Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

Chronic Kidney Diseases Clinical Trial

Official title:

Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651596
• Other study ID #: IRB00167162
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 14, 2020

Study information

• Verified date: April 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 21 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adherence, Medication
• Chronic Kidney Diseases
• Communication
• Kidney Diseases
• Renal Insufficiency, Chronic

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 Messaging Group
Standard mHealth messages will be sent to individuals assigned to the active control group during the study.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-reported Adherence	Participants will be surveyed on whether the medication was taken or not (no=0, yes=1).	8 weeks during the study
Secondary	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