Clinical trial NCT03551925: Effect of Occupational Therapy in Promoting Medication Adherence
Official title: Effect of Occupational Therapy in Promoting Medication Adherence: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabete Type 2
Lead sponsor: University of Indianapolis
Sponsor class: OTHER
Collaborators: name: University of Missouri, Kansas City
name: Missouri State University
First posted: 2018-06-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score
timeFrame: The ARMS-7 will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.
Secondary outcomes:
measure: Change in Stages of Change Measure Score
timeFrame: The stages of change measure will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.
measure: Change in Pill count
timeFrame: Pill count will be completed approximately every 4 weeks over a 12 week period by the clinical pharmacist.
measure: Change in Blood pressure
timeFrame: Blood pressure will be taken approximately every 4 weeks over a 12 week period by the clinical pharmacist.
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Jordan Valley Community Health Center
state: Missouri
Study officials:
affiliation: University of Indianapolis
name: Elizabeth Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.