Clinical trial NCT03651596: Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
Official title: Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Adherence, Medication
Communication
Keywords: Adherence
Adolescence
mHealth
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 35
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Antihypertensive medication adherence
timeFrame: 8 weeks during the study
Secondary outcomes:
measure: Beliefs About Medication Scale
timeFrame: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
measure: Adolescent Medication Barriers Scale
timeFrame: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
measure: Daily Medication Adherence Confidence Scale
timeFrame: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
measure: Daily Medication Adherence Importance and Motivation Scale
timeFrame: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
measure: Self-reported Adherence
timeFrame: 8 weeks during the study
measure: Impressions of Messages
timeFrame: 8 weeks during the study
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kristin A Riekert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eaton C, Comer M, Pruette C, Psoter K, Riekert K. Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews. J Med Internet Res. 2020 Aug 14;22(8):e19861. doi: 10.2196/19861.