Clinical trial NCT04241627: Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
Official title: Mobile Health Intervention to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-01-27
Enrollment: 34
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will randomly assign participants to cell phone support by voice, cell phone support by text message, or automated text reminders.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The aim of this randomized pilot trial is to evaluate the acceptability, feasibility, and efficacy of CPS delivered by phone calls or text messages to AYAs with two distinct chronic illnesses, in preparation for an R01 proposal to conduct a multisite, effectiveness-implementation hybrid trial. We propose 1) assessing the feasibility, acceptability, and efficacy of CPS for improving medication adherence, 2) investigating the impact of delivering CPS through live text messages versus phone calls using quantitative and qualitative methods, and 3) evaluating patient and provider views of CPS to guide future implementation work. The proposed research follows the conceptual model, illustrated below, positing that CPS will promote adherence through engaging AYAs in calls or texts with a human AF providing social support. We predict that delivering CPS by text message will increase feasibility and acceptability, perceived social support, and adherence compared to voice delivery.

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.

Primary outcomes:
measure: Self-Reported Medication Adherence
timeFrame: 12 weeks
measure: Behavioral Measure of Adherence
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Caitlin Sayegh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.