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| ID | Type | Description | Link |
|---|---|---|---|
| HL130917 | Other Identifier | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMASH | Experimental | Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring |
|
| Enhanced SC | Other | No reminder functions on the pill monitoring device, attention control text messages |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMASH | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Meeting JNC8 Guidelines for BP Control | Percent of subjects meeting JNC8 Guidelines for BP control (<140/90) | 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. | Average across 6 mos.of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Months 1 and 6 |
| Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Chandler, PhD | MUSC College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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We will use 8 practice sites in each arm RCT design with clinic as unit of randomization and patient as unit of analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | SMASH | Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring SMASH Arm: 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. |
| FG001 | Enhanced SC | No reminder functions on the pill monitoring device, attention control text messages Enhanced SC Arm: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants were African American Adults with a sole diagnosis of uncontrolled hypertension
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| ID | Title | Description |
|---|---|---|
| BG000 | SMASH | Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring SMASH: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Subjects Meeting JNC8 Guidelines for BP Control | Percent of subjects meeting JNC8 Guidelines for BP control (<140/90) | Posted | Count of Participants | Participants | at 6 months at the end of intervention |
|
up to 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SMASH | Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring SMASH: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Chandler | Medical University of South Carolina | 843-792-1928 | chandlje@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2017 | Feb 26, 2018 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2017 | Feb 20, 2018 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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|
| Enhanced SC | Behavioral | 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. |
|
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. |
| 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) | 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) | 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. | Months 3,6 of intervention period and at months 6 and 12 of follow-up period. |
| BG001 | Enhanced SC | No reminder functions on the pill monitoring device, attention control text messages Enhanced SC: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Enhanced SC |
No reminder functions on the pill monitoring device, attention control text messages Enhanced SC: 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of participants | Average across 6 mos.of intervention |
|
|
|
| Secondary | 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) | Not Posted | Months 1 and 6 | Participants |
| Secondary | 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. | Not Posted | Jan 2050 | Month 6 of intervention period and at month 6 and 12 of follow-up period. | Participants |
| Secondary | Changes in Autonomous Motivation | Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36) | Not Posted | Months 3,6 of intervention period and at months 6 and 12 of follow-up period. | Participants |
| Secondary | 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) | Not Posted | Month 6 of intervention and months 6 and 12 of follow-up period | Participants |
| Secondary | Percent of Subjects Achieving and Maintaining Medication Adherence >.90. | Percent of subjects achieving and maintaining Medication Adherence >.90. | Not Posted | Months 3,6 of intervention period and at months 6 and 12 of follow-up period. | Participants |
| 0 |
| 97 |
| 0 |
| 97 |
| 0 |
| 97 |
| EG001 | Enhanced SC | No reminder functions on the pill monitoring device, attention control text messages Enhanced SC: 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. | 0 | 107 | 0 | 107 | 0 | 107 |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |