Effect of Occupational Therapy in Promoting Medication Adherence: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment as Usual Plus Occupational Therapy
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.
干预措施: Treatment as Usual Plus Occupational Therapy (Behavioral)
Treatment as Usual (TAU)
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.
干预措施: Treatment as Usual (Behavioral)
结局指标
主要结局
Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score
时间窗: 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.
次要结局
- 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.)
研究者
Elizabeth Moore
Assistant Professor, Co-Chair Human Research Protections Program
University of Indianapolis