Trial Outcomes & Findings for Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness (NCT NCT04241627)
NCT ID: NCT04241627
Last Updated: 2024-01-08
Results Overview
percentage of doses taken out of 100%, reported by the adolescent or young adult, assessed using a visual analogue scale
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-01-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
11
|
|
Overall Study
COMPLETED
|
11
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
Baseline characteristics by cohort
| Measure |
Cell Phone Support
n=11 Participants
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.
|
Live Text Support
n=12 Participants
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.
|
Automated Text Reminders
n=11 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
17.82 years
STANDARD_DEVIATION 1.47 • n=5 Participants
|
17.42 years
STANDARD_DEVIATION 1.62 • n=7 Participants
|
17.82 years
STANDARD_DEVIATION 1.08 • n=5 Participants
|
17.68 years
STANDARD_DEVIATION 1.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Only participants with post-treatment self-report data were analyze for this primary outcome.
percentage of doses taken out of 100%, reported by the adolescent or young adult, assessed using a visual analogue scale
Outcome measures
| Measure |
Cell Phone Support
n=11 Participants
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.
|
Live Text Support
n=10 Participants
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.
|
Automated Text Reminders
n=8 Participants
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.
|
|---|---|---|---|
|
Self-Reported Medication Adherence
|
86.55 percentage of 100
Standard Deviation 17.58
|
84.80 percentage of 100
Standard Deviation 31.07
|
68.75 percentage of 100
Standard Deviation 39.03
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Only participants with who returned their Medication Event Monitoring System cap were analyzed for this outcome.
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
Outcome measures
| Measure |
Cell Phone Support
n=4 Participants
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.
|
Live Text Support
n=3 Participants
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.
|
Automated Text Reminders
n=3 Participants
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.
|
|---|---|---|---|
|
Behavioral Measure of Adherence
|
40.75 percentage of 100
Standard Deviation 47.14
|
11.67 percentage of 100
Standard Deviation 12.01
|
14.33 percentage of 100
Standard Deviation 11.24
|
Adverse Events
Cell Phone Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Live Text Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Automated Text Reminders
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Caitlin Sayegh
University of Southern California Keck School of Medicine Department of Pediatrics
Phone: 13233617748
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place