usual Care n=60 participants at risk 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.
Surgical and medical procedures Hospitalization (surgical, planned)	3.4% 2/59 • Number of events 2 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	8.3% 5/60 • Number of events 5 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Infections and infestations Infection requiring hospitalization	1.7% 1/59 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	5.0% 3/60 • Number of events 3 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Gastrointestinal disorders Gastrointestinal disease requiring hospitalization	6.8% 4/59 • Number of events 4 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	1.7% 1/60 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Endocrine disorders Diabetic ketoacidosis requiring hospitalization	3.4% 2/59 • Number of events 2 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	0.00% 0/60 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Blood and lymphatic system disorders pulmonary embolism requiring hospitalization	0.00% 0/59 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	1.7% 1/60 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Cardiac disorders atrial fibrillation requiring hospitalization	0.00% 0/59 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	1.7% 1/60 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Cardiac disorders Stroke requiring hospitalization	1.7% 1/59 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	1.7% 1/60 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Psychiatric disorders Psychiatric disease requiring hospitalization	1.7% 1/59 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	0.00% 0/60 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Injury, poisoning and procedural complications drug toxicity requiring hospitalization	1.7% 1/59 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	0.00% 0/60 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Ear and labyrinth disorders vertigo (BPPV) requiring hospitalization	1.7% 1/59 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	0.00% 0/60 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
General disorders injurious fall requiring hospitalization	1.7% 1/59 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	0.00% 0/60 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.

Other adverse events

Other adverse events
Measure	Self-management n=59 participants at risk Participants will be taught to monitor blood pressure and make limited adjustments to their medications 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.	Usual Care n=60 participants at risk 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.
Cardiac disorders Hypertension evaluted in emergency department	1.7% 1/59 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	1.7% 1/60 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Cardiac disorders Chest pain evaluated in emergency department	3.4% 2/59 • Number of events 2 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	3.3% 2/60 • Number of events 2 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Cardiac disorders syncope evaluated in emergency department	0.00% 0/59 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	1.7% 1/60 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.
Immune system disorders Drug-associated angioedema, evaluated in emergency department	0.00% 0/59 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.	1.7% 1/60 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12 month visit. Adverse event collection included adverse events of special interest, as reported below, regarding emergency department visits for problems potentially related to hypertension.

Additional Information

Dena Rifkin

VA San Diego Healthcare System

Phone: 8585528585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place