Medication Adherence
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Medication Adherence | 12 weeks | percentage of doses taken out of 100%, reported by the adolescent or young adult, assessed using a visual analogue scale |
| Behavioral Measure of Adherence | 18 weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 34 |
Baseline characteristics
| Characteristic | Cell Phone Support | Total | Automated Text Reminders | Live Text Support |
|---|---|---|---|---|
| Age, Continuous | 17.82 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 Participants | 20 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 14 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 10 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 6 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 11 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 0 Participants | 4 Participants |
| Region of Enrollment United States | 11 Participants | 34 Participants | 11 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 18 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 | 0 / 11 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cell Phone Support | Behavioral Measure of Adherence | 40.75 percentage of 100 | Standard Deviation 47.14 |
| Live Text Support | Behavioral Measure of Adherence | 11.67 percentage of 100 | Standard Deviation 12.01 |
| Automated Text Reminders | Behavioral Measure of Adherence | 14.33 percentage of 100 | Standard Deviation 11.24 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cell Phone Support | Self-Reported Medication Adherence | 86.55 percentage of 100 | Standard Deviation 17.58 |
| Live Text Support | Self-Reported Medication Adherence | 84.80 percentage of 100 | Standard Deviation 31.07 |
| Automated Text Reminders | Self-Reported Medication Adherence | 68.75 percentage of 100 | Standard Deviation 39.03 |