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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230978
• Other study ID #: 202311617
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Matthew J Witry, PhD
• Phone: 319-335-8763
• Email: matthew-witry[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Habits
• Medication Adherence

Intervention

Behavioral:
• Habit workup
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
The pharmacist provides standard counseling on the new medication

Locations

Country	Name	City	State
United States	Cedar Valley Primary Care & Walk-In Clinic | Waterloo IA	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence Report Scale	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)	From enrollment to 100 days following
Primary	4-item Habit Automaticity Index	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)	From enrollment to 100 days following
Secondary	Beliefs about Medicines Questionnaire	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)	From enrollment to 100 days following