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Completed

NCT Number: NCT03651596

Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

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).

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Key information

Conditions

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

Age range

11 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

mHealth Messaging Intervention Group

Behavioral

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

Standard mHealth Messaging Group

Behavioral

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

Primary outcomes

  1. Antihypertensive medication adherence

    Time frame: 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 outcomes

  1. Beliefs About Medication Scale

    Time frame: 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).

  2. Adolescent Medication Barriers Scale

    Time frame: 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.

  3. Daily Medication Adherence Confidence Scale

    Time frame: 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.

  4. Daily Medication Adherence Importance and Motivation Scale

    Time frame: 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.

  5. Self-reported Adherence

    Time frame: 8 weeks during the study

    Participants will be surveyed on whether the medication was taken or not (no=0, yes=1).

  6. Impressions of Messages

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2018
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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