Patients Receiving Integrative Medicine Interventions Effectiveness Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,069
- 试验地点
- 14
- 主要终点
- PROMIS® CAT
研究概览
简要总结
This registry will perform prospective surveillance of participants attending collaborating Integrative Medicine clinic sites for clinical services. All decisions about medication use, treatments, visit frequency, assessment of tolerance, and other aspects of patient management will be left to the clinical providers' discretion. We will attempt to follow the participants in the PRIMIER Registry for up to 2 years.
Essential data elements that capture patient-reported outcomes and measures of clinical activity will be obtained at approximately 2-month intervals for the first 6 months, then every 6 months through the end of year 2.
详细描述
Rationale:
According to the Agency for Healthcare Research and Quality (AHRQ), observational databases provide an opportunity for simultaneous exploration of the impact of integrative medicine on various medical conditions. As opposed to selecting a single condition for which patients may seek care at our sites, the project will allow us to collect prospective patient-reported outcomes on a number of frequently seen medical conditions. By clustering participants at the multiple IM clinical sites with the same medical condition, we will be able to compare the impact of various integrative therapies on patient-reported outcomes.
Objectives:
Primary Objective
- To evaluate the change in patient-reported outcomes (e.g. quality of life, mood and stress) over time
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be seen as a clinical patient in one of the participating Integrative Medicine (IM) clinics and willing to participate in the Registry
- •Be 18 years of age or older
- •Have access to a computer with internet connection and a valid email address
- •Be willing to be contacted in the future by study investigators
排除标准
- •Not being seen by a provider for clinical purposes, but only involved in an education program or one-time activity
结局指标
主要结局
PROMIS® CAT
时间窗: Baseline, 2, 4, 6 months, then every 6 months through year 2,.
PROMIS® can integrate Item Response Theory (IRT) with computers to administer a PRO instrument. IRT selects questions on the basis of a patient's response to previously administered questions, measurement is "adapted" to individual, skips uninformative items to minimize response burden and allows determination of person's standing on a domain without a loss in measurement precision. The PROMIS® CAT for PRIMIER will be designed to assess anxiety, depression, sleep disturbance, fatigue, pain interference, physical function, and satisfaction with participation in social roles. Questions will be answered electronically using a standard 1-5 Likert scale. Participants will answer between 4 and 12 questions per domain, for a total of 29 to 85 questions.
次要结局
- Patient Activation Measure (PAM)(Baseline, 2, 4, 6 months, then every 6 months through year 2.)
- Perceived Stress Scale - 4(Baseline, 2, 4, 6 months, then every 6 months through year 2.)
- Cost Indicators(Every 6 months)