Mobile Health Interventions for Medication Adherence

(ACPS Trial)

Overseen By Caitlin S Sayegh, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must be taking: Oral medications

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mobile health tool can help young people adhere to their medication routines. It aims to identify the best design for mobile support, such as reminders and coaching, tailored to individual needs. The trial compares personalized support (Adaptive Cell Phone Support) with simple text reminders (Automated Text Reminders) to determine which is more effective. Patients at Children's Hospital Los Angeles, aged 15-20, who speak English and take daily medication for a chronic health issue, may be eligible. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions that could enhance medication adherence for young people.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on helping you stick to your medication schedule, so it's likely you will continue your current medications.

What prior data suggests that this mobile health intervention is safe for promoting medication adherence?

Research has shown that mobile apps, like the one under study, are safe and effective for helping people remember to take their medication. A small initial study found that mobile health coaching helped people adhere to their prescribed medication regimen, with no reports of serious side effects from using these apps.

Another study found that mobile technology aids in medication management and health improvement, particularly for individuals with heart disease. Mobile reminders and coaching did not cause any harm. Overall, using a phone app to assist with medication adherence is safe and well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Adaptive Cell Phone Support because it offers a fresh take on improving medication adherence. Unlike traditional methods, which often rely on patients remembering their medication schedules, this approach uses technology to provide timely reminders, problem-solving assistance, and access to resources through a mobile app. Additionally, it includes responsive human coaching with personalized phone calls and messages, offering a more engaging and supportive experience. This integration of digital tools with human interaction could make sticking to medication plans easier and more effective for patients.

What evidence suggests that this trial's mobile health interventions could be effective for promoting medication adherence?

Research has shown that mobile health tools can help people take their medication more regularly. One study found that cell phone support, such as reminders and coaching, helped participants stick to their medication schedule. Another study showed that a smartphone app increased users' confidence in managing their medication and provided social support. Additionally, programs lasting six months or more were more effective at keeping people on track with their medication. In this trial, the adaptive cell phone support system, which includes computer-delivered support and responsive human coaching, aims to tailor the level of help to each person. This approach might be more effective than standard text reminders. ^{2 6 7 8 9}

Who Is on the Research Team?

Caitlin Sayegh, PhD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for patients aged 15-20 at Children's Hospital Los Angeles who take daily oral medication for a chronic condition, speak English, and can understand the study. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

I take daily oral medication for a long-term health issue.

Has a cell phone

I am a patient at Children's Hospital Los Angeles aged between 15-20.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Cohort Feedback

An initial cohort of adolescents with chronic health conditions will try the intervention and provide feedback to refine the structure and content

4 weeks

Treatment

Participants are randomized to either automated text reminders or computer-delivered Cell Phone Support, with potential reassignment to Adaptive Cell Phone Support based on response

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Cell Phone Support
• Automated Text Reminders
• Computer-Delivered Cell Phone Support

Trial Overview Researchers are testing mobile health tools to improve how young people with chronic conditions take their meds. They're comparing personalized cell phone support against simple text reminders to see which helps more.

How Is the Trial Designed?

Group I: Adaptive Cell Phone Support Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

The Perx app significantly improved medication adherence among participants over 12 months, with notable increases in adherence rates observed at 2, 3, and 12 months compared to standard care.

Participants using the Perx app also showed better clinical outcomes, including a higher probability of achieving target HbA1c levels and lower cholesterol levels, particularly benefiting those with obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a smartphone application (Perx) on medication adherence and clinical outcomes: a 12-month randomised controlled trial. Li, A., Del Olmo, MG., Fong, M., et al.[2021]

A systematic review of 21 studies on mobile health technology (mHealth) interventions showed that these approaches can improve medication adherence and blood pressure control in people with hypertension, although only 12 studies reported statistically significant improvements.

Most studies included in the review were small and of short duration, indicating a need for further research to assess the long-term effectiveness and applicability of mHealth interventions, especially in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mHealth Interventions in Improving Medication Adherence Among People with Hypertension: a Systematic Review. Xiong, S., Berkhouse, H., Schooler, M., et al.[2019]

The pilot study involving 29 women with metastatic breast cancer demonstrated that the CONnected CUstomized Treatment Platform effectively maintained a high palbociclib adherence rate of 95.8%, indicating its potential for improving medication compliance.

Despite the high adherence rate, participants reported no significant changes in symptom burden or quality of life over three months, suggesting that while the intervention is feasible, further improvements in usability are needed to enhance overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study. Sadigh, G., Meisel, JL., Byers, K., et al.[2023]

A randomized controlled trial with 161 participants showed that real-time monitoring combined with SMS reminders significantly improved refill adherence to oral anti-diabetic medication after 1 year (79.5% vs. 64.5% in the control group).

The effectiveness of the SMS reminder system persisted after 2 years, maintaining higher adherence rates compared to the control group, while the non-SMS group saw a decline back to baseline levels, highlighting the importance of reminders in medication management for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term effects of real-time medication monitoring with short message service (SMS) reminders for missed doses on the refill adherence of people with Type 2 diabetes: evidence from a randomized controlled trial. Vervloet, M., van Dijk, L., de Bakker, DH., et al.[2022]

A systematic review of 9 randomized controlled trials involving 1159 participants found that app-based interventions significantly improve medication adherence, with users being over twice as likely to report adherence compared to those receiving usual care or non-BCT apps.

Despite the positive impact on adherence, the study did not find specific behavior change techniques (BCTs) that were consistently associated with greater efficacy, indicating a need for further research to identify effective strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do mobile device apps designed to support medication adherence demonstrate efficacy? A systematic review of randomised controlled trials, with meta-analysis. Armitage, LC., Kassavou, A., Sutton, S.[2021]

Text message reminders (TMR) significantly improved medication adherence among 1678 patients with coronary heart disease, showing a 2.85 times greater adherence rate compared to the control group.

TMR also led to notable reductions in systolic blood pressure and cholesterol levels, contributing to better clinical outcomes, although it did not affect mortality or diastolic blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis. Zhao, YY., Dang, FP., Zhai, TT., et al.[2022]

A systematic review of 14 studies involving 1,785 participants found that mobile applications significantly improve medication adherence in adults with chronic diseases, with a moderate effect size (Cohen's d = 0.40).

Participants reported high satisfaction with the mobile apps, with 91.7% expressing contentment with all aspects, indicating that these tools are not only effective but also well-received by users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Applications on Medication Adherence in Adults with Chronic Diseases: A Systematic Review and Meta-Analysis. Peng, Y., Wang, H., Fang, Q., et al.[2023]

A systematic review of 272 medication reminder apps revealed that while many are available, most lack desirable features, with only 18 apps meeting at least 9 out of 17 key criteria for quality.

The review identified that advanced medication reminder apps, which make up 54.8% of the total, offer more features and higher quality ratings compared to basic apps, highlighting the need for users to choose wisely for better medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Apps to Improve Medication Adherence: A Systematic Stepwise Process to Identify High-Quality Apps. Santo, K., Richtering, SS., Chalmers, J., et al.[2022]

The study demonstrated that using a handheld Medication Event Reporting Tool (MERT) is a feasible way to capture self-reported medication events among healthcare providers, with 76 events reported over 2,311 days of participation.

Nurses reported medication events at a higher rate than physicians, and attending physicians reported events more frequently than resident physicians, suggesting that the tool could enhance medication safety monitoring in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a handheld computer application for voluntary medication event reporting by inpatient nurses and physicians. Dollarhide, AW., Rutledge, T., Weinger, MB., et al.[2021]

A systematic review of 17 studies found that mobile health (mHealth) interventions significantly improved statin adherence in 12 of the studies, indicating that these digital tools can effectively support patients in managing cardiovascular disease.

Effective mHealth interventions often employed multiple behavior-change techniques (BCTs), such as goal setting, providing instructions, and using credible sources, suggesting that a multifaceted approach is key to enhancing medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of RCTs Assessing the Effectiveness of mHealth Interventions to Improve Statin Medication Adherence: Using the Behaviour-Change Technique Taxonomy to Identify the Techniques That Improve Adherence. Bond, Z., Scanlon, T., Judah, G.[2021]

A systematic review of 13 studies involving patients with various cardiovascular diseases found that mobile health (mHealth) interventions significantly improved dietary adherence in 8 of the studies, indicating their potential effectiveness in managing cardiovascular health.

Interactive features, such as text messaging and app-based tools, were particularly effective in enhancing dietary adherence, suggesting that these characteristics should be prioritized in future mHealth interventions for patients with cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mHealth Interventions on Supporting Dietary Adherence in Cardiovascular Disease: A Systematic Review. Thom, SJM., Sivakumar, B., Ayodele, T., et al.[2023]

Mobile phone-based self-management interventions significantly reduced diastolic blood pressure in patients with coronary heart disease, with a mean difference of -1.99 mmHg based on 11 meta-analysed trials.

While these interventions showed promise for improving self-management, they did not have a statistically significant effect on medication adherence or systolic blood pressure, indicating the need for better-designed studies to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile phone-based self-management interventions for medication adherence and change in blood pressure in patients with coronary heart disease: A systematic review and meta-analysis. Sua, YS., Jiang, Y., Thompson, DR., et al.[2021]

In a study involving 1372 participants with high blood pressure, automated SMS text message support led to a small but significant reduction in systolic blood pressure compared to usual care, with a mean change of -2.2 mm Hg for information-only messages.

Both information-only and interactive SMS messaging improved the odds of achieving blood pressure control (<140/90 mm Hg) compared to usual care, but the interactive approach did not provide additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial. Bobrow, K., Farmer, AJ., Springer, D., et al.[2022]

A systematic review of 20 studies, including 13 randomized clinical trials, found that mobile health (mHealth) interventions, primarily through SMS reminders, improved medication adherence in 65% of cases among various patient populations, including those with chronic diseases and HIV.

Despite the positive outcomes, the evidence was mixed due to the diversity of study designs and the predominance of trials conducted in high-income countries, highlighting the need for more high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does mHealth increase adherence to medication? Results of a systematic review. Anglada-Martinez, H., Riu-Viladoms, G., Martin-Conde, M., et al.[2018]

Citations

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Evaluating the Effectiveness of Mobile Apps on Medication ... Adherence attributes include tracking taken and missed doses, specific medication reminders that are customizable, and medical social networking ...

2. bmcdigitalhealth.biomedcentral.com bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00069-w

Randomized pilot trial of cell phone support to improve ... This pilot trial evaluated the impact of a mobile health coaching intervention, Cell Phone Support (CPS), on medication adherence.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11026187/

Effects of a medication adherence app among ... This study investigated the effect of a smartphone app on adherence, self-efficacy, knowledge, and medication social support in a medically underserved adult ...

4. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1632474/epub

Digital interventions in medication adherence Interventions lasting 6 months or longer were more effective than those that are shorter term (Belete et al., 2023), and tapering for an ...

5. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/improving-adherence-and-outcomes-artificial-intelligence-adapted-text-messages

Improving Adherence and Outcomes by Artificial Intelligence ... Examine the potential efficacy of the RL-based adaptive SMS intervention with respect to improvements in medication adherence and systolic blood pressure. In ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6604503/

Mobile Apps for Increasing Treatment Adherence The use of mobile apps helps increase treatment adherence, and they are an appropriate method for managing medication at home.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0019483222000530

The effect of mobile application-based technology use on ... Mobile application-based technology was used to study medication compliance and influence on cardiovascular lifestyle in ischemic heart disease (IHD) patients.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK563120/

Mobile Monitoring and Intervention (MMI) Technology ... - NCBI Monitoring (e.g., smart caps for bottled prescriptions) and intervention (prompts to the target person) can be used to help people with medication adherence ...

9. frontiersin.org frontiersin.org/journals/medical-technology/articles/10.3389/fmedt.2020.616242/full

Digital Medication Adherence Support: Could Healthcare ... Adherence to prescribed medication is suboptimal in 50 % of the chronic population, resulting in negative medical and economic outcomes.