Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21224
- Johns Hopkins University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Standard mHealth Messaging
Individuals randomized to the Standard mHealth Messaging Group will receive a standard messaging intervention that has shown some efficacy in improving adherence in other samples.
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Standard mHealth messages will be sent to individuals assigned to the active control group during the study.
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实验性的:mHealth Messaging Intervention
Individuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention.
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The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Antihypertensive medication adherence
大体时间:8 weeks during the study
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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.
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8 weeks during the study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Beliefs About Medication Scale
大体时间:Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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The construct, beliefs about medication, is measured with the Beliefs About Medication Scale.
Mean scores are calculated for the the Positive Outcome Expectancies subscale (scale range = 1 to 7, higher scores indicate more positive beliefs) and the Negative Outcome Expectancies subscale (scale range = 1 to 7, higher scores indicate more negative beliefs).
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Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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Adolescent Medication Barriers Scale
大体时间:Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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The construct, barriers to adherence, is measured with the Adolescent Medication Barriers Scale (AMBS).
The AMBS is reported as an overall mean score ranging from 1 to 5 with higher scores indicating more barriers to adherence.
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Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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Daily Medication Adherence Confidence Scale
大体时间:Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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The construct, medication adherence confidence, is measured with the Daily Medication Adherence Confidence Scale.
This scale is reported as an overall mean score ranging from 1 to 10 with higher scores indicating more medication adherence confidence.
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Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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Daily Medication Adherence Importance and Motivation Scale
大体时间:Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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The construct, medication adherence importance and motivation, is measured with the Daily Medication Adherence Importance and Motivation Scale.
The scale is reported as an overall mean score ranging from 1 to 10 with higher scores indicating higher daily medication adherence importance and motivation.
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Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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Self-reported Adherence
大体时间:8 weeks during the study
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Participants will be surveyed on whether the medication was taken or not (no=0, yes=1).
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8 weeks during the study
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Impressions of Messages
大体时间:8 weeks during the study
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Participants will be surveyed on their impressions on the helpfulness of messages received (no=0, neither helpful nor unhelpful=1, yes=2).
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8 weeks during the study
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合作者和调查者
调查人员
- 首席研究员:Kristin A Riekert, PhD、Johns Hopkins University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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