An interventional study of mHealth Messaging Intervention Group and Standard mHealth Messaging Group in Chronic Kidney Diseases, Adherence, Medication and Communication, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 11 Years to 21 Years. Per ClinicalTrials.gov, last updated 2020-04-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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).
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 35 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
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
Individuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention.
Behavioral: mHealth Messaging Intervention Group
The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.
Standard mHealth messages will be sent to individuals assigned to the active control group during the study.
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.
Time frame: 8 weeks during the study
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 8 weeks during the study
Plan to share: Yes — Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database) upon request.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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