Adherence, Medication, Chronic Kidney Diseases, Communication
Conditions
Keywords
Adherence, Adolescence, mHealth
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.
Interventions
BEHAVIORALmHealth Messaging Intervention Group
The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.
BEHAVIORALStandard mHealth Messaging Group
Standard mHealth messages will be sent to individuals assigned to the active control group during the study.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
11 Years to 21 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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). |
| 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. |
Countries
United States
Outcome results
None listed