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| Name | Class |
|---|---|
| University of Missouri, Kansas City | OTHER |
| Missouri State University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual Plus Occupational Therapy | Experimental | 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. |
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| Treatment as Usual (TAU) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as Usual Plus Occupational Therapy | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Change in Pill count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Moore, PhD | University of Indianapolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan Valley Community Health Center | Springfield | Missouri | 65806 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29135431 | Background | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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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.
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| Treatment as Usual | Behavioral | A clinical pharmacist counsels participants on proper medication adherence. |
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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. |
| 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. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |