Effect of Occupational Therapy in Promoting Medication Adherence

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabete Type 2
• Intervention / Treatment: Behavioral: Treatment as Usual Plus Occupational Therapy; Behavioral: Treatment as Usual

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:

1. 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.
2. 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
3. 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: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65806
      • Jordan Valley Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

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.	Behavioral: Treatment as Usual Plus Occupational Therapy; 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: IMeds
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.	Behavioral: Treatment as Usual; 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	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.

Collaborators and Investigators

• Sponsor: University of Indianapolis
• Collaborators: University of Missouri, Kansas City; Missouri State University
• Investigators: Principal Investigator: Elizabeth Moore, PhD, University of Indianapolis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: May 26, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 15, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 0901 (Ethikkommision KiKli BE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No