Effect of Occupational Therapy in Promoting Medication Adherence
Primary Purpose
Hypertension, Diabete Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment as Usual Plus Occupational Therapy
Treatment as Usual
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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.
Sites / Locations
- Jordan Valley Community Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment as Usual Plus Occupational Therapy
Treatment as Usual (TAU)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score
The ARMS-7 consists of seven questions that provide a self-report of medication adherence.
Secondary Outcome Measures
Change in Stages of Change Measure Score
A single-item multiple choice question that assesses an individuals current readiness for change.
Change in Pill count
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.
Change in Blood pressure
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.
Full Information
NCT ID
NCT03551925
First Posted
May 26, 2018
Last Updated
June 15, 2019
Sponsor
University of Indianapolis
Collaborators
University of Missouri, Kansas City, Missouri State University
1. Study Identification
Unique Protocol Identification Number
NCT03551925
Brief Title
Effect of Occupational Therapy in Promoting Medication Adherence
Official Title
Effect of Occupational Therapy in Promoting Medication Adherence: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Indianapolis
Collaborators
University of Missouri, Kansas City, Missouri State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to see if an occupational therapist can help people with high blood pressure and/or diabetes find ways to better take their medicine. Participants will be recruited from the Jordan Valley Community Health Center in Springfield, Missouri.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabete Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized controlled trial using a pretest-posttest control group design to allow for comparison between a treatment as usual (TAU) group supporting medication adherence and a TAU group that receives an additional occupational therapy intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual Plus Occupational Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual Plus Occupational Therapy
Other Intervention Name(s)
IMeds
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
A clinical pharmacist counsels participants on proper medication adherence.
Primary Outcome Measure Information:
Title
Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score
Description
The ARMS-7 consists of seven questions that provide a self-report of medication adherence.
Time Frame
The ARMS-7 will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.
Secondary Outcome Measure Information:
Title
Change in Stages of Change Measure Score
Description
A single-item multiple choice question that assesses an individuals current readiness for change.
Time Frame
The stages of change measure will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.
Title
Change in Pill count
Description
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.
Time Frame
Pill count will be completed approximately every 4 weeks over a 12 week period by the clinical pharmacist.
Title
Change in Blood pressure
Description
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.
Time Frame
Blood pressure will be taken approximately every 4 weeks over a 12 week period by the clinical pharmacist.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Moore, PhD
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan Valley Community Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65806
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29135431
Citation
Schwartz JK, Grogan KA, Mutch MJ, Nowicki EB, Seidel EA, Woelfel SA, Smith RO. Intervention to Improve Medication Management: Qualitative Outcomes From a Phase I Randomized Controlled Trial. Am J Occup Ther. 2017 Nov/Dec;71(6):7106240010p1-7106240010p10. doi: 10.5014/ajot.2017.021691.
Results Reference
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Effect of Occupational Therapy in Promoting Medication Adherence
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