Diabete Type 2, Hypertension
Conditions
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.
Interventions
BEHAVIORALTreatment 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).
BEHAVIORALTreatment as Usual
A clinical pharmacist counsels participants on proper medication adherence.
Sponsors
University of Missouri, Kansas City
Missouri State University
University of Indianapolis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | A single-item multiple choice question that assesses an individuals current readiness for change. |
| Change in Pill count | Pill count will be completed approximately every 4 weeks over a 12 week period by the clinical pharmacist. | 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. |
| Change in Blood pressure | Blood pressure will be taken approximately every 4 weeks over a 12 week period by the clinical pharmacist. | 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. |
Countries
United States
Outcome results
None listed