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Text Messaging to Improve Hypertension Medication Adherence in African Americans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Wayne State University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lorraine Buis, Wayne State University
ClinicalTrials.gov Identifier:
NCT01465217
First received: November 1, 2011
Last updated: November 3, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: text message medication reminders

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Text Messaging to Improve Hypertension Medication Adherence in African Americans

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • medication adherence [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • medication self efficacy [ Time Frame: one month ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: text message medication reminders Behavioral: text message medication reminders
daily medication reminders for one month
No Intervention: control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465217

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Lorraine R Buis, PhD Wayne State University
  More Information

No publications provided

Responsible Party: Lorraine Buis, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01465217     History of Changes
Other Study ID Numbers: 1R21HS019092-01
Study First Received: November 1, 2011
Last Updated: November 3, 2011
Health Authority: United States: Agency for Healthcare Research and Quality

Keywords provided by Wayne State University:
medication adherence
African Americans

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014