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Completed

NCT Number: NCT06230978

Evaluation of a Habit-based Work-up to Support Medication Adherence

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedar Valley Primary Care & Walk-In Clinic | Waterloo IA

Waterloo, Iowa, 50701, United States

About this study

The purpose of this study is to evaluate a habit adherence workup delivered by pharmacy in primary care. The study population will include patients taking new medications for chronic conditions like high blood pressure, high cholesterol, diabetes, and depression.

This study uses a sequential design which involves first evaluating 16 patients without the added habit worksheet, and then the second phase evaluates 16 patients with the habit worksheet. All participants meet with the pharmacist and are provided standard counseling on the new medications. All participants complete the pre and post survey.

The pharmacist will be trained on the medication habit workup worksheet which has the patient choose cues they will use to develop their medication-taking habit. These will include associating the new habit with hygiene habits like toothbrushing, other habits like making coffee or eating breakfast, or visual cues like setting medications out where they will be easily noticed when doing other habits like getting dressed. Patients will take their sheet with them as a reminder of their plan. Patients also will receive medication counseling. The encounters will occur in a private clinic room.

All participants will complete baseline and follow-up surveys, which will include space for open-ended comments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be fluent to speak and write in English,
  • must be prescribed a new chronic medication

Exclusion criteria

  • Does not manage their own medications independently

Treatment and study plan

Habit workup

Behavioral

The patient and pharmacist will work together to specify a cue to help them take their medicine every day (e.g. brushing teeth, getting dressed, eating breakfast, making coffee, alarms, visual reminders etc).

Standard medication counseling

Behavioral

The pharmacist provides standard counseling on the new medication

Primary outcomes

  1. Medication Adherence Report Scale

    Time frame: From enrollment to 100 days following

    Five-items from the medication Adherence Report scale assessed using 5-point Likert scale. Possible range 5-25 (higher values associated with greater medication adherence)

  2. 4-item Habit Automaticity Index

    Time frame: From enrollment to 100 days following

    This 4 scale uses four validated items from the Habit Automaticity Index and uses a 5-point Likert scale. Possible range 4-20 (higher values associated with greater automaticity of medication-taking habit)

Secondary outcomes

  1. Beliefs about Medicines Questionnaire

    Time frame: From enrollment to 100 days following

    For this study,, 5 items specific, 5 items general from the beliefs about Medicines questionnaire by Horne. Possible range 5-25 for each scale. (for the specific beliefs, lower values are associated with more positive medication beliefs, with the general, higher numbers are associated with greater medication beliefs)

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Evaluation of a Habit-based Work-up to Support Medication Adherence in Primary Care

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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