Medication AdherenceNCT06230978
Evaluation of a Habit-based Work-up to Support Medication Adherence
A study testing Habit workup and Standard Medication Counseling in people with Medication Adherence and Habits, run by University of Iowa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Habits
- What is being tested?
- Habit workup and Standard Medication Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be fluent to speak and write in English,
- must be prescribed a new chronic medication
Who cannot join
- Does not manage their own medications independently
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedar Valley Primary Care & Walk-In Clinic | Waterloo IA
Waterloo, Iowa, 50701
About this study
Official title: 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?
Read the 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.
- Conditions
- Medication Adherence, Habits
- Being tested
- Habit workup, Standard Medication Counseling
- Keywords
- Medication adherence, Habit, Medication Beliefs, Pharmacist
- Medical subject headings
- Medication Adherence, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habit workupBehavioural
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 CounselingBehavioural
The pharmacist provides standard counseling on the new medication
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | The first 16 patients will receive standard medication counseling from the pharmacist Receives: Behavioral: Standard Medication Counseling |
| Habit workup arm | Experimental | The second 16 patients will receive the habit workup in addition to medication counseling Receives: Behavioral: Habit workup; Behavioral: Standard Medication Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: From enrollment to 100 days following
Secondary outcomes (1)
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)
Measured: From enrollment to 100 days following
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Apr 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Witry, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230978
- Sponsor's protocol ID
- 202311617
- Status last verified
- May 2024
- First submitted
- 19 Jan 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on primary and secondary outcomes, and basic demographic information
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.
PubMed 40946014
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Habit-based Work-up to Support Medication Adherence in Primary Care
- ClinicalTrials.gov ID
- NCT06230978
- Acronym / sponsor ID
- 202311617
- Conditions
- Medication Adherence, Habits
- Keywords
- Medication adherence, Habit, Medication Beliefs, Pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Behavioral: Standard Medication CounselingThe first 16 patients will receive standard medication counseling from the pharmacist |
| Habit workup arm | Experimental | Behavioral: Habit workup, Behavioral: Standard Medication CounselingThe second 16 patients will receive the habit workup in addition to medication counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be fluent to speak and write in English,
- must be prescribed a new chronic medication
Key exclusion criteria (1 listed)
- Does not manage their own medications independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habit workupThe 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). | Behavioural | Habit workup arm |
| Standard Medication CounselingThe pharmacist provides standard counseling on the new medication | Behavioural | Habit workup arm, Standard of care |
Primary outcome
Medication Adherence Report Scale
Time frame: From enrollment to 100 days following
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)
4-item Habit Automaticity Index
Time frame: From enrollment to 100 days following
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)
1 secondary outcome
Beliefs about Medicines Questionnaire
Time frame: From enrollment to 100 days following
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 40946014Witry 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.
- Individual participant dataSharing planned: Yes. Data on primary and secondary outcomes, and basic demographic information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habit workup and Standard Medication Counseling in people with Medication Adherence and Habits, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Report Scale (time frame: From enrollment to 100 days following). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.