Habit-Based Counseling for Medication Adherence

Overseen By Cole Chapman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must be taking: Chronic medications

Disqualifiers: Not managing own medications

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

Compensation: Varies

Number of Visits: 2

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special habit worksheet and a chat with a pharmacist can help people remember to take new chronic medications for heart disease or depression. It compares this approach with the usual guidance from pharmacists. Researchers aim to determine if this new method improves adherence to medication schedules and alters beliefs about taking medications. Participants who have recently started a long-term prescription and manage their own medications may be a good fit. As an unphased trial, this study offers a unique opportunity to explore new ways to improve medication adherence and potentially enhance health management.

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 patients who are starting a new chronic medication for cardiovascular disease or depression.

What prior data suggests that this habit workup is safe for patients?

Research has shown that habit-based methods, like the one in this trial, are generally safe. The studies reported no serious side effects. This approach focuses on helping people remember to take their medicine, rather than introducing new medication.

Previous studies have examined whether these habit tools help people take their medicine more regularly. So far, they seem promising and do not cause harm. This trial provides an opportunity to determine if using these habit tools truly helps people establish a routine for taking their medicine. The method is well-tolerated, as it primarily involves discussions with a pharmacist and using a worksheet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Habit-Based Counseling for Medication Adherence because it introduces a novel approach to helping patients stick to their medication regimens. Unlike standard medication counseling, which typically focuses on providing information about the medication, the habit workup arm of this trial adds a personalized habit-building strategy. This approach aims to create lasting behavioral changes by integrating medication routines into the patient's daily life more effectively. By focusing on habit formation, this method could enhance adherence and improve health outcomes, offering a fresh perspective compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for improving medication adherence?

This trial will compare two approaches to medication adherence. The Habit workup arm, which participants in this trial may receive, involves developing strong medication habits to help patients take their medication on time. Research has shown that stronger habits increase the likelihood of taking medication as directed. One study suggested that focusing on habits might be more effective than other methods for improving adherence. Meanwhile, the Standard of care arm involves standard medication counseling. Overall, creating a routine around taking medication appears promising in helping patients manage their health better. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who have recently been prescribed a new chronic medication for cardiovascular disease or depression and manage their own medications independently.

Inclusion Criteria

I have been prescribed a new long-term medication.

Participants must be fluent to speak and write in English

Exclusion Criteria

I need help managing my medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard of Care

The first 16 patients receive standard medication counseling from the pharmacist

Approximately 14 weeks

1 visit (in-person)

Habit Workup

The second 16 patients receive the habit workup in addition to medication counseling

Approximately 14 weeks

1 visit (in-person)

Follow-up

Participants are monitored for medication adherence and habit formation

100 days

What Are the Treatments Tested in This Trial?

Interventions

• Habit workup
• Standard Medication Counseling

Trial Overview

The study tests the effectiveness of a habit-forming worksheet and pharmacist discussion versus standard medication counseling in helping patients develop habits to take their medicine regularly.

How Is the Trial Designed?

Group I: Habit workup arm Experimental Treatment 2 Interventions

The second 16 patients will receive the habit workup in addition to medication counseling

Group II: Standard of care Active Control 1 Intervention

The first 16 patients will receive standard medication counseling from the pharmacist

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Published Research Related to This Trial

Counseling during a simulated medication adherence activity significantly reduced the incidence of simulated food-drug interactions, with 22% in the counseling group compared to 30% in the group without counseling.

The majority of students (70%) found the activity valuable, and 89% felt it improved their understanding of medication adherence challenges, highlighting the importance of counseling in enhancing adherence education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Potential Impact of Pharmacist Counseling on Medication Adherence Using a Simulation Activity. Volino, LR., Das, RP., Mansukhani, RP., et al.[2023]

Medication counseling that emphasizes auxiliary labels can improve patients' recall of important medication information, with a high recall rate of 77% observed in a study of 50 adults receiving antibiotics.

Most misunderstandings were related to dietary restrictions, indicating a need for further research and targeted counseling in this area to enhance adherence to medication schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled study of an educational intervention to improve recall of auxiliary medication labeling and adherence to antibiotics. Pham, JA., Pierce, W., Muhlbaier, L.[2020]

Therapeutic adherence, which includes following medication regimens and lifestyle changes, is crucial for improving health outcomes, but is often hindered by over 200 factors that can lead to increased health complications and costs.

Effective interventions to improve adherence focus on cognitive education, behavioral changes, and motivation, with an emphasis on empowering patients to take responsibility for their own health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Modifying habits and treatment adherence, essential for controlling the chronic disease]. Pisano González, MM., González Pisano, A.[2014]

Only 50% of patients adhere to their long-term medication regimens, highlighting a significant challenge in managing chronic conditions.

A review of 15 randomized controlled trials revealed that while habit formation is a recognized concept in behavior change, only six studies explicitly incorporated techniques for promoting habit formation in medication adherence interventions, indicating a gap in the literature that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A machine-learning assisted review of the use of habit formation in medication adherence interventions for long-term conditions. Robinson, L., Arden, MA., Dawson, S., et al.[2022]

The study evaluated the impact of patient self-completion concordance forms on medication adherence among patients starting new chronic treatments, involving a randomized control trial design.

After 6 months, both the intervention group (using concordance forms) and the control group showed similar adherence rates of 79%, indicating that the concordance forms did not significantly improve adherence compared to standard counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of an intervention based on the application of patient self-completion concordance forms in Dutch community pharmacies and the effect on adherence to chronic medication. Geurts, MM., Pot, JL., Schepers, EH., et al.[2019]

Nonadherence to medication is influenced by various factors, including healthcare systems, provider interactions, patient characteristics, and the nature of the illness, highlighting the complexity of improving adherence rates.

The article proposes a brief counseling model for pharmacists, supported by empirical evidence, to enhance medication adherence and discusses the economic impact of nonadherence, suggesting that effective counseling can reduce healthcare costs associated with increased medical visits and hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence With Therapeutic Regimens: Behavioral and Pharmacoeconomic Perspectives. Giannetti, VJ., Kamal, KM.[2016]

Cognitive-based behavior change techniques, particularly Motivational Interviewing, significantly improve medication adherence, with a meta-analysis of 26 studies involving 5216 participants showing a notable effect size of 0.34.

These interventions can be effectively delivered by healthcare providers in community settings and are adaptable for various populations, suggesting they can be easily integrated into routine care to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of cognitive-based behaviour change techniques as interventions to improve medication adherence. Easthall, C., Song, F., Bhattacharya, D.[2023]

A new method to measure medication adherence habit was developed using electronic data capture, creating a 'habit index' based on the frequency of behavior and context stability, which can help predict future adherence.

In a study of 123 adults with cystic fibrosis over 153 weeks, the habit index showed a moderate correlation (R = 0.40) with future nebulizer adherence, suggesting it could be a useful tool for understanding and improving medication habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic behavior-based habit index for adherence to nebulized treatments among adults with cystic fibrosis. Hoo, ZH., Wildman, MJ., Campbell, MJ., et al.[2022]

Self-report measures of medication adherence are commonly used but often overestimate actual adherence compared to other methods, showing high specificity but low sensitivity.

Despite their limitations, self-reports can still provide valuable insights into adherence behavior and are preferred in clinical settings for their speed and cost-effectiveness, especially when using validated scales and improved methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-report measures of medication adherence behavior: recommendations on optimal use. Stirratt, MJ., Dunbar-Jacob, J., Crane, HM., et al.[2022]

Nonadherence to medication regimens in clinical trials can significantly impact the validity of study results, with reported adherence rates ranging from 60% to 90%.

Using a drug marker in behavioral counseling can help identify and address adherence issues, but it is crucial for clinicians to carefully consider how they introduce this information to maintain a positive relationship with participants and effectively improve adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral aspects of the use of medical markers in clinical trials. Russell, ML.[2019]

Citations

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Development of a Digital Intervention Incorporating Habit ...

This study aimed to develop and validate personalized interventions, using technological tools, designed to support medication habit formation in patients with ...

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pmc.ncbi.nlm.nih.gov

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Habit Strength, Medication Adherence, and Habit-Based ...

Habit strength was strongly correlated with medication adherence, and stronger habit was associated with higher medication adherence rates.

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Correlation Between Objective Habit Metrics and ...

We aim to explore the correlation between objective habit metrics and objective medication adherence on a large dataset.

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bmjopen.bmj.com

bmjopen.bmj.com/content/11/11/e055930

Randomised controlled trial targeting habit formation to ...

Existing interventions to improve medication adherence have only been moderately effective. Habit formation theory is a promising strategy to improve adherence.

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tandfonline.com/doi/full/10.1080/17437199.2022.2034516

A machine-learning assisted review of the use of habit ...

A machine-learning assisted review of the use of habit formation in medication adherence interventions for long-term conditions.

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The goal of this clinical trial is to test the impact of a medication-taking habit worksheet and discussion with a pharmacist in patients who ...

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Evaluating Objective Metrics of habit strength for taking ...

As a stronger medication-taking habit has been shown to be associated with a better medication adherence [4,10, 11, 12,13], in particular its ...