Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

NCT03651596 | Completed

• 1 other identifier: IRB00167162
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Diseases; Adherence, Medication; Communication

Keywords

Adherence; Adolescence; mHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Beliefs About Medication Scale

  Up to 4 weeks before the study begins and up to 4 weeks after the study ends

• Adolescent Medication Barriers Scale

  Up to 4 weeks before the study begins and up to 4 weeks after the study ends

• Daily Medication Adherence Confidence Scale

  Up to 4 weeks before the study begins and up to 4 weeks after the study ends

• Daily Medication Adherence Importance and Motivation Scale

  Up to 4 weeks before the study begins and up to 4 weeks after the study ends

• Self-reported Adherence

  8 weeks during the study

Study Arms (2)

Standard mHealth Messaging

ACTIVE COMPARATOR

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

mHealth Messaging Intervention

EXPERIMENTAL

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

Behavioral: mHealth Messaging Intervention Group

Interventions

mHealth Messaging Intervention Group BEHAVIORAL

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

mHealth Messaging Intervention

Standard mHealth Messaging Group BEHAVIORAL

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

Standard mHealth Messaging

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Related Publications (2)

• 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.

  PMID: 37306720 DERIVED

• 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.

  PMID: 32795983 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Medication Adherence; Communication

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kristin A Riekert, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 29, 2018
• Study Start: October 1, 2018
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon request.
• Access Criteria: Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database).

Locations

US (1)