Effect of Occupational Therapy in Promoting Medication Adherence

NCT03551925 | Completed

• 1 other identifier: 0901
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabete Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Stages of Change Measure Score

  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

  Pill count will be completed approximately every 4 weeks over a 12 week period by the clinical pharmacist.

• Change in Blood pressure

  Blood pressure will be taken approximately every 4 weeks over a 12 week period by the clinical pharmacist.

Study Arms (2)

Treatment as Usual Plus Occupational Therapy

EXPERIMENTAL

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Interventions

Treatment as Usual Plus Occupational Therapy BEHAVIORAL

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).

Also known as: IMeds

Treatment as Usual Plus Occupational Therapy

Treatment as Usual BEHAVIORAL

A clinical pharmacist counsels participants on proper medication adherence.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Indianapolis: lead
• University of Missouri, Kansas City: collaborator
• Missouri State University: collaborator

Study Sites (1)

Jordan Valley Community Health Center

Springfield, Missouri, 65806, United States

Location

Related Publications (1)

• 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.

  PMID: 29135431 BACKGROUND

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

Therapeutics; Occupational Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Elizabeth Moore, PhD

  University of Indianapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Co-Chair Human Research Protections Program

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 11, 2018
• Study Start: July 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)