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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04241627
Enrollment
34
Registered
2020-01-27
Start date
2020-08-01
Completion date
2022-08-30
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Adherence

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.

Interventions

BEHAVIORALCell Phone Support

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Children's Hospital Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
15 Years to 21 Years
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Self-Reported Medication Adherence12 weekspercentage of doses taken out of 100%, reported by the adolescent or young adult, assessed using a visual analogue scale
Behavioral Measure of Adherence18 weekspercentage 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Cell Phone Support: 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.
11
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. Cell Phone Support: 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.
12
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. Cell Phone Support: 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.
11
Total34

Baseline characteristics

CharacteristicCell Phone SupportTotalAutomated Text RemindersLive Text Support
Age, Continuous17.82 years
STANDARD_DEVIATION 1.47
17.68 years
STANDARD_DEVIATION 1.39
17.82 years
STANDARD_DEVIATION 1.08
17.42 years
STANDARD_DEVIATION 1.62
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants20 Participants6 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants14 Participants5 Participants4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants10 Participants3 Participants3 Participants
Race (NIH/OMB)
More than one race
1 Participants6 Participants4 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants11 Participants4 Participants4 Participants
Race (NIH/OMB)
White
1 Participants5 Participants0 Participants4 Participants
Region of Enrollment
United States
11 Participants34 Participants11 Participants12 Participants
Sex: Female, Male
Female
5 Participants16 Participants5 Participants6 Participants
Sex: Female, Male
Male
6 Participants18 Participants6 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 120 / 11
other
Total, other adverse events
0 / 110 / 120 / 11
serious
Total, serious adverse events
0 / 110 / 120 / 11

Outcome results

Primary

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

Time frame: 18 weeks

Population: Only participants with who returned their Medication Event Monitoring System cap were analyzed for this outcome.

ArmMeasureValue (MEAN)Dispersion
Cell Phone SupportBehavioral Measure of Adherence40.75 percentage of 100Standard Deviation 47.14
Live Text SupportBehavioral Measure of Adherence11.67 percentage of 100Standard Deviation 12.01
Automated Text RemindersBehavioral Measure of Adherence14.33 percentage of 100Standard Deviation 11.24
Primary

Self-Reported Medication Adherence

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

Time frame: 12 weeks

Population: Only participants with post-treatment self-report data were analyze for this primary outcome.

ArmMeasureValue (MEAN)Dispersion
Cell Phone SupportSelf-Reported Medication Adherence86.55 percentage of 100Standard Deviation 17.58
Live Text SupportSelf-Reported Medication Adherence84.80 percentage of 100Standard Deviation 31.07
Automated Text RemindersSelf-Reported Medication Adherence68.75 percentage of 100Standard Deviation 39.03

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026