Medication AdherenceNCT04241627
Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
A study testing Cell Phone Support in people with Medication Adherence, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Cell Phone Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 30 Aug 2022
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria will include cognitive impairment that precludes participants from engaging in the consent/assent process or study protocol.
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: Mobile Health Intervention to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
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.
Read more
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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Cell Phone Support
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell Phone SupportBehavioural
Also called Live Text 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.
| Study group | Role | What they receive |
|---|---|---|
| Cell Phone Support | Experimental | 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. Receives: Behavioral: Cell Phone Support |
| Live Text Support | Experimental | 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. Receives: Behavioral: Cell Phone Support |
| Automated Text Reminders | Active comparator | 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." Receives: Behavioral: Cell Phone Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Medication Adherence
percentage of doses taken out of 100%, reported by the adolescent or young adult, assessed using a visual analogue scale
Measured: 12 weeks
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
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Aug 2020
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will randomly assign participants to cell phone support by voice, cell phone support by text message, or automated text reminders.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- 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
- NCT04241627
- Sponsor's protocol ID
- CHLA-20-00168
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2020
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belzer ME, Naar-King S, Olson J, Sarr M, Thornton S, Kahana SY, Gaur AH, Clark LF; Adolescent Medicine Trials Network for HIV/AIDS Interventions. The use of cell phone support for non-adherent HIV-infected youth and young adults: an initial randomized and controlled intervention trial. AIDS Behav. 2014 Apr;18(4):686-96. doi: 10.1007/s10461-013-0661-3.
PubMed 24271347Sayegh CS, Szmuszkovicz JR, Menteer J, Sherer S, Thomas D, Lestz R, Belzer M. Cell phone support to improve medication adherence among solid organ transplant recipients. Pediatr Transplant. 2018 Jun 19:e13235. doi: 10.1111/petr.13235. Online ahead of print.
PubMed 29920879Sayegh CS, MacDonell KK, Iverson E, Beard B, Chang N, Vu MH, Belzer M. Randomized pilot trial of cell phone support to improve medication adherence among adolescents and young adults with chronic health conditions. BMC Digit Health. 2024;2(1):13. doi: 10.1186/s44247-024-00069-w. Epub 2024 Mar 19.
PubMed 39211575
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Intervention to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
- ClinicalTrials.gov ID
- NCT04241627
- Acronym / sponsor ID
- CHLA-20-00168
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- We will randomly assign participants to cell phone support by voice, cell phone support by text message, or automated text reminders.
| Arm | Type | Receives |
|---|---|---|
| Cell Phone Support | Experimental | Behavioral: Cell Phone SupportAn 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. |
| Live Text Support | Experimental | Behavioral: Cell Phone SupportAn 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. |
| Automated Text Reminders | Active comparator | Behavioral: Cell Phone SupportThe 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." |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria will include cognitive impairment that precludes participants from engaging in the consent/assent process or study protocol.
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 |
|---|---|---|
| Cell Phone SupportAlso: Live Text SupportCell 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. | Behavioural | Automated Text Reminders, Cell Phone Support, Live Text Support |
Primary outcome
Self-Reported Medication Adherence
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24271347Belzer ME, Naar-King S, Olson J, Sarr M, Thornton S, Kahana SY, Gaur AH, Clark LF; Adolescent Medicine Trials Network for HIV/AIDS Interventions. The use of cell phone support for non-adherent HIV-infected youth and young adults: an initial randomized and controlled intervention trial. AIDS Behav. 2014 Apr;18(4):686-96. doi: 10.1007/s10461-013-0661-3.
- Results publication: PubMed 29920879Sayegh CS, Szmuszkovicz JR, Menteer J, Sherer S, Thomas D, Lestz R, Belzer M. Cell phone support to improve medication adherence among solid organ transplant recipients. Pediatr Transplant. 2018 Jun 19:e13235. doi: 10.1111/petr.13235. Online ahead of print.
- Derived from this study: PubMed 39211575Sayegh CS, MacDonell KK, Iverson E, Beard B, Chang N, Vu MH, Belzer M. Randomized pilot trial of cell phone support to improve medication adherence among adolescents and young adults with chronic health conditions. BMC Digit Health. 2024;2(1):13. doi: 10.1186/s44247-024-00069-w. Epub 2024 Mar 19.
- Individual participant dataSharing planned: No
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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 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 1 inclusion and 1 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 8 Jan 2024. 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 15 Jun 2023). 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?
Self-Reported Medication Adherence (time frame: 12 weeks). The study lists 2 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 NCT04241627, which also lists 3 linked publications.
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 8 Jan 2024.