- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01465217
Text Messaging to Improve Hypertension Medication Adherence in African Americans
December 15, 2014 updated by: Lorraine Buis, Wayne State University
Uncontrolled high blood pressure (HBP) is a major public health concern and leading cause of cardiovascular disease worldwide.
The HBP crisis is particularly onerous to African Americans as they are disproportionately more susceptible to HBP than non-Hispanic White Americans.
Poor adherence to prescribed medication regimens is a major problem, as only about half of patients who have been diagnosed with hypertension adhere to prescribed medications.
Mobile phones and text messages are becoming widely integrated into routine daily life and may offer a simple and non-labor intensive strategy for improving the quality of medication management through enhancing medication adherence.
This proposed research will be conducted in two distinct phases addressing three specific aims.
For Specific Aim 1 (Phase I), the investigators propose to conduct focus groups with participants from the investigators target population in order to obtain feedback to guide the development of a mobile phone text message system that seeks to improve adherence to antihypertensive medications.
For Specific Aim 2 (Phase II), the investigators propose to pilot test the newly developed text message intervention with a randomized controlled trial.
For Specific Aim 3 (Phase II), the investigators propose to ascertain participant perceptions of intervention effectiveness and satisfaction in order to guide further system refinement.
In Phase I, African Americans with uncontrolled hypertension (n=24-32) will be recruited to take part in one of four focus groups that will help guide the development of the text message intervention.
In Phase II, African Americans with uncontrolled hypertension will be randomized to receive usual care (n=30) vs. the text message intervention (n=30).
The primary outcome in this pilot will be change in medication adherence at one month follow-up; secondary outcomes include change in medication self-efficacy and systolic and diastolic blood pressure at one month follow-up, as well as participant satisfaction with the text message intervention.
The proposed research will utilize the Wayne State University (WSU) Center for Urban Studies to conduct high quality and professionally run focus groups, the WSU Division of Computing and Information Technology's Broadcast Message Service infrastructure for the delivery of text messages, the WSU Center for Health Research for statistical analysis and grant management assistance, and a diverse study team from a variety of disciplinary backgrounds at WSU.
As a result, the proposed research leverages the considerable local resources to investigate an innovative and much needed intervention for this high-risk population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Wayne State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- self-identify as African American/Black
- be >18 years
- have a diagnosis of HBP based on ICD-9 codes
- have uncontrolled hypertension on two successive clinic visits prior to screening (clinic SBP > 140 mm Hg, DBP > 90 mm Hg or SBP > 130, DBP > 80 for those with diabetes or kidney disease) as documented in the medical record
- be taking at least one antihypertensive medication
- own a cell phone capable of receiving and sending text messages
- be able to pay for and obtain hypertension medication
- English speaking
- willing to attend two data collection visits in Detroit, MI
Exclusion Criteria:
- receiving hemodialysis
- admits to planning to terminate cell phone contract during the next one month
- compliance risk (i.e., self-reported illicit drug use and/or alcohol abuse as measured by a score of >2 for CAGE questions
- health literacy less than third grade reading level
- other major health problems (e.g., terminal stage of cancer, advanced liver disease)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
|
|
|
Experimental: text message medication reminders
|
daily medication reminders for one month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
medication adherence
Time Frame: one month
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
medication self efficacy
Time Frame: one month
|
one month
|
|
blood pressure
Time Frame: one month
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lorraine R Buis, PhD, Wayne State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Buis L, Hirzel L, Dawood RM, Dawood KL, Nichols LP, Artinian NT, Schwiebert L, Yarandi HN, Roberson DN, Plegue MA, Mango LC, Levy PD. Text Messaging to Improve Hypertension Medication Adherence in African Americans From Primary Care and Emergency Department Settings: Results From Two Randomized Feasibility Studies. JMIR Mhealth Uhealth. 2017 Feb 1;5(2):e9. doi: 10.2196/mhealth.6630.
- Buis LR, Artinian NT, Schwiebert L, Yarandi H, Levy PD. Text Messaging to Improve Hypertension Medication Adherence in African Americans: BPMED Intervention Development and Study Protocol. JMIR Res Protoc. 2015 Jan 2;4(1):e1. doi: 10.2196/resprot.4040.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
November 1, 2011
First Submitted That Met QC Criteria
November 3, 2011
First Posted (Estimate)
November 4, 2011
Study Record Updates
Last Update Posted (Estimate)
December 16, 2014
Last Update Submitted That Met QC Criteria
December 15, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21HS019092-01 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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