Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Percent of Subjects Meeting JNC8 Guidelines for BP Control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
SMASH
Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
干预措施: SMASH (Behavioral)
Enhanced SC
No reminder functions on the pill monitoring device, attention control text messages
干预措施: Enhanced SC (Behavioral)
结局指标
主要结局
Percent of Subjects Meeting JNC8 Guidelines for BP Control
时间窗: 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
时间窗: 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.
次要结局
- Changes in Medication Adherence Self-Efficacy(Months 1 and 6)
- Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg)(Month 6 of intervention period and at month 6 and 12 of follow-up period.)
- Changes in Autonomous Motivation(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)(Month 6 of intervention and months 6 and 12 of follow-up period)
- 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.)