Nctid:
NCT06230978
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"HEALTH_SERVICES_RESEARCH", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>32}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2025-08-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-10", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-14", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Medication Adherence Report Scale", "timeFrame"=>"From enrollment to 100 days following", "description"=>"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)"}, {"measure"=>"4-item Habit Automaticity Index", "timeFrame"=>"From enrollment to 100 days following", "description"=>"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)"}], "secondaryOutcomes"=>[{"measure"=>"Beliefs about Medicines Questionnaire", "timeFrame"=>"From enrollment to 100 days following", "description"=>"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)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Medication adherence", "Habit", "Medication Beliefs", "Pharmacist"], "conditions"=>["Medication Adherence", "Habits"]}, "descriptionModule"=>{"briefSummary"=>"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:\n\n* What is the feasibility and acceptability of the workup from the perspective of the patients and the clinic?\n* What is the impact of the intervention on the formation of medication-taking habits compared to a comparison group who receive standard pharmacist counseling?\n* What is the difference in medication adherence beliefs and behaviors for the group receiving the habit workup compared to those receiving standard counseling?", "detailedDescription"=>"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.\n\nThis 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.\n\nThe 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.\n\nAll participants will complete baseline and follow-up surveys, which will include space for open-ended comments."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Participants must be fluent to speak and write in English,\n* must be prescribed a new chronic medication\n\nExclusion Criteria:\n\n* Does not manage their own medications independently"}, "identificationModule"=>{"nctId"=>"NCT06230978", "briefTitle"=>"Evaluation of a Habit-based Work-up to Support Medication Adherence", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Iowa"}, "officialTitle"=>"Evaluation of a Habit-based Work-up to Support Medication Adherence in Primary Care", "orgStudyIdInfo"=>{"id"=>"202311617"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Standard of care", "description"=>"The first 16 patients will receive standard medication counseling from the pharmacist", "interventionNames"=>["Behavioral: Standard Medication Counseling"]}, {"type"=>"EXPERIMENTAL", "label"=>"Habit workup arm", "description"=>"The second 16 patients will receive the habit workup in addition to medication counseling", "interventionNames"=>["Behavioral: Habit workup", "Behavioral: Standard Medication Counseling"]}], "interventions"=>[{"name"=>"Habit workup", "type"=>"BEHAVIORAL", "description"=>"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).", "armGroupLabels"=>["Habit workup arm"]}, {"name"=>"Standard Medication Counseling", "type"=>"BEHAVIORAL", "description"=>"The pharmacist provides standard counseling on the new medication", "armGroupLabels"=>["Habit workup arm", "Standard of care"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"50701", "city"=>"Waterloo", "state"=>"Iowa", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"James Hoehns, PharmD", "role"=>"CONTACT", "email"=>"jhoehns@gmail.com", "phone"=>"319-233-1540"}, {"name"=>"James Hoehns, PharmD", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Cedar Valley Primary Care & Walk-In Clinic | Waterloo IA", "geoPoint"=>{"lat"=>42.49276, "lon"=>-92.34296}}], "centralContacts"=>[{"name"=>"Matthew J Witry, PhD", "role"=>"CONTACT", "email"=>"matthew-witry@uiowa.edu", "phone"=>"319-335-8763"}, {"name"=>"Cole Chapman, PhD", "role"=>"CONTACT", "email"=>"cole-chapman@uiowa.edu", "phone"=>"319-467-1705"}]}, "ipdSharingStatementModule"=>{"url"=>"https://pharmacy.uiowa.edu/people/matthew-witry", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF"], "timeFrame"=>"1 year following the close of the study.", "ipdSharing"=>"YES", "description"=>"Data on primary and secondary outcomes, and basic demographic information", "accessCriteria"=>"They can email the principle investigator"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Iowa", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor", "investigatorFullName"=>"Matthew J. Witry", "investigatorAffiliation"=>"University of Iowa"}}}}
