- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04241627
Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
Mobile Health Intervention to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
Background: Adolescents and young adults (AYAs) with chronic illnesses often struggle to develop illness self-management skills. Mobile health (mHealth) interventions have been developed for some specific chronic illnesses, but flexible interventions that can be generalized across conditions are needed to accelerate translation.
Research Hypotheses: 1) Cell phone support (CPS) will increase medication adherence and self-management skills across a variety of health conditions; 2) CPS delivered by text message will outperform CPS delivered by phone calls; 3) Patients' perceptions of the human adherence facilitator (AF) will differ based on the mode of communication, text message versus phone calls.
Design: A randomized, controlled, 3-arm pilot trial, following community-based participatory research (CBPR) principles, will test the impact of AF delivered by phone calls or text messages on medication adherence and illness self-management. Conditions will be CPS delivered by phone calls, CPS delivered by text messages, or usual care.
Participants: Participants will include AYAs with diverse chronic illnesses aged 15-20 years (N = 60).
Methods: This study will involve piloting CPS via different communication modes in a randomized trial, informed by CBPR principles. Questionnaires and focus groups will be used to understand how patients perceive the intervention and adherence facilitator.
Main Outcome Measures: Outcomes will include medication and appointment adherence, pharmacy refill ratios, self-management skills, and perceptions of the AF.
Innovation: This study will provide new knowledge regarding how to promote illness self-management skills, and may result in an mHealth intervention with the potential to widely impact supportive care for AYAs with chronic illnesses.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caitlin S Sayegh, PhD
- Phone Number: 323-361-7748
- Email: cssayegh@chla.usc.edu
Study Locations
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inclusion criteria will be 1) provider and patient agreement that medication adherence is currently <80%, 2) access to a cell phone, and 3) ability to speak and understand English.
Exclusion Criteria:
- Exclusion criteria will include cognitive impairment that precludes participants from engaging in the consent/assent process or study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cell Phone Support
An adherence facilitator will deliver Cell Phone Support by daily phone calls Monday through Friday for 12 weeks, to provide social support, medication reminders, problem-solving coaching, incentives for answering calls, and referrals to other services.
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Cell Phone Support includes short phone calls (<5 minutes) made each weekday by a human AF to provide social support, medication reminders, problem-solving coaching, incentives for answering calls, and referrals to other services.
Cell Phone Support calls focus on assisting AYAs in identifying and accessing resources and support from their natural environments, such as finding ways they can receive needed help from their families, peers, medical teams, and communities.
Live Text Support will deliver the same intervention, by text message.
Other Names:
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Experimental: Live Text Support
An adherence facilitator will deliver Live Text Support, Monday through Friday for 12 weeks, to provide social support, medication reminders, problem-solving coaching, incentives for answering calls, and referrals to other services.
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Cell Phone Support includes short phone calls (<5 minutes) made each weekday by a human AF to provide social support, medication reminders, problem-solving coaching, incentives for answering calls, and referrals to other services.
Cell Phone Support calls focus on assisting AYAs in identifying and accessing resources and support from their natural environments, such as finding ways they can receive needed help from their families, peers, medical teams, and communities.
Live Text Support will deliver the same intervention, by text message.
Other Names:
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Active Comparator: Automated Text Reminders
The comparison condition will include automated text message reminders, using this template: "Take [name of medication] at [set time].
To confirm intake, press REPLY, type CARE 1, and press SEND."
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Cell Phone Support includes short phone calls (<5 minutes) made each weekday by a human AF to provide social support, medication reminders, problem-solving coaching, incentives for answering calls, and referrals to other services.
Cell Phone Support calls focus on assisting AYAs in identifying and accessing resources and support from their natural environments, such as finding ways they can receive needed help from their families, peers, medical teams, and communities.
Live Text Support will deliver the same intervention, by text message.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Reported Medication Adherence
Time Frame: 12 weeks
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percentage of doses taken out of 100%, reported by the adolescent or young adult, assessed using a visual analogue scale
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12 weeks
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Behavioral Measure of Adherence
Time Frame: 18 weeks
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percentage of doses taken out of 100%, as measured by the whether participants opened the Medication Event Monitoring System cap the same number of times per day they were prescribed to take medication
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18 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Caitlin Sayegh, PhD, Children's Hospital Los Angeles
Publications and helpful links
General Publications
- Belzer ME, Naar-King S, Olson J, Sarr M, Thornton S, Kahana SY, Gaur AH, Clark LF; Adolescent Medicine Trials Network for HIV/AIDS Interventions. The use of cell phone support for non-adherent HIV-infected youth and young adults: an initial randomized and controlled intervention trial. AIDS Behav. 2014 Apr;18(4):686-96. doi: 10.1007/s10461-013-0661-3.
- Sayegh CS, Szmuszkovicz JR, Menteer J, Sherer S, Thomas D, Lestz R, Belzer M. Cell phone support to improve medication adherence among solid organ transplant recipients. Pediatr Transplant. 2018 Jun 19:e13235. doi: 10.1111/petr.13235. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHLA-20-00168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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