Mobile Cued Adherence Therapy (mCAT): A Scalable Habit Formation Intervention to Improve Blood Pressure Medication Adherence Based on a Widely Used Smartphone App
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Cardiovascular Health
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of a novel mobile health-based habit formation intervention for increasing and maintaining adherence to anti-hypertensive (AH) medication among people living with hypertension and indicate medication nonadherence. The main questions it aims to answer are:
- Can daily incentives for AH pill taking increase and maintain AH medication adherence, control blood pressure, and reduce healthcare utilization and costs?
- Can daily incentives for AH pill taking, combined with action planning (e.g., "After I drink my morning coffee, I will take my medication.") increase and maintain medication adherence, control blood pressure, and reduce healthcare utilization and costs?
- What aspects of daily incentives and/or action planning do participants find most helpful or effective for AH medication adherence?
- What barriers exist for participants who receive daily incentives and/or action planning?
Researchers will compare three study groups: those who only receive daily incentives for the AH pill taking, those who receive daily incentives for AH pill taking combined with action planning, and a control group (who do not receive daily incentives for AH pill taking or action planning). By comparing these three groups, the researchers will be able to determine the effectiveness of the daily incentives with or without action planning for promoting long-term AH medication adherence, reduce healthcare costs, and improve blood pressure.
Participants will:
- Complete 5 online surveys over the course of 2 years (baseline, month 4, month 8, month 12, month 24).
- Submit blood pressure reading for 7 consecutive days after each survey timepoint.
- Submit photo evidence of their AH pill taking for 4 months (intervention groups only).
The highest- and lowest-performing participants in each intervention group will also be invited to complete a 30-minute interview to identify additional factors that contributed to either successful or unsuccessful completion of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Aged 18 years or older
- •Currently diagnosed with hypertension (either stage I or stage II hypertension)
- •Able to read/write/understand English
- •Have daily access to a smartphone
- •Engaged in hypertension care: Already been prescribed hypertension medication for a minimum of 6 months at the time of study enrollment
- •Demonstrated AH medication nonadherence by having over 73 days without documented AH medication prescription coverage (observable in Arizona Health Care Cost Containment System (AHCCCS) prescription drugs claims) in the past 12 months (i.e. <80% mean adherence)
排除标准
- 未提供
研究组 & 干预措施
Control
Control participants will receive SMS reminders of each assessment point and monthly two-way SMS messages to provide AH pill-taking tips and to ask if participants are feeling dizziness or other symptoms of low blood pressure. Participants in the control group will not receive additional adherence reminders, financial incentives, or the Wellth app during the 24-month study.
Wellth only
Participants in the Wellth only group will receive daily financial incentives during the 4-month intervention for providing photo evidence of their pill taking using the mobile app Wellth (i.e. taking a daily picture of their pills in their hand and submitting it through the Wellth app). The Wellth app will also provide reminders at the end of the day if participants have not yet completed their daily check-in. Participants will also receive SMS reminders of each assessment point and monthly two-way SMS messages to provide AH pill-taking tips and to ask if participants are feeling dizziness or other symptoms of low blood pressure.
干预措施: Wellth App (Behavioral)
Wellth + Cue
Participants in the Wellth+Cue group will receive daily financial incentives during the 4-month intervention for providing photo evidence of their pill taking using the mobile app Wellth (i.e. taking a daily picture of their pills in their hand and submitting it through the Wellth app), conditional on using their action plan. The Wellth app will also provide reminders at the end of the day if participants have not yet completed their daily check-in. Participants will also receive SMS reminders of each assessment point and monthly two-way SMS messages to provide AH pill-taking tips and to ask if participants are feeling dizziness or other symptoms of low blood pressure.
干预措施: Wellth + Cue (Behavioral)
Wellth + Cue
Participants in the Wellth+Cue group will receive daily financial incentives during the 4-month intervention for providing photo evidence of their pill taking using the mobile app Wellth (i.e. taking a daily picture of their pills in their hand and submitting it through the Wellth app), conditional on using their action plan. The Wellth app will also provide reminders at the end of the day if participants have not yet completed their daily check-in. Participants will also receive SMS reminders of each assessment point and monthly two-way SMS messages to provide AH pill-taking tips and to ask if participants are feeling dizziness or other symptoms of low blood pressure.
干预措施: Action Planning (Behavioral)
结局指标
主要结局
Cardiovascular Health
时间窗: Baseline, after the 4-month intervention, 8-month follow-up, 12-month follow-up, and 24-month follow-up
All participants will be asked to submit blood pressure readings for seven consecutive days after baseline activities, and be reminded via SMS and email to submit readings after the 4-month intervention and again after the month 8, 12, and 24 assessments. The investigators will calculate the Primary Outcome measure of blood pressure as participants' mean and coefficient of variation in systolic and diastolic blood pressure over the seven-day interval.
Medication Adherence
时间窗: 24 months prior to the study through the 24-month study period
The investigators will use Medicaid's prescription data to construct the Primary Outcome of AH medication adherence using the date and supply of pills for each new prescription or refill to determine the number of days in a month a client had pills available. Since refills are often made before an existing prescription ends, the supply of new medications will be counted on days following the last available dose of the prior prescription. The number of days with available AH medication(s) will be divided by the total number of days in the same month to calculate the proportion of days covered (PDC), which will range from 0 and 1.
次要结局
- Healthcare Utilization and Costs(24 months prior to the study through the 24-month study period)
研究者
Chad Stecher@asu.edu
Associate Professor
Arizona State University