Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

Официальное название

Mobile Cued Adherence Therapy (mCAT): A Scalable Habit Formation Intervention to Improve Blood Pressure Medication Adherence Based on a Widely Used Smartphone App

Обзор

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.

Вмешательства

• Поведенческое Wellth App
  Participants will be eligible to receive $30 at the end of four consecutive 30-day periods ($120 in total) if they demonstrate complete medication adherence through the Wellth app (i.e. taking a daily picture of their pills in their hand and submitting it through the Wellth app). Photos must be submitted within a 2-hour window around a specific time of day chosen by the participant and set at the start of each 30-day period. They will lose $2 (from their $30 total) for every day they miss a medi
• Поведенческое Action Planning
  Participants will learn about habits and the importance of contextual cues for triggering their AH pill taking, and be asked to complete an electronic worksheet with a detailed description of their personalized contextual cue in terms of its: 1) location (e.g., where in the participant's house or office does this cue occur); 2) time of day; 3) preceding action (e.g., "I usually go to the bathroom before making coffee"); and 4) a visual cue (e.g., "my coffee cup will trigger pill taking").
• Поведенческое Wellth + Cue
  Participants will be eligible to receive $30 at the end of four consecutive 30-day periods ($120 in total) if they submit daily evidence of their medication adherence habit using the Wellth app (i.e. one photo that provides evidence of pill-taking and one photo that provides evidence of their contextual cue, which participants will select and specify on their comprehension survey at the start of the study). Photos must be submitted within a 2-hour window around a specific time of day chosen by t

Первичные конечные точки

• Medication Adherence [Срок оценки: 24 months prior to the study through the 24-month study period]
• Cardiovascular Health [Срок оценки: Baseline, after the 4-month intervention, 8-month follow-up, 12-month follow-up, and 24-month follow-up]

Вторичные конечные точки (1)

• Healthcare Utilization and Costs [Срок оценки: 24 months prior to the study through the 24-month study period]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Wellth Inc. — Los Angeles

Идентификаторы

NCT: NCT06876233 · STUDY00020282 · R01HL171706

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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