N/A
N=34
Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
Medication Adherence
Bottom Line
View on ClinicalTrials.gov: NCT04241627 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Self-Reported Medication Adherence — 86.55; 84.80; 68.75 percentage of 100
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cell Phone Support (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Los Angeles
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Reported Medication Adherence |
86.55; 84.80; 68.75 | — |
| PRIMARY Behavioral Measure of Adherence |
40.75; 11.67; 14.33 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04241627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.