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

NCT ID: NCT06230978

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Medication Adherence Habits

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of care

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

Group Type ACTIVE_COMPARATOR

Standard Medication Counseling

Intervention Type BEHAVIORAL

The pharmacist provides standard counseling on the new medication

Habit workup arm

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

Group Type EXPERIMENTAL

Habit workup

Intervention Type 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

Intervention Type BEHAVIORAL

The pharmacist provides standard counseling on the new medication

Interventions

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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).

Intervention Type BEHAVIORAL

Standard Medication Counseling

The pharmacist provides standard counseling on the new medication

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Matthew J. Witry

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Waterloo, Iowa, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew J Witry, PhD

Role: CONTACT

319-335-8763

Cole Chapman, PhD

Role: CONTACT

319-467-1705

Facility Contacts

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James Hoehns, PharmD

Role: primary

319-233-1540

References

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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. 2025 Sep 6:S1551-7411(25)00451-6. doi: 10.1016/j.sapharm.2025.09.003. Online ahead of print.

Reference Type DERIVED
PMID: 40946014 (View on PubMed)

Other Identifiers

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202311617

Identifier Type: -

Identifier Source: org_study_id

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