Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness

NCT04241627 | Completed Results

• 1 other identifier: CHLA-20-00168
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (2)

• Self-Reported Medication Adherence

  percentage of doses taken out of 100%, reported by the adolescent or young adult, assessed using a visual analogue scale

  12 weeks

• Behavioral Measure of Adherence

  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

  18 weeks

Study Arms (3)

Cell Phone Support

EXPERIMENTAL

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.

Behavioral: Cell Phone Support

Live Text Support

EXPERIMENTAL

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.

Behavioral: Cell Phone Support

Automated Text Reminders

ACTIVE COMPARATOR

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."

Behavioral: Cell Phone Support

Interventions

Cell Phone Support BEHAVIORAL

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.

Also known as: Live Text Support

Automated Text Reminders; Cell Phone Support; Live Text Support

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (3)

• 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.

  PMID: 24271347 RESULT

• 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.

  PMID: 29920879 RESULT

• Sayegh CS, MacDonell KK, Iverson E, Beard B, Chang N, Vu MH, Belzer M. Randomized pilot trial of cell phone support to improve medication adherence among adolescents and young adults with chronic health conditions. BMC Digit Health. 2024;2(1):13. doi: 10.1186/s44247-024-00069-w. Epub 2024 Mar 19.

  PMID: 39211575 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Caitlin Sayegh
• Organization: University of Southern California Keck School of Medicine Department of Pediatrics

cssayegh@chla.usc.edu

13233617748

Study Officials

• Caitlin Sayegh, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We will randomly assign participants to cell phone support by voice, cell phone support by text message, or automated text reminders.

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: August 1, 2020
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: January 8, 2024
• Results First Posted: June 15, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)