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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cell Phone Support

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Cell Phone Support

Intervention Type 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.

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."

Group Type ACTIVE_COMPARATOR

Cell Phone Support

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Live Text Support

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No