Medication AdherenceACPSNCT05719064
Early Prototyping and Usability Testing (ACPS)
A study testing Adaptive Cell Phone Support 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 refine and 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- has a cell phone
- There is no exclusion criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
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 refine and test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. The main question[s] it aims to answer are:
- How should the intervention be designed to best fit patients' needs and preferences?
- 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
An initial cohort of adolescents with chronic health conditions will be asked to try the intervention and give feedback to refine the structure and content. Then, a larger cohort will progress through a sequential multiple assignment randomized trial to 1) be randomized to either automated text reminders (active control condition) or computer-delivered Cell Phone Support and then 2) those in the computer-delivered Cell Phone Support condition who do not show a sufficient response will be re-assigned to continued computer-delivered Cell Phone Support only or to Adaptive Cell Phone Support ( computer-delivered Cell Phone Support + responsive human coaching).
- Conditions
- Medication Adherence
- Being tested
- Adaptive Cell Phone Support
- 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
| 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 improved medication adherence. Receives: Behavioral: Adaptive Cell Phone Support |
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. This is the value reported at the end of the three week study.
Measured: 3 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. These are the results collected at 3 weeks.
Measured: 3 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. These are the results collected at 3 weeks.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start26 Jan 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
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
- NCT05719064
- Sponsor's protocol ID
- CHLA-23-00149_Phase I
- Acronym
- ACPS
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2023
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data and associated documentation will be made available to the research community free of charge through the data repository hosted at Open Science Framework (OSF).
Publications
Sayegh CS, Wu S, Lopez S, Dews A, Fleming J, Cortez D, Portillo J, Menendez T, Belzer M, West AE. Feasibility, Usability, and Acceptability of an Adaptive Mobile Health Medication Adherence Intervention for Youth: Iterative Mixed Methods Human-Centered Design Study. JMIR Form Res. 2026 Aug 5;10:e87124. doi: 10.2196/87124.
PubMed 42555969
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. 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
- NCT05719064
- Acronym / sponsor ID
- ACPS / CHLA-23-00149_Phase I
- Conditions
- Medication Adherence
- Keywords
- Adolescents, Mobile health, chronic illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Posted 13 Oct 2026
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 refine and test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. The main question[s] it aims to answer are:
- How should the intervention be designed to best fit patients' needs and preferences?
- 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
An initial cohort of adolescents with chronic health conditions will be asked to try the intervention and give feedback to refine the structure and content. Then, a larger cohort will progress through a sequential multiple assignment randomized trial to 1) be randomized to either automated text reminders (active control condition) or computer-delivered Cell Phone Support and then 2) those in the computer-delivered Cell Phone Support condition who do not show a sufficient response will be re-assigned to continued computer-delivered Cell Phone Support only or to Adaptive Cell Phone Support ( computer-delivered Cell Phone Support + responsive human coaching).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Cell Phone Support | Experimental | Behavioral: Adaptive 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 improved medication adherence. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 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 |
Primary outcome
Mean Scores on the Mobile Health App Usability Questionnaire
Time frame: 3 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. This is the value reported at the end of the three week study.
Total Scores on the Theoretical Framework of Acceptability Questionnaire
Time frame: 3 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. These are the results collected at 3 weeks.
Total Scores on the Visual Analogue Scale
Time frame: 3 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. These are the results collected at 3 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42555969Sayegh CS, Wu S, Lopez S, Dews A, Fleming J, Cortez D, Portillo J, Menendez T, Belzer M, West AE. Feasibility, Usability, and Acceptability of an Adaptive Mobile Health Medication Adherence Intervention for Youth: Iterative Mixed Methods Human-Centered Design Study. JMIR Form Res. 2026 Aug 5;10:e87124. doi: 10.2196/87124.
- Individual participant dataSharing planned: Yes. De-identified study data and associated documentation will be made available to the research community free of charge through the data repository hosted at Open Science Framework (OSF).
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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. This study is not recruiting at the moment.
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 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 7 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: finished, as of the sponsor's last update on 13 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 13 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719064, which also lists 1 linked publication.
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 13 Oct 2026.