Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

NCT ID: NCT03651596

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-01-14

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases Adherence, Medication Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard mHealth Messaging

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.

Group Type ACTIVE_COMPARATOR

Standard mHealth Messaging Group

Intervention Type BEHAVIORAL

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

mHealth Messaging Intervention

Individuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention.

Group Type EXPERIMENTAL

mHealth Messaging Intervention Group

Intervention Type BEHAVIORAL

The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.

Interventions

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mHealth Messaging Intervention Group

The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.

Intervention Type BEHAVIORAL

Standard mHealth Messaging Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

11 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin A Riekert, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Eaton CK, Comer M, Pruette CS, Riekert KA. Medication adherence in youths with CKD: habits for success. Pediatr Nephrol. 2023 Nov;38(11):3791-3802. doi: 10.1007/s00467-023-05976-0. Epub 2023 Jun 12.

Reference Type DERIVED
PMID: 37306720 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32795983 (View on PubMed)

Other Identifiers

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IRB00167162

Identifier Type: -

Identifier Source: org_study_id

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