HypertensionSMASHNCT03454308
Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
A study testing SMASH and Enhanced SC in people with Hypertension and Medication Non-Adherence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This will be a two--arm Randomized controlled trial (RCT) design that will assess efficacy of the Smartphone Medication Adherence Stops Hypertension (SMASH) mobile health ( mHealth) program compared to an enhanced standard care (SC) program. Read more about this study
- Who is it for?
- Ages 21 to 59 years
- Conditions the study is for
- Hypertension, Medication Non-Adherence
- What is being tested?
- SMASH and Enhanced SC
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2017to 17 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- African American or Black, 21--59 years old
- Prescribed medication(s) only for HTN
- Medication possession ratio (MPR) <.85 for last 3 months
- uncontrolled HTN (SBP ≥130 mmHg) based upon last clinic visit within previous 12 months, initial clinic screening \& subsequent baseline recruitment evaluation following one month med intake screening with score of <.85
- 24--hour SBP ≥ 130 mmHg on clinic screening and subsequent recruitment evaluation
- Ability to speak, hear and understand English
Show all 9Show fewer
- Able to take their own BP and self--administer medications
- Owns smart phone with data plan
- Primary care provider's assent that patient is able to participate
Who cannot join
- No other known chronic disease (e.g., chronic kidney disease (GFR<50 mL/1.7 m2/min;; diabetes (type one or two) renal dialysis cancer diagnosis or treatment in past 2 years prior cv event such as heart attack, congestive heart failure, arterial stent, coronary artery bypass graft psychiatric illness
- Beck Depression Inventory score >13
- Ongoing substance abuse (e.g., >21 drinks/week)
- Planned pregnancy
- Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
This will be a two--arm Randomized controlled trial (RCT) design that will assess efficacy of the Smartphone Medication Adherence Stops Hypertension (SMASH) mobile health ( mHealth) program compared to an enhanced standard care (SC) program. Participants will be African-American (AA) hypertension patients with no other known chronic diseases.
Participants found to have uncontrolled hypertension (HTN) and medication non-adherence via electronic device monitoring will be randomized to SMASH or enhanced Standard Care (SC). The SMASH group will receive reminders in the form of auditory and visual reminders from a pill monitoring device when their medication dose is due, they will monitor their blood pressure at home and will receive tailored motivational text messages based upon levels of adherence . Enhanced SC group will use the pill monitoring device without reminder functions enabled and will receive text messages on topics of healthy lifestyles not related to medication adherence and hypertension.
The active intervention will continue for 6 months and follow-up will continue for 1 year.
Read the detailed description
192 AAs (21-59 yrs ) with uncontrolled HTN (no other comorbidities) and Medication Non-Adherence (MNA) will be recruited according to the inclusion and exclusion criteria found elsewhere. In the first phase of screening,resting BP protocols will be performed to determine hypertension is uncontrolled. Only subjects with verified uncontrolled HTN will proceed to the second screening phase .This is a 4 week medication monitoring phase using an electronic medication device with reminder alerts deactivated.Medication non-adherence (MNA) will be determined through medication possession ratio and by the timestamped intake adherence to their predesignated intake schedule across the 4 week period. MA score <0.85 over the 4-week screening and whose subsequent resting BP evaluations reconfirm uncontrolled HTN will be eligible for enrollment into the RCT.
SMASH subjects will have their pill monitor reminder functions activated, start receiving personalized motivational text messages and provided and instructed on use of a validated Bluetooth--enabled BP monitor used at home during the intervention period.
Enhanced SC subjects will continue to use the pill device with reminder functions disabled for another 6 months. In order to control for attention exposure SC subjects will be sent text messages on topics related to healthy lifestyle behaviors (diet, physical activity,no smoke exposure) but not related to Medication Adherence (MA) or HTN.
All subjects will complete 5 study visits where BP,medication possession ratios, and surveys will be completed. 24-hour Ambulatory Blood Pressure (ABP) monitoring will be performed every 6-months (4 times) during the study.
- Conditions
- Hypertension, Medication Non-Adherence
- Being tested
- SMASH, Enhanced SC
- 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.
SMASHBehavioural
Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers.
Enhanced SCBehavioural
Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control.
| Study group | Role | What they receive |
|---|---|---|
| SMASH | Experimental | Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring Receives: Behavioral: SMASH |
| Enhanced SC | Other | No reminder functions on the pill monitoring device, attention control text messages Receives: Behavioral: Enhanced SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects Meeting JNC8 Guidelines for BP Control
Percent of subjects meeting JNC8 Guidelines for BP control (<140/90)
Measured: at 6 months at the end of intervention
Percent of Participants* With Medication Adherence to >.90" as Accurate and Appropriate
Medication adherence >.90 using electronic medication intake devices. An algorithm is used which takes into account timing of dosage intakes using timestamped data from the devices.
Measured: Average across 6 mos.of intervention
Secondary outcomes (5)
Changes in Medication Adherence Self-Efficacy
Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 1-4)
Measured: Months 1 and 6
Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg)
24-hr ABP BP average SBP to (< 130/80 mmHg) - 0 participants with this data reported. Our technology team changed half way through the trial and our ability to use the 24 hour ambulatory monitors code that was built within our institution and transfer it to use with the external data team was unsuccessful.
Measured: Month 6 of intervention period and at month 6 and 12 of follow-up period.
Changes in Autonomous Motivation
Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36)
Measured: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
Percent of Subject Achieving and Maintaining JNC8 Guidelines for BP Control (<140/90)
Percent of subject achieving and maintaining JNC8 Guidelines for BP control (<140/90)
Measured: Month 6 of intervention and months 6 and 12 of follow-up period
Percent of Subjects Achieving and Maintaining Medication Adherence >.90.
Percent of subjects achieving and maintaining Medication Adherence >.90.
Measured: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start28 Apr 2017
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica L Chandler, PhD, Principal investigator, MUSC College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454308
- Sponsor's protocol ID
- 452
- Other IDs
- HL130917
- Acronym
- SMASH
- Status last verified
- Jun 2025
- First submitted
- 21 Feb 2018
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
- ClinicalTrials.gov ID
- NCT03454308
- Acronym / sponsor ID
- SMASH / 452
- Conditions
- Hypertension, Medication Non-Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a two--arm Randomized controlled trial (RCT) design that will assess efficacy of the Smartphone Medication Adherence Stops Hypertension (SMASH) mobile health ( mHealth) program compared to an enhanced standard care (SC) program. Participants will be African-American (AA) hypertension patients with no other known chronic diseases.
Participants found to have uncontrolled hypertension (HTN) and medication non-adherence via electronic device monitoring will be randomized to SMASH or enhanced Standard Care (SC). The SMASH group will receive reminders in the form of auditory and visual reminders from a pill monitoring device when their medication dose is due, they will monitor their blood pressure at home and will receive tailored motivational text messages based upon levels of adherence . Enhanced SC group will use the pill monitoring device without reminder functions enabled and will receive text messages on topics of healthy lifestyles not related to medication adherence and hypertension.
The active intervention will continue for 6 months and follow-up will continue for 1 year.
Detailed description
192 AAs (21-59 yrs ) with uncontrolled HTN (no other comorbidities) and Medication Non-Adherence (MNA) will be recruited according to the inclusion and exclusion criteria found elsewhere. In the first phase of screening,resting BP protocols will be performed to determine hypertension is uncontrolled. Only subjects with verified uncontrolled HTN will proceed to the second screening phase .This is a 4 week medication monitoring phase using an electronic medication device with reminder alerts deactivated.Medication non-adherence (MNA) will be determined through medication possession ratio and by the timestamped intake adherence to their predesignated intake schedule across the 4 week period. MA score <0.85 over the 4-week screening and whose subsequent resting BP evaluations reconfirm uncontrolled HTN will be eligible for enrollment into the RCT.
SMASH subjects will have their pill monitor reminder functions activated, start receiving personalized motivational text messages and provided and instructed on use of a validated Bluetooth--enabled BP monitor used at home during the intervention period.
Enhanced SC subjects will continue to use the pill device with reminder functions disabled for another 6 months. In order to control for attention exposure SC subjects will be sent text messages on topics related to healthy lifestyle behaviors (diet, physical activity,no smoke exposure) but not related to Medication Adherence (MA) or HTN.
All subjects will complete 5 study visits where BP,medication possession ratios, and surveys will be completed. 24-hour Ambulatory Blood Pressure (ABP) monitoring will be performed every 6-months (4 times) during the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMASH | Experimental | Behavioral: SMASHAutomated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring |
| Enhanced SC | Other | Behavioral: Enhanced SCNo reminder functions on the pill monitoring device, attention control text messages |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- African American or Black, 21--59 years old
- Prescribed medication(s) only for HTN
- Medication possession ratio (MPR) <.85 for last 3 months
- uncontrolled HTN (SBP ≥130 mmHg) based upon last clinic visit within previous 12 months, initial clinic screening \& subsequent baseline recruitment evaluation following one month med intake screening with score of <.85
- 24--hour SBP ≥ 130 mmHg on clinic screening and subsequent recruitment evaluation
Key exclusion criteria (5 listed)
- No other known chronic disease (e.g., chronic kidney disease (GFR<50 mL/1.7 m2/min;; diabetes (type one or two) renal dialysis cancer diagnosis or treatment in past 2 years prior cv event such as heart attack, congestive heart failure, arterial stent, coronary artery bypass graft psychiatric illness
- Beck Depression Inventory score >13
- Ongoing substance abuse (e.g., >21 drinks/week)
- Planned pregnancy
- Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.
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 |
|---|---|---|
| SMASHAuditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers. | Behavioural | SMASH |
| Enhanced SCAuditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control. | Behavioural | Enhanced SC |
Primary outcome
Percent of Subjects Meeting JNC8 Guidelines for BP Control
Time frame: at 6 months at the end of intervention
Percent of subjects meeting JNC8 Guidelines for BP control (<140/90)
Percent of Participants* With Medication Adherence to >.90" as Accurate and Appropriate
Time frame: Average across 6 mos.of intervention
Medication adherence >.90 using electronic medication intake devices. An algorithm is used which takes into account timing of dosage intakes using timestamped data from the devices.
5 secondary outcomes
Changes in Medication Adherence Self-Efficacy
Time frame: Months 1 and 6
Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg)
Time frame: Month 6 of intervention period and at month 6 and 12 of follow-up period.
Changes in Autonomous Motivation
Time frame: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
Percent of Subject Achieving and Maintaining JNC8 Guidelines for BP Control (<140/90)
Time frame: Month 6 of intervention and months 6 and 12 of follow-up period
Percent of Subjects Achieving and Maintaining Medication Adherence >.90.
Time frame: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jessica L Chandler, PhD principal investigator
MUSC College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMASH and Enhanced SC in people with Hypertension and Medication Non-Adherence, run by Medical University of South Carolina 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 13 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects Meeting JNC8 Guidelines for BP Control (time frame: at 6 months at the end of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.