Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
- Conditions
- Adherence, MedicationChronic Kidney DiseasesCommunication
- Interventions
- Behavioral: mHealth Messaging Intervention GroupBehavioral: Standard mHealth Messaging Group
- Registration Number
- NCT03651596
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mHealth Messaging Intervention mHealth Messaging Intervention Group Individuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention. Standard mHealth Messaging Standard mHealth Messaging Group 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.
- Primary Outcome Measures
Name Time Method Antihypertensive medication adherence 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.
- Secondary Outcome Measures
Name Time Method Beliefs About Medication Scale Up to 4 weeks before the study begins and up to 4 weeks after the study ends 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).
Daily Medication Adherence Confidence Scale Up to 4 weeks before the study begins and up to 4 weeks after the study ends 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.
Daily Medication Adherence Importance and Motivation Scale Up to 4 weeks before the study begins and up to 4 weeks after the study ends 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.
Self-reported Adherence 8 weeks during the study Participants will be surveyed on whether the medication was taken or not (no=0, yes=1).
Impressions of Messages 8 weeks during the study Participants will be surveyed on their impressions on the helpfulness of messages received (no=0, neither helpful nor unhelpful=1, yes=2).
Adolescent Medication Barriers Scale Up to 4 weeks before the study begins and up to 4 weeks after the study ends 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.
Trial Locations
- Locations (1)
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States