Effect of Occupational Therapy in Promoting Medication Adherence

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551925
• Other study ID #: 0901
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: University of Indianapolis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

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).
• Treatment as Usual
A clinical pharmacist counsels participants on proper medication adherence.

Locations

Country	Name	City	State
United States	Jordan Valley Community Health Center	Springfield	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Indianapolis	Missouri State University, University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.