Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
Primary Purpose
Chronic Kidney Diseases, Adherence, Medication, Communication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth Messaging Intervention Group
Standard mHealth Messaging Group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Adherence, Adolescence, mHealth
Eligibility Criteria
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).
Sites / Locations
- Johns Hopkins University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard mHealth Messaging
mHealth Messaging Intervention
Arm Description
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.
Individuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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.
Self-reported Adherence
Participants will be surveyed on whether the medication was taken or not (no=0, yes=1).
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).
Full Information
NCT ID
NCT03651596
First Posted
August 24, 2018
Last Updated
April 7, 2020
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03651596
Brief Title
Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
Official Title
Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 14, 2020 (Actual)
Study Completion Date
January 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Adherence, Medication, Communication
Keywords
Adherence, Adolescence, mHealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard mHealth Messaging
Arm Type
Active Comparator
Arm Description
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.
Arm Title
mHealth Messaging Intervention
Arm Type
Experimental
Arm Description
Individuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention.
Intervention Type
Behavioral
Intervention Name(s)
mHealth Messaging Intervention Group
Intervention Description
The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.
Intervention Type
Behavioral
Intervention Name(s)
Standard mHealth Messaging Group
Intervention Description
Standard mHealth messages will be sent to individuals assigned to the active control group during the study.
Primary Outcome Measure Information:
Title
Antihypertensive medication adherence
Description
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
Secondary Outcome Measure Information:
Title
Beliefs About Medication Scale
Description
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
Title
Adolescent Medication Barriers Scale
Description
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
Title
Daily Medication Adherence Confidence Scale
Description
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
Title
Daily Medication Adherence Importance and Motivation Scale
Description
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
Title
Self-reported Adherence
Description
Participants will be surveyed on whether the medication was taken or not (no=0, yes=1).
Time Frame
8 weeks during the study
Title
Impressions of Messages
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin A Riekert, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database) upon request.
IPD Sharing Time Frame
Upon request.
IPD Sharing Access Criteria
Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database).
Citations:
PubMed Identifier
32795983
Citation
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.
Results Reference
derived
Learn more about this trial
Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
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