A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting
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|ClinicalTrials.gov Identifier: NCT03986931|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Experimental: Pharmacist-Bidirectional Texting Group Other: Active Comparator: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Research interns conducting baseline and exit data collection will be blinded so that they do not influence responses.|
|Official Title:||A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting|
|Actual Study Start Date :||February 25, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||July 2022|
Experimental: Pharmacist-Bidirectional Texting Group
Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.
Other: Experimental: Pharmacist-Bidirectional Texting Group
The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
Active Comparator: Control Group
Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.
Other: Active Comparator: Control Group
This group will receive bidirectional texting, but no pharmacist monitoring.
- Change in Systolic Blood Pressure- 12 Months [ Time Frame: 12 months ]Change from baseline in systolic blood pressure in mm Hg at 12 months.
- Change in Diastolic Blood Pressure- 12 Months [ Time Frame: 12 months ]Change from baseline in diastolic blood pressure in mm Hg at 12 months.
- Number of Medication Changes in 12 Months [ Time Frame: 12 months ]Total number of medication changes (i.e., dose, discontinuation, initiation, etc.) from baseline as documented in the medical record.
- Dollars Spent per Patient for 12 Month Bidirectional Texting/Pharmacist Intervention [ Time Frame: 12 months ]Total cost of medications, time spent by research staff, and clinics visits per patient from baseline.
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): NCT03986931
|Contact: Linnea A Polgreen, PhD||(319) firstname.lastname@example.org|
|Contact: Shelby L Francis, PhD||(319) email@example.com|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Shelby L Francis, PhD 319-775-0689 firstname.lastname@example.org|
|Principal Investigator:||Linnea A Polgreen, PhD||University of Iowa|