HypertensionNCT01465217
Text Messaging to Improve Hypertension Medication Adherence in African Americans
A study testing text message medication reminders in people with Hypertension, run by Wayne State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- text message medication reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- be able to pay for and obtain hypertension medication
- English speaking
- willing to attend two data collection visits in Detroit, MI
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypertension
- Being tested
- text message medication reminders
- Keywords
- medication adherence, African Americans
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text message medication remindersBehavioural
daily medication reminders for one month
| Study group | Role | What they receive |
|---|---|---|
| text message medication reminders | Experimental | Not described Receives: Behavioral: text message medication reminders |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication adherence
Measured: one month
Secondary outcomes (2)
medication self efficacy
Measured: one month
blood pressure
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Lorraine Buis, Wayne State University
- Investigators
- Lorraine R Buis, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465217
- Sponsor's protocol ID
- 1R21HS019092-01
- Status last verified
- Dec 2014
- First submitted
- 1 Nov 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28148474Buis 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.
PubMed 25565680
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Improve Hypertension Medication Adherence in African Americans
- ClinicalTrials.gov ID
- NCT01465217
- Acronym / sponsor ID
- 1R21HS019092-01
- Conditions
- Hypertension
- Keywords
- medication adherence, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| text message medication reminders | Experimental | Behavioral: text message medication reminders |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| text message medication remindersdaily medication reminders for one month | Behavioural | text message medication reminders |
Primary outcome
medication adherence
Time frame: one month
2 secondary outcomes
medication self efficacy
Time frame: one month
blood pressure
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Derived from this study: PubMed 28148474Buis 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.
- Derived from this study: PubMed 25565680Buis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine R Buis, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing text message medication reminders in people with Hypertension, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication adherence (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465217, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.