Effect of Occupational Therapy in Promoting Medication Adherence

NCT ID: NCT03551925

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-06-01

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:

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.

Conditions

Hypertension; Diabete Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Treatment as Usual Plus Occupational Therapy

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

A clinical pharmacist counsels participants on proper medication adherence.

Interventions

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).

Intervention Type: BEHAVIORAL

Treatment as Usual

A clinical pharmacist counsels participants on proper medication adherence.

Intervention Type: BEHAVIORAL

Other Intervention Names

IMeds

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri, Kansas City

OTHER

Sponsor Role: collaborator

Missouri State University

OTHER

Sponsor Role: collaborator

University of Indianapolis

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Moore

Assistant Professor, Co-Chair Human Research Protections Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Moore, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Indianapolis

Locations

Jordan Valley Community Health Center

Springfield, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29135431 (View on PubMed)

Other Identifiers

0901

Identifier Type: -

Identifier Source: org_study_id