Medication AdherenceACPSNCT07064824
Adaptive Cell Phone Support (ACPS)
A study testing Adaptive Cell Phone Support, Computer-Delivered Cell Phone Support and Automated Text Reminders in people with Medication Adherence, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Adaptive Cell Phone Support, Computer-Delivered Cell Phone Support and Automated Text Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2027to 30 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children's Hospital Los Angeles patient
- between 15-20 years old
- taking at least one oral medication per day for a chronic health condition
- English speaking
- demonstrating sufficient cognitive capacity to engage in the assent/consent process and study procedures
- There is no exclusion criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children Hospital Los Angeles
Los Angeles, California, 90027
Caitlin Sayegh, PhD, 13233617748, cssayegh@chla.usc.edu
Caitlin Sayegh, PhD
About this study
Official title: Adaptive Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Health Conditions
The goal of this pilot clinical trial is to test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. The main question it aims to answer is:
-Is an adaptive intervention (personalizing the intensity of support based on patients' needs) efficacious for promoting medication adherence Researchers will compare the adaptive intervention to automated text message reminders see if the adaptive intervention shows stronger positive effects on medication adherence.
Read the detailed description
Plan to enroll 96 participants in this study, which is a sequential randomized trial.
- Conditions
- Medication Adherence
- Being tested
- Adaptive Cell Phone Support, Computer-Delivered Cell Phone Support, Automated Text Reminders
- Keywords
- Adolescents, Mobile health, chronic illness
- Medical subject headings
- Medication Adherence, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Cell Phone SupportBehavioural
Mobile health adherence promotion based on the supportive accountability model
Computer-Delivered Cell Phone SupportBehavioural
Mobile health adherence promotion based on the supportive accountability model
Automated Text RemindersBehavioural
Scheduled text reminder to take medication
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Cell Phone Support | Experimental | Computer-delivered cell phone support (reminders, problem-solving, referrals to resources) and responsive human coaching (phone calls, test messages, in-app messaging) to improve medication adherence. Receives: Behavioral: Adaptive Cell Phone Support; Behavioral: Computer-Delivered Cell Phone Support |
| Computer-Delivered Cell Phone Support | Experimental | Computer-delivered cell phone support (reminders, problem-solving, referrals to resources) Receives: Behavioral: Computer-Delivered Cell Phone Support |
| Automated Text Reminders | Active comparator | Scheduled one-way text automated message reminders to take medication Receives: Behavioral: Automated Text Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean scores on the Mobile Health App Usability Questionnaire
Higher scores indicate greater ease with which users can use technology to achieve a particular goal; the minimum value of this questionnaire is 1 and the maximum value is 7.
Measured: Baseline to 12 weeks
Total scores on the theoretical framework of acceptability questionnaire
Higher scores indicate a greater "extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention"; the minimum value of this questionnaire is 7 and the maximum value is 35.
Measured: Baseline to 12 weeks
Total scores on the Visual Analogue Scale
Percentage of doses taken our of 100%; higher numbers indicate greater medication adherence. This scale presents participants with a line, marked 0 on the left and 100 on the right, and participants can drag a marker to the place on the line that best visually indicated their adherence.
Measured: Baseline to 12 weeks
Total scores on Rollnick's Readiness Ruler
Higher scores on this measure indicate more motivation to take medication as prescribed; the minimum value of this questionnaire is 0 and the maximum value is 10.
Measured: Baseline to 12 weeks
Total Transition Readiness scores on the Successful Transition to Adulthood with Therapeutic = Rx Questionnaire
Higher scores on extent to which patients are prepared to manage their health condition as adults, outside of the pediatric system; ; the minimum value of this questionnaire is 0 and the maximum value is 90.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Aug 2027 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin Sayegh, Children's Hospital Los Angeles
- Investigators
- Caitlin Sayegh, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064824
- Sponsor's protocol ID
- CHLA-23-00149_Phase III
- Acronym
- ACPS
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will include electronically-administered survey items assessing demographic characteristics, intervention usability, intervention acceptability, medication adherence, motivation for adherence, transition readiness skills, and allocation of treatment responsibility as well as medication regimen complexity data and pharmacy possession refill rates abstracted from the electronic medical chart, and behavioral engagement data collected via the Computerized Intervention Authoring Software.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Health Conditions
- ClinicalTrials.gov ID
- NCT07064824
- Acronym / sponsor ID
- ACPS / CHLA-23-00149_Phase III
- Conditions
- Medication Adherence
- Keywords
- Adolescents, Mobile health, chronic illness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot clinical trial is to test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. The main question it aims to answer is:
-Is an adaptive intervention (personalizing the intensity of support based on patients' needs) efficacious for promoting medication adherence Researchers will compare the adaptive intervention to automated text message reminders see if the adaptive intervention shows stronger positive effects on medication adherence.
Detailed description
Plan to enroll 96 participants in this study, which is a sequential randomized trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adaptive Cell Phone Support | Experimental | Behavioral: Adaptive Cell Phone Support, Behavioral: Computer-Delivered Cell Phone SupportComputer-delivered cell phone support (reminders, problem-solving, referrals to resources) and responsive human coaching (phone calls, test messages, in-app messaging) to improve medication adherence. |
| Computer-Delivered Cell Phone Support | Experimental | Behavioral: Computer-Delivered Cell Phone SupportComputer-delivered cell phone support (reminders, problem-solving, referrals to resources) |
| Automated Text Reminders | Active comparator | Behavioral: Automated Text RemindersScheduled one-way text automated message reminders to take medication |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children's Hospital Los Angeles patient
- between 15-20 years old
- taking at least one oral medication per day for a chronic health condition
- English speaking
- demonstrating sufficient cognitive capacity to engage in the assent/consent process and study procedures
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Cell Phone SupportMobile health adherence promotion based on the supportive accountability model | Behavioural | Adaptive Cell Phone Support |
| Computer-Delivered Cell Phone SupportMobile health adherence promotion based on the supportive accountability model | Behavioural | Adaptive Cell Phone Support, Computer-Delivered Cell Phone Support |
| Automated Text RemindersScheduled text reminder to take medication | Behavioural | Automated Text Reminders |
Primary outcome
Mean scores on the Mobile Health App Usability Questionnaire
Time frame: Baseline to 12 weeks
Higher scores indicate greater ease with which users can use technology to achieve a particular goal; the minimum value of this questionnaire is 1 and the maximum value is 7.
Total scores on the theoretical framework of acceptability questionnaire
Time frame: Baseline to 12 weeks
Higher scores indicate a greater "extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention"; the minimum value of this questionnaire is 7 and the maximum value is 35.
Total scores on the Visual Analogue Scale
Time frame: Baseline to 12 weeks
Percentage of doses taken our of 100%; higher numbers indicate greater medication adherence. This scale presents participants with a line, marked 0 on the left and 100 on the right, and participants can drag a marker to the place on the line that best visually indicated their adherence.
Total scores on Rollnick's Readiness Ruler
Time frame: Baseline to 12 weeks
Higher scores on this measure indicate more motivation to take medication as prescribed; the minimum value of this questionnaire is 0 and the maximum value is 10.
Total Transition Readiness scores on the Successful Transition to Adulthood with Therapeutic = Rx Questionnaire
Time frame: Baseline to 12 weeks
Higher scores on extent to which patients are prepared to manage their health condition as adults, outside of the pediatric system; ; the minimum value of this questionnaire is 0 and the maximum value is 90.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will include electronically-administered survey items assessing demographic characteristics, intervention usability, intervention acceptability, medication adherence, motivation for adherence, transition readiness skills, and allocation of treatment responsibility as well as medication regimen complexity data and pharmacy possession refill rates abstracted from the electronic medical chart, and behavioral engagement data collected via the Computerized Intervention Authoring Software.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin Sayegh, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Cell Phone Support, Computer-Delivered Cell Phone Support and Automated Text Reminders in people with Medication Adherence, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitlin Sayegh, PhD (13233617748, cssayegh@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean scores on the Mobile Health App Usability Questionnaire (time frame: Baseline to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025; AzTrials last refreshed its copy on 29 Oct 2026.