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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Adaptive Cell Phone Support, Automated Text Reminders, Computer-Delivered Cell Phone Support for medication adherence?

Research shows that mobile health interventions, like automated text reminders, can significantly improve medication adherence. Studies found that using automated phone messages and setting goals with patients were effective in helping people stick to their medication routines. ^{1 2 3 4 5}

Is it safe to use mobile health interventions like text reminders and apps for medication adherence?

Research on mobile health interventions, such as text message reminders and smartphone apps, shows they are generally safe for helping people remember to take their medications. These tools have been tested in various studies without reports of harm, focusing on improving medication adherence for conditions like diabetes and high blood pressure. ^{6 7 8 9 10}

How is the Adaptive Cell Phone Support treatment different from other treatments for medication adherence?

Adaptive Cell Phone Support is unique because it uses mobile health technology to improve medication adherence by providing personalized support through a connected platform, which includes features like electronic monitoring and automated texting, making it more interactive and potentially more effective than traditional methods. ^{2 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Caitlin Sayegh, PhD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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.

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

Has a cell phone

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Computer-Delivered Cell Phone Support Experimental Treatment 1 Intervention

Computer-delivered cell phone support (reminders, problem-solving, referrals to resources)

Group II: Adaptive Cell Phone Support Experimental Treatment 2 Interventions

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.

Group III: Automated Text Reminders Active Control 1 Intervention

Scheduled one-way text automated message reminders to take medication

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Findings from Research

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 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]

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]

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 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]

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 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]

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]

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 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 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 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]

References

1. Switzerland 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of mHealth Interventions in Improving Medication Adherence Among People with Hypertension: a Systematic Review. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of mHealth Interventions on Supporting Dietary Adherence in Cardiovascular Disease: A Systematic Review. [2023]

4. England 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. [2021]

5. United States 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. [2022]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effect of a smartphone application (Perx) on medication adherence and clinical outcomes: a 12-month randomised controlled trial. [2021]

8. England 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Use of a handheld computer application for voluntary medication event reporting by inpatient nurses and physicians. [2021]

10. United States 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Applications on Medication Adherence in Adults with Chronic Diseases: A Systematic Review and Meta-Analysis. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

Mobile Phone Apps to Improve Medication Adherence: A Systematic Stepwise Process to Identify High-Quality Apps. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study. [2023]

14. India pubmed.ncbi.nlm.nih.gov

Does mHealth increase adherence to medication? Results of a systematic review. [2018]