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

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

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?

Study Overview

• Status: Completed
• Conditions: Medication Adherence; Habits
• Intervention / Treatment: Behavioral: Standard Medication Counseling; Behavioral: Habit workup

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Waterloo, Iowa, United States, 50701
      • Cedar Valley Primary Care & Walk-In Clinic | Waterloo IA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; The first 16 patients will receive standard medication counseling from the pharmacist	Behavioral: Standard Medication Counseling; The pharmacist provides standard counseling on the new medication
Experimental: Habit workup arm; The second 16 patients will receive the habit workup in addition to medication counseling	Behavioral: Standard Medication Counseling; The pharmacist provides standard counseling on the new medication; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Iowa

Publications and helpful links

General Publications

• Witry M, Hoehns J, Phillips LA. Pilot of a pharmacist-delivered habit-based intervention to support medication adherence in primary care. Res Social Adm Pharm. 2026 Jan;22(1):147-151. doi: 10.1016/j.sapharm.2025.09.003. Epub 2025 Sep 6.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Medication adherence; Pharmacist; Habit; Medication Beliefs
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Medication Adherence; Habits
• Other Study ID Numbers: 202311617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data on primary and secondary outcomes, and basic demographic information
• IPD Sharing Time Frame: 1 year following the close of the study.
• IPD Sharing Access Criteria: They can email the principle investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No