Effect of Occupational Therapy in Promoting Medication Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Occupational Therapy in Promoting Medication Adherence: A Randomized Control Trial

Conditions
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Hypertension, Diabete Type 2

Intervention / Treatment
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* Behavioral: Treatment as Usual Plus Occupational Therapy
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment as Usual Plus Occupational Therapy<br>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. | Behavioral: Treatment as Usual Plus Occupational Therapy<br>* 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).<br>* Other names: IMeds;|
| Active Comparator: Treatment as Usual (TAU)<br>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. | Behavioral: Treatment as Usual<br>* A clinical pharmacist counsels participants on proper medication adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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. |