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

Trial Summary

What is the purpose of this trial?

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 are prescribed a new chronic medication for cardiovascular disease or depression. The main questions it aims to answer are: * What is the feasibility and acceptability of the workup from the perspective of the patients and the clinic? * What is the impact of the intervention on the formation of medication-taking habits compared to a comparison group who receive standard pharmacist counseling? * What is the difference in medication adherence beliefs and behaviors for the group receiving the habit workup compared to those receiving standard counseling?

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 data supports the effectiveness of the treatment Habit-Based Counseling for Medication Adherence?

Research suggests that habit formation, which involves repeating behaviors in specific contexts, can help improve medication adherence. Additionally, pharmacist counseling has been shown to positively impact medication adherence, indicating that similar counseling interventions may be effective. ^{1 2 3 4 5}

Is habit-based counseling for medication adherence safe for humans?

The research articles do not provide specific safety data for habit-based counseling interventions, but generally, counseling methods like these are considered safe as they involve discussions and behavioral strategies rather than physical interventions. ^{1 6 7 8 9}

How is the Habit-Based Counseling for Medication Adherence treatment different from other treatments?

This treatment is unique because it focuses on habit formation to improve medication adherence, using techniques like context-dependent repetition to help patients develop consistent medication-taking behaviors. Unlike other methods, it emphasizes creating lasting habits rather than just providing information or reminders. ^{1 3 5 7 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Evaluating the Potential Impact of Pharmacist Counseling on Medication Adherence Using a Simulation Activity. [2023]

2. Ireland 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A machine-learning assisted review of the use of habit formation in medication adherence interventions for long-term conditions. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of cognitive-based behaviour change techniques as interventions to improve medication adherence. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A randomized, controlled study of an educational intervention to improve recall of auxiliary medication labeling and adherence to antibiotics. [2020]

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

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

8. New Zealand pubmed.ncbi.nlm.nih.gov

A pragmatic behavior-based habit index for adherence to nebulized treatments among adults with cystic fibrosis. [2022]

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

Adherence With Therapeutic Regimens: Behavioral and Pharmacoeconomic Perspectives. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Self-report measures of medication adherence behavior: recommendations on optimal use. [2022]