N/A
Completed N=33
Connected Health Blood Pressure Monitoring In Stroke and TIA Patients
Stroke · Ischemic Attack, Transient
Source: ClinicalTrials.gov NCT02450760 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed — 40; 60 percentage of requested BP measurements — p=0.29
Summary
The goal of this pilot project is to assess adherence with home blood pressure monitoring in hypertensive patients with a history of cerebral infarction and to determine if a social incentive improves adherence with monitoring. Enrolled subjects will all have a history of cerebral infarction and uncontrolled blood pressure, defined by SBP>140 or DBP>90 mm Hg at the time of enrollment. To be eligible subjects will also be required to own a smart phone (iOS or Android operating system). After enrollment, patients will be given a home blood pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will be randomly assigned to a social incentive program, in which a social supporter receives updates via email and/or text message on the subject's adherence with BP monitoring and their average blood pressure. This study will provide important pilot data which will inform the design of future studies utilizing connected health and automated systems to improve home blood pressure monitoring and blood pressure control in patients with a history of stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed |
40; 60 | 0.29 |
| SECONDARY Change in Systolic Blood Pressure Over Study Period |
3.1; 2.7 | 0.95 |
| SECONDARY Number of Physician Visits |
2; 3 | — |
| SECONDARY Number of Emergency Department Visits |
0; 1 | — |
| SECONDARY Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent) |
0; 0 | — |
| SECONDARY Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use |
9; 9 | 0.15 |
| SECONDARY Number of Patients That Perceived Blood Pressure Monitoring to be Useful |
4; 3 | 0.83 |
| SECONDARY Number of Patients Who Felt They Had Well-controlled Blood Pressure |
10; 9 | 0.26 |
Eligibility Criteria
Inclusion Criteria
- Adult, age ≥ 18 years
- History of ischemic stroke or high risk TIA (defined by ABCD2 ≥ 4)between 2 weeks and 12 months prior to enrollment
- Hypertensive at time of enrollment, defined by SBP>140 mm Hg or DBP >90 mm Hg at the time of study screening
- Must own a smart phone capable of interacting with the connected blood pressure cuff (Apple iPhone 3GS or higher; Android 4.0 or higher with Bluetooth connectivity)
- Willingness and ability to sign informed consent by patient
Exclusion Criteria
- Moderate or severe disability, defined by modified Rankin Scale ≥ 3.
- Expected residence in a rehabilitation hospital, nursing facility or assisted living community during the study period.
- Upper arm circumference 17 inches
- Inability to monitor BP in both of the upper arms (i.e. history of bilateral radical mastectomy, bilateral severe subclavian stenosis, or bilateral arterial venous fistulas for dialysis).
- Blood pressure discrepancy between arms of >10 mm Hg.
- Inability to follow-up at 90 days and return BP monitor
- Active participation in another clinical trial
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT02450760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.