- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551925
Effect of Occupational Therapy in Promoting Medication Adherence
Effect of Occupational Therapy in Promoting Medication Adherence: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to determine whether the addition of an occupational therapy intervention to counseling by a clinical pharmacist (current usual care) compared to counseling by a clinical pharmacist only, will affect three-month medication adherence rates among community-dwelling adults with uncontrolled hypertension and/or diabetes.
To meet this purpose, the following objectives will be addressed:
- to determine if the addition of the delivery of an occupational therapy intervention (specifically the Integrative Self-Management Intervention) to usual care improves three-month medication adherence rates, as measured by the Adherence to Refills and Medication Scale (ARMS-7), pill count, blood pressure and/or hemoglobin A1c.
- to determine whether the administration of the occupational therapy intervention in addition to usual care influences an individual's readiness for change as measured by the stages of change measure; and
- to explore whether participant demographics (e.g., gender, age, race/ethnicity, assist at home, co-morbidities, and number of medications) impact three-month medication adherence rates.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Springfield, Missouri, United States, 65806
- Jordan Valley Community Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Jordan Valley Community Health Center clients will be considered eligible for inclusion in the study if they are 18 years or older, have a confirmed diagnosis of hypertension, receive a score of less than or equal to 21 on the Adherence to Refills and Medication Scale (ARMS-7) and they provide written informed consent.
Exclusion Criteria:
- Participants will be excluded if they indicate via self-report that they are unable to read or understand spoken English without an interpreter or translator or if they have a medical power of attorney and are unable to provide their own informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment as Usual Plus Occupational Therapy
The occupational therapy intervention will be guided by the Integrative Medication Self-Management Intervention (IMedS).The IMedS process guides the occupational therapist and client through an initial evaluation process and a three-step intervention plan to improve medication management.
|
The IMeds consists of a three-step process that leads the client from the reflection of past performance, to goal setting, and onto strategy identification and implementation.
This intervention guides the client through identifying strategies in the following six areas: altering the medication management activity, advocacy, assistive technology, environmental modifications, and securing refills on time (Schwartz et al., 2017).
Other Names:
|
Active Comparator: Treatment as Usual (TAU)
Participants will receive only the TAU intervention which is provided by a clinical pharmacist and is the protocol at Jordan Valley Community Health Center.
The intervention seeks to improve medication adherence in individuals with hypertension.
|
A clinical pharmacist counsels participants on proper medication adherence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score
Time Frame: The ARMS-7 will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.
|
The ARMS-7 consists of seven questions that provide a self-report of medication adherence.
|
The ARMS-7 will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Stages of Change Measure Score
Time Frame: The stages of change measure will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.
|
A single-item multiple choice question that assesses an individuals current readiness for change.
|
The stages of change measure will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.
|
Change in Pill count
Time Frame: Pill count will be completed approximately every 4 weeks over a 12 week period by the clinical pharmacist.
|
A percentage of adherence can be calculated by pill count which includes dividing the number of doses taken by the number of doses that should have been taken multiplied by 100.
|
Pill count will be completed approximately every 4 weeks over a 12 week period by the clinical pharmacist.
|
Change in Blood pressure
Time Frame: Blood pressure will be taken approximately every 4 weeks over a 12 week period by the clinical pharmacist.
|
Use of the manual auscultatory method for taking blood pressure will be completed by the clinical pharmacist.
Systolic and diastolic blood pressures will be recorded and compared separately.
|
Blood pressure will be taken approximately every 4 weeks over a 12 week period by the clinical pharmacist.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Moore, PhD, University of Indianapolis
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0901 (Ethikkommision KiKli BE)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Treatment as Usual Plus Occupational Therapy
-
National Resource Center for Rehabilitation in...Haukeland University Hospital; St. Olavs Hospital; Haugesund Rheumatism HospitalCompletedOsteoarthritis in the Carpometacarpal (CMC) JointNorway
-
South London and Maudsley NHS Foundation TrustCompletedAttention Deficit Hyperactivity DisorderUnited Kingdom
-
Nagoya City UniversityUnknownPervasive Developmental DisorderJapan
-
Centre for Addiction and Mental HealthCompleted
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)Completed
-
Nova Scotia Health AuthorityCompletedEating DisordersCanada
-
Red Salud Mental ArabaUniversity of the Basque Country (UPV/EHU); University of DeustoUnknown
-
Yale UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanCompleted
-
Vapotherm, Inc.Knox Community Hospital; Riverside Regional Medical Center; Midwest Chest ConsultantsCompleted