Clinical trial NCT06230978: Evaluation of a Habit-based Work-up to Support Medication Adherence
Official title: Evaluation of a Habit-based Work-up to Support Medication Adherence in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Adherence
Habits
Keywords: Medication adherence
Habit
Medication Beliefs
Pharmacist
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Adherence Report Scale
timeFrame: From enrollment to 100 days following
measure: 4-item Habit Automaticity Index
timeFrame: From enrollment to 100 days following
Secondary outcomes:
measure: Beliefs about Medicines Questionnaire
timeFrame: From enrollment to 100 days following
Other outcomes:
Locations:
city: Waterloo
country: United States
facility: Cedar Valley Primary Care & Walk-In Clinic | Waterloo IA
state: Iowa
Study officials:
References: