Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

Conditions
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Chronic Kidney Diseases, Adherence, Medication, Communication

Intervention / Treatment
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* Behavioral: mHealth Messaging Intervention Group
* Behavioral: Standard mHealth Messaging Group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard mHealth Messaging<br>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. | Behavioral: Standard mHealth Messaging Group<br>* Standard mHealth messages will be sent to individuals assigned to the active control group during the study.<br>|
| Experimental: mHealth Messaging Intervention<br>Individuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention. | Behavioral: mHealth Messaging Intervention Group<br>* The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antihypertensive medication adherence | 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. | 8 weeks during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beliefs About Medication Scale | 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). | Up to 4 weeks before the study begins and up to 4 weeks after the study ends | 
| Adolescent Medication Barriers Scale | 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. | Up to 4 weeks before the study begins and up to 4 weeks after the study ends | 
| Daily Medication Adherence Confidence Scale | 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. | Up to 4 weeks before the study begins and up to 4 weeks after the study ends | 
| Daily Medication Adherence Importance and Motivation Scale | 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. | Up to 4 weeks before the study begins and up to 4 weeks after the study ends | 
| Self-reported Adherence | Participants will be surveyed on whether the medication was taken or not (no=0, yes=1). | 8 weeks during the study | 
| Impressions of Messages | Participants will be surveyed on their impressions on the helpfulness of messages received (no=0, neither helpful nor unhelpful=1, yes=2). | 8 weeks during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Adolescence, mHealth