Medication AdherenceACPSNCT07084155
Final Prototype Refinement of Adaptive Cell Phone Support
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 feasibility pilot trial is to finalize the design of 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: 1. 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to 31 Jan 2027
- 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 at enrollment
- 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, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Caitlin S Sayegh, PhD, 323-361-7748, cssayegh@chla.usc.edu
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 feasibility pilot trial is to finalize the design of 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:
- Is the final version of the intervention sufficiently feasible, usable, and acceptable for evaluation in a randomized clinical trial?
- Do participants show improvements in medication adherence during their field testing of the intervention?
Read the detailed description
Adolescents with chronic health conditions will be asked to try the intervention for three weeks and give feedback to refine the structure and content in preparation for a future randomized trial of the finalized version of the intervention. Plan to enroll 35 participants in this single arm feasibility/usability trial.
- Conditions
- Medication Adherence
- Being tested
- Adaptive Cell Phone Support
- Keywords
- adolescents, mobile health, adherence
- Medical subject headings
- Medication Adherence
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 improve 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.
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 3 weeks
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 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.
Measured: Baseline to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start25 Mar 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 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
- NCT07084155
- Sponsor's protocol ID
- CHLA-23-00149_Phase II
- Other IDs
- 1K23HD119369
- Acronym
- ACPS
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2025
- Last updated
- 20 Jul 2026
- 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 20 Jul 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
- NCT07084155
- Acronym / sponsor ID
- ACPS / CHLA-23-00149_Phase II
- Conditions
- Medication Adherence
- Keywords
- adolescents, mobile health, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 24 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 feasibility pilot trial is to finalize the design of 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:
- Is the final version of the intervention sufficiently feasible, usable, and acceptable for evaluation in a randomized clinical trial?
- Do participants show improvements in medication adherence during their field testing of the intervention?
Detailed description
Adolescents with chronic health conditions will be asked to try the intervention for three weeks and give feedback to refine the structure and content in preparation for a future randomized trial of the finalized version of the intervention. Plan to enroll 35 participants in this single arm feasibility/usability trial.
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 improve medication adherence. |
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 at enrollment
- 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
Total scores on the theoretical framework of acceptability questionnaire
Time frame: Baseline to 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.
Mean scores on the Mobile Health App Usability Questionnaire
Time frame: Baseline to 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.
Total scores on the Visual Analogue Scale
Time frame: Baseline to 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.
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 20 Jul 2026.
- 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 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: looking for participants now, as of the sponsor's last update on 20 Jul 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?
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 (323-361-7748, cssayegh@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total scores on the theoretical framework of acceptability questionnaire (time frame: Baseline to 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?
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 20 Jul 2026.