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临床试验/NCT03651596
NCT03651596已完成不适用

Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Antihypertensive medication adherence

研究概览

简要总结

The overall goal of this study is to develop and test effectively framed mobile health (mHealth) messages to promote medication adherence in teens with chronic kidney disease (CKD).

详细描述

Hypertension is a risk factor for chronic kidney disease (CKD) progression. Only 77% of adolescents with CKD are adherent to antihypertensive medications despite evidence that adherence slows disease progression. Mobile health (mHealth) applications show promise for improving adherence but most are not designed within health-promotion frameworks, only send medication reminders, use unreliable outcome measures, and/or have small effects on adherence. Nonadherence is a public health problem that may benefit from using health communication strategies to advance beyond reminders and improve mHealth efficacy. Highly effective health messages modify perceptions, attitudes, and skills to facilitate behavioral change; inappropriately framed messages (e.g., use of fear appeals) may have unintended, negative effects on health behaviors (i.e., reduce adherence). For adolescents with CKD, framing mHealth messages to motivate adherence may be a key factor in preventing disease progression; however, there has been little research to guide the use of this approach. Hence, the current study aims to develop and test effectively framed mobile health (mHealth) messages to promote medication adherence in teens with CKD.

Prior to study recruitment, the intervention messages will be developed by the research team and key stakeholders before testing in this pilot randomized controlled trial (RCT). Adolescents/young adults with CKD will be invited to participate in the pilot RCT to evaluate the intervention messages versus an active control condition; the primary outcome is antihypertensive medication adherence and secondary outcomes are participants' responses to surveys.

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
11 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents/young adults aged 11-21 years
  • Physician diagnosis of CKD stage 1-4
  • Currently prescribed an antihypertensive medication and anticipate staying on an antihypertensive through the study duration (switching medication classes is permitted)
  • Must have daily access to a Wi-Fi-enabled electronic device (e.g. iOS, Android 4.2 or higher, phone, tablet, computer) to receive private health information.

排除标准

  • Adolescents/young adults who are on dialysis or had a kidney transplant
  • Sibling participating in the study, unable to comprehend spoken English
  • Cognitive delay precluding completion of study procedures
  • And prescribed a liquid form of an antihypertensive medication (cannot be monitored).

结局指标

主要结局

Antihypertensive medication adherence

时间窗: 8 weeks during the study

Electronic medication monitoring will be used to assess medication adherence, defined as the percentage of doses taken; higher percentages reflect that more doses were taken.

次要结局

  • Beliefs About Medication Scale(Up to 4 weeks before the study begins and up to 4 weeks after the study ends)
  • Daily Medication Adherence Confidence Scale(Up to 4 weeks before the study begins and up to 4 weeks after the study ends)
  • Daily Medication Adherence Importance and Motivation Scale(Up to 4 weeks before the study begins and up to 4 weeks after the study ends)
  • Self-reported Adherence(8 weeks during the study)
  • Impressions of Messages(8 weeks during the study)
  • Adolescent Medication Barriers Scale(Up to 4 weeks before the study begins and up to 4 weeks after the study ends)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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