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

Not Applicable

Recruiting

• Conditions: Medication Adherence; Habits
• Interventions: Behavioral: Habit workup; Behavioral: Standard Medication Counseling

• Registration Number: NCT06230978
• Lead Sponsor: University of Iowa

Brief Summary

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?

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-01-30
• Study Start: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-12-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

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Exclusion Criteria

• Does not manage their own medications independently

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Habit workup arm	Standard Medication Counseling	The second 16 patients will receive the habit workup in addition to medication counseling
Standard of care	Standard Medication Counseling	The first 16 patients will receive standard medication counseling from the pharmacist
Habit workup arm	Habit workup	The second 16 patients will receive the habit workup in addition to medication counseling

Primary Outcome Measures

Name	Time	Method
Medication Adherence Report Scale	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)
4-item Habit Automaticity Index	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 Outcome Measures

Name	Time	Method
Beliefs about Medicines Questionnaire	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)

Trial Locations

Locations (1)

Cedar Valley Primary Care & Walk-In Clinic | Waterloo IA; 🇺🇸 Waterloo, Iowa, United States