Hypertension
Conditions
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
Interventions
OTHERself-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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome (in clinic blood pressure) will be assessed without knowledge of which group participants were assigned.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-clinic Blood Pressure Change | baseline compared to 6 months (mid-study) and 1 year (end of intervention) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability (Patient-reported) | 1 year | 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) |
| Self-efficacy (Patient-reported) | 1 year | 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? |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of 232 assessed, 111 did not randomize given inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| 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. | 60 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 9 | 4 |
Baseline characteristics
| Characteristic | Usual Care | Self-management | Total |
|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 12.7 | 62.8 years STANDARD_DEVIATION 10.5 | 63.0 years STANDARD_DEVIATION 11.6 |
| alcohol use current | 37 Participants | 38 Participants | 75 Participants |
| alcohol use former | 21 Participants | 14 Participants | 35 Participants |
| alcohol use never | 2 Participants | 6 Participants | 8 Participants |
| alcohol use unknown | 0 Participants | 1 Participants | 1 Participants |
| DBP at primary care visit | 82.7 mm Hg STANDARD_DEVIATION 9.1 | 85.1 mm Hg STANDARD_DEVIATION 8.4 | 83.87 mm Hg STANDARD_DEVIATION 8.81 |
| DBP at screening visit | 80.1 mm Hg STANDARD_DEVIATION 12.9 | 83.7 mm Hg STANDARD_DEVIATION 10.71 | 81.89 mm Hg STANDARD_DEVIATION 11.95 |
| Duration of hypertension (years) | 13.9 years STANDARD_DEVIATION 11.6 | 13.2 years STANDARD_DEVIATION 11.1 | 13.5 years STANDARD_DEVIATION 11.3 |
| Estimated GFR (creatinine-based) | 78.5 ml/min/1.73 M2 (CKD-EPI equation) STANDARD_DEVIATION 17.3 | 82.9 ml/min/1.73 M2 (CKD-EPI equation) STANDARD_DEVIATION 19 | 80.7 ml/min/1.73 M2 (CKD-EPI equation) STANDARD_DEVIATION 18.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 51 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 38 Participants | 37 Participants | 75 Participants |
| Region of Enrollment United States | 60 Participants | 59 Participants | 119 Participants |
| SBP at primary care visit | 148.2 mm Hg STANDARD_DEVIATION 11.5 | 147.0 mm Hg STANDARD_DEVIATION 13.2 | 147.59 mm Hg STANDARD_DEVIATION 12.33 |
| SBP at screening visit | 140.7 mm Hg STANDARD_DEVIATION 8.9 | 141.9 mm Hg STANDARD_DEVIATION 10 | 141.29 mm Hg STANDARD_DEVIATION 9.46 |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 59 Participants | 56 Participants | 115 Participants |
| Site VA San Diego | 43 Participants | 43 Participants | 86 Participants |
| Site VA San Francisco | 17 Participants | 16 Participants | 33 Participants |
| Smoking status current | 3 Participants | 6 Participants | 9 Participants |
| Smoking status former | 28 Participants | 24 Participants | 52 Participants |
| Smoking status never | 29 Participants | 29 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 59 | 0 / 60 |
| other Total, other adverse events | 3 / 59 | 5 / 60 |
| serious Total, serious adverse events | 14 / 59 | 12 / 60 |
Outcome results
Primary
In-clinic Blood Pressure Change
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.
Time frame: baseline compared to 6 months (mid-study) and 1 year (end of intervention)
Population: Participants seen in person for blood pressure evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-management | In-clinic Blood Pressure Change | mean DBP baseline | 80.5 mm Hg | Standard Deviation 10.4 |
| Self-management | In-clinic Blood Pressure Change | mean SBP baseline | 136.0 mm Hg | Standard Deviation 13.3 |
| Self-management | In-clinic Blood Pressure Change | mean DBP 12 month | 73.4 mm Hg | Standard Deviation 10.5 |
| Self-management | In-clinic Blood Pressure Change | difference in SBP baseline-12 month | -6.95 mm Hg | Standard Deviation 16.4 |
| Self-management | In-clinic Blood Pressure Change | DBP difference baseline-12 month | -5.51 mm Hg | Standard Deviation 10.7 |
| Self-management | In-clinic Blood Pressure Change | mean SBP 12-month | 126.9 mm Hg | Standard Deviation 13.8 |
| Usual Care | In-clinic Blood Pressure Change | DBP difference baseline-12 month | -1.76 mm Hg | Standard Deviation 12 |
| Usual Care | In-clinic Blood Pressure Change | mean SBP 12-month | 136.1 mm Hg | Standard Deviation 12.2 |
| Usual Care | In-clinic Blood Pressure Change | difference in SBP baseline-12 month | -5.60 mm Hg | Standard Deviation 17.6 |
| Usual Care | In-clinic Blood Pressure Change | mean DBP baseline | 78.7 mm Hg | Standard Deviation 13.1 |
| Usual Care | In-clinic Blood Pressure Change | mean DBP 12 month | 76.1 mm Hg | Standard Deviation 13.1 |
| Usual Care | In-clinic Blood Pressure Change | mean SBP baseline | 140.3 mm Hg | Standard Deviation 12.4 |
Comparison: t- tests were done to compare group mean differences between self-management and usual care and within groups Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.p-value: 0.72t-test, 2 sided
Comparison: Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.p-value: 0.15t-test, 2 sided
Comparison: change in SBP from baseline to 12-months within self-management group.p-value: 0.01t-test, 2 sided
Comparison: Comparing baseline-\>12month SBP change within usual care group.p-value: <0.05t-test, 2 sided
Comparison: change in DBP from baseline to 12-months within self-management group.p-value: <0.01t-test, 2 sided
p-value: 0.34t-test, 2 sided
Other Pre-specified
Intervention Acceptability (Patient-reported)
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)
Time frame: 1 year
Population: Participants in the intervention arm who answered program evaluation question at end of study (not asked in control arm).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-management | Intervention Acceptability (Patient-reported) | 7.74 units on a scale | Standard Deviation 2.83 |
Other Pre-specified
Self-efficacy (Patient-reported)
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?
Time frame: 1 year
Population: Everyone who completed 12 month questionnaire on self-efficacy in regard to blood pressure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-management | Self-efficacy (Patient-reported) | 7.59 score on a scale | Standard Deviation 2.74 |
| Usual Care | Self-efficacy (Patient-reported) | 5.04 score on a scale | Standard Deviation 3.68 |