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Clinical Trials/NCT03551925
NCT03551925
Completed
Not Applicable

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

University of Indianapolis1 site in 1 country32 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Indianapolis
Enrollment
32
Locations
1
Primary Endpoint
Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
June 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Moore

Assistant Professor, Co-Chair Human Research Protections Program

University of Indianapolis

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.

Outcomes

Primary Outcomes

Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score

Time Frame: The ARMS-7 will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.

The ARMS-7 consists of seven questions that provide a self-report of medication adherence.

Secondary Outcomes

  • Change in Pill count(Pill count will be completed approximately every 4 weeks over a 12 week period by the clinical pharmacist.)
  • 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 Blood pressure(Blood pressure will be taken approximately every 4 weeks over a 12 week period by the clinical pharmacist.)

Study Sites (1)

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