Chronic Kidney DiseasesNCT03651596
Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
A study testing mHealth Messaging Intervention Group and Standard mHealth Messaging Group in people with Chronic Kidney Diseases and Adherence, Medication, run by Johns Hopkins University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Chronic Kidney Diseases, Adherence, Medication, Communication
- What is being tested?
- mHealth Messaging Intervention Group and Standard mHealth Messaging Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 14 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
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).
Read the 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.
- Being tested
- mHealth Messaging Intervention Group, Standard mHealth Messaging Group
- Keywords
- Adherence, Adolescence, mHealth
- Medical subject headings
- Renal Insufficiency, Chronic, Medication Adherence, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Messaging Intervention GroupBehavioural
The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.
Standard mHealth Messaging GroupBehavioural
Standard mHealth messages will be sent to individuals assigned to the active control group during the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Standard mHealth Messaging Group |
| mHealth Messaging Intervention | Experimental | Individuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention. Receives: Behavioral: mHealth Messaging Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks during the study
Secondary outcomes (6)
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).
Measured: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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.
Measured: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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.
Measured: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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.
Measured: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
Self-reported Adherence
Participants will be surveyed on whether the medication was taken or not (no=0, yes=1).
Measured: 8 weeks during the study
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).
Measured: 8 weeks during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Oct 2018
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin A Riekert, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651596
- Sponsor's protocol ID
- IRB00167162
- Status last verified
- Apr 2020
- First submitted
- 24 Aug 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database) upon request.
Publications
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.
PubMed 37306720Eaton 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.
PubMed 32795983
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
- ClinicalTrials.gov ID
- NCT03651596
- Acronym / sponsor ID
- IRB00167162
- Keywords
- Adherence, Adolescence, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard mHealth Messaging | Active comparator | Behavioral: Standard mHealth Messaging GroupIndividuals randomized to the Standard mHealth Messaging Group will receive a standard messaging intervention that has shown some efficacy in improving adherence in other samples. |
| mHealth Messaging Intervention | Experimental | Behavioral: mHealth Messaging Intervention GroupIndividuals randomized to the mHealth Messaging Intervention Group will receive the newly developed messaging intervention. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Messaging Intervention GroupThe newly developed intervention messages will be sent to individuals assigned to the intervention group during the study. | Behavioural | mHealth Messaging Intervention |
| Standard mHealth Messaging GroupStandard mHealth messages will be sent to individuals assigned to the active control group during the study. | Behavioural | Standard mHealth Messaging |
Primary outcome
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.
6 secondary outcomes
Beliefs About Medication Scale
Time frame: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
Adolescent Medication Barriers Scale
Time frame: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
Daily Medication Adherence Confidence Scale
Time frame: Up to 4 weeks before the study begins and up to 4 weeks after the study ends
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
Self-reported Adherence
Time frame: 8 weeks during the study
Impressions of Messages
Time frame: 8 weeks during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 37306720Eaton 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.
- Derived from this study: PubMed 32795983Eaton 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.
- Individual participant dataSharing planned: Yes. Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database) upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin A Riekert, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Messaging Intervention Group and Standard mHealth Messaging Group in people with Chronic Kidney Diseases and Adherence, Medication, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antihypertensive medication adherence (time frame: 8 weeks during the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03651596, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.