N/A
N=488
Reach Out: Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03422718 ↗Enrolled (actual)
488
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Mean Systolic Blood Pressure — 142.8; 146.8; 143.9; 144.7 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Healthy Behavior Texts (Behavioral); No healthy behavior texts (Behavioral); BP Monitoring Daily Via Text Messaging (Behavioral); BP Monitoring Weekly Via Text Messaging (Behavioral); Physician appointment and transportation scheduling (Behavioral); No physician appointment and transportation scheduling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Systolic Blood Pressure |
142.8; 146.8; 143.9; 144.7; 148; 145.8 | — |
| SECONDARY Hazard Ratio Analysis of Participant Time From Enrollment Emergency Department Visit to the First PCP Visit |
0.9; 1.2; 1.2 | — |
| SECONDARY Odds Ratio Analysis of Participants Completing 2 or More Primary Care Visits |
0.7; 1.8; 1.7 | — |
Summary
This study evaluates a health theory based mobile health behavioral intervention to reduce blood pressure (BP) among hypertensive patients evaluated in a community Emergency Department (ED) setting.
Eligibility Criteria
Inclusion Criteria
- Age of 18 or greater
- At least one BP with Systolic Blood Pressure (SBP) ≥ 160 or a Diastolic Blood Pressure (DBP) ≥ 100 (criteria 1)
- If the patient has repeated measurements after achieving Criteria 1, at least one of the repeat BP remains SBP ≥ 140 or a DBP ≥ 90
- Must have cell phones with text-messaging capability and willingness to receive texts
- Likely to be discharged from the ED
Exclusion Criteria
- Unable to read English (<1% at study site)
- Prisoners
- Pregnant
- Pre-existing condition making one year follow-up unlikely
- Terminal illness with death expected within 90 days
- Current use of 3 or more antihypertensive agents
- Patients with other serious medical conditions that prevent self-monitoring of BP
- Critical illness with placement in resuscitation bay
- Dementia/cognitive impairment
Data sourced from ClinicalTrials.gov (NCT03422718). 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.