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Patient Centered Health Technology Medication Adherence Program for African American Hypertensives (SMASH)

Primary Purpose

Hypertension, Medication Non-Adherence

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMASH
Enhanced SC
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension

Eligibility Criteria

21 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. African American or Black, 21--59 years old
  2. Prescribed medication(s) only for HTN
  3. Medication possession ratio (MPR) <.85 for last 3 months
  4. 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
  5. 24--hour SBP ≥ 130 mmHg on clinic screening and subsequent recruitment evaluation
  6. Ability to speak, hear and understand English
  7. Able to take their own BP and self--administer medications
  8. Owns smart phone with data plan
  9. Primary care provider's assent that patient is able to participate

Exclusion Criteria:

  1. 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
  2. Beck Depression Inventory score >13
  3. Ongoing substance abuse (e.g., >21 drinks/week)
  4. Planned pregnancy
  5. Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SMASH

Enhanced SC

Arm Description

Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring

No reminder functions on the pill monitoring device, attention control text messages

Outcomes

Primary Outcome Measures

Percent of subjects meeting JNC8 Guidelines for BP control (<140/90)
Percent of subjects meeting JNC8 Guidelines for BP control (<140/90)
Percent of subjects with Medication Adherence to >.90.
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.

Secondary Outcome Measures

Changes in Medication Adherence Self-Efficacy
Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 13-52)
Percent Achieving and sustaining 24-hr BP control (< 130/80 mmHg)
24-hr ABP BP average SBP to (< 130/80 mmHg)
Changes in Autonomous Motivation
Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36)
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)
Percent of subjects achieving and maintaining Medication Adherence >.90.
Percent of subjects achieving and maintaining Medication Adherence >.90.

Full Information

First Posted
February 21, 2018
Last Updated
April 4, 2022
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03454308
Brief Title
Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
Acronym
SMASH
Official Title
Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Medication Non-Adherence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMASH
Arm Type
Experimental
Arm Description
Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
Arm Title
Enhanced SC
Arm Type
Other
Arm Description
No reminder functions on the pill monitoring device, attention control text messages
Intervention Type
Behavioral
Intervention Name(s)
SMASH
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced SC
Intervention Description
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 Outcome Measure Information:
Title
Percent of subjects meeting JNC8 Guidelines for BP control (<140/90)
Description
Percent of subjects meeting JNC8 Guidelines for BP control (<140/90)
Time Frame
at 6 months at the end of intervention
Title
Percent of subjects with Medication Adherence to >.90.
Description
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.
Time Frame
Average across 6 mos.of intervention
Secondary Outcome Measure Information:
Title
Changes in Medication Adherence Self-Efficacy
Description
Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 13-52)
Time Frame
Months 3,6, of intervention period and at months 12 and 18 during follow-up period.
Title
Percent Achieving and sustaining 24-hr BP control (< 130/80 mmHg)
Description
24-hr ABP BP average SBP to (< 130/80 mmHg)
Time Frame
Month 6 of intervention period and at month 6 and 12 of follow-up period.
Title
Changes in Autonomous Motivation
Description
Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36)
Time Frame
Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
Title
Percent of subject achieving and maintaining JNC8 Guidelines for BP control (<140/90)
Description
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
Title
Percent of subjects achieving and maintaining Medication Adherence >.90.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Chandler, PhD
Organizational Affiliation
MUSC College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Patient Centered Health Technology Medication Adherence Program for African American Hypertensives

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