Mobile Health Intervention to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Self-Reported Medication Adherence
研究概览
简要总结
Background: Adolescents and young adults (AYAs) with chronic illnesses often struggle to develop illness self-management skills. Mobile health (mHealth) interventions have been developed for some specific chronic illnesses, but flexible interventions that can be generalized across conditions are needed to accelerate translation.
Research Hypotheses: 1) Cell phone support (CPS) will increase medication adherence and self-management skills across a variety of health conditions; 2) CPS delivered by text message will outperform CPS delivered by phone calls; 3) Patients' perceptions of the human adherence facilitator (AF) will differ based on the mode of communication, text message versus phone calls.
Design: A randomized, controlled, 3-arm pilot trial, following community-based participatory research (CBPR) principles, will test the impact of AF delivered by phone calls or text messages on medication adherence and illness self-management. Conditions will be CPS delivered by phone calls, CPS delivered by text messages, or usual care.
Participants: Participants will include AYAs with diverse chronic illnesses aged 15-20 years (N = 60).
Methods: This study will involve piloting CPS via different communication modes in a randomized trial, informed by CBPR principles. Questionnaires and focus groups will be used to understand how patients perceive the intervention and adherence facilitator.
Main Outcome Measures: Outcomes will include medication and appointment adherence, pharmacy refill ratios, self-management skills, and perceptions of the AF.
Innovation: This study will provide new knowledge regarding how to promote illness self-management skills, and may result in an mHealth intervention with the potential to widely impact supportive care for AYAs with chronic illnesses.
详细描述
The aim of this randomized pilot trial is to evaluate the acceptability, feasibility, and efficacy of CPS delivered by phone calls or text messages to AYAs with two distinct chronic illnesses, in preparation for an R01 proposal to conduct a multisite, effectiveness-implementation hybrid trial. We propose 1) assessing the feasibility, acceptability, and efficacy of CPS for improving medication adherence, 2) investigating the impact of delivering CPS through live text messages versus phone calls using quantitative and qualitative methods, and 3) evaluating patient and provider views of CPS to guide future implementation work. The proposed research follows the conceptual model, illustrated below, positing that CPS will promote adherence through engaging AYAs in calls or texts with a human AF providing social support. We predict that delivering CPS by text message will increase feasibility and acceptability, perceived social support, and adherence compared to voice delivery.
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
- None
入排标准
- 年龄范围
- 15 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will be 1) provider and patient agreement that medication adherence is currently <80%, 2) access to a cell phone, and 3) ability to speak and understand English.
排除标准
- •Exclusion criteria will include cognitive impairment that precludes participants from engaging in the consent/assent process or study protocol.
结局指标
主要结局
Self-Reported Medication Adherence
时间窗: 12 weeks
percentage of doses taken out of 100%, reported by the adolescent or young adult, assessed using a visual analogue scale
Behavioral Measure of Adherence
时间窗: 18 weeks
percentage of doses taken out of 100%, as measured by the whether participants opened the Medication Event Monitoring System cap the same number of times per day they were prescribed to take medication
次要结局
未报告次要终点
研究者
Caitlin Sayegh
Principal Investigator
Children's Hospital Los Angeles