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

NCT06230978 | Completed

• 1 other identifier: 202311617
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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?

Conditions

Medication Adherence; Habits

Keywords

Medication adherence; Habit; Medication Beliefs; Pharmacist

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Beliefs about Medicines Questionnaire

  From enrollment to 100 days following

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

The first 16 patients will receive standard medication counseling from the pharmacist

Behavioral: Standard Medication Counseling

Habit workup arm

EXPERIMENTAL

The second 16 patients will receive the habit workup in addition to medication counseling

Behavioral: Habit workup; Behavioral: Standard Medication Counseling

Interventions

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).

Habit workup arm

Standard Medication Counseling BEHAVIORAL

The pharmacist provides standard counseling on the new medication

Habit workup arm; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Does not manage their own medications independently

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

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

Waterloo, Iowa, 50701, United States

Location

Related Publications (1)

• 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.

  PMID: 40946014 DERIVED

MeSH Terms

Conditions

Medication Adherence; Habits

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: April 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 5, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year following the close of the study.
• Access Criteria: They can email the principle investigator

Locations

US (1)