Collecting Pragmatic Data Via Electronic Health Records: ACUAWARE Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Feasibility metrics - rate of enrollment
研究概览
简要总结
This study aims to gather preliminary feasibility and acceptability data to justify a subsequent trial that would fill a gap in knowledge regarding acupuncture therapy (AT) effects on interoceptive awareness (IA) among those with chronic pain.
详细描述
This study aims to gather preliminary feasibility and acceptability data to justify a subsequent trial that would fill a gap in knowledge regarding acupuncture's effects on interoceptive awareness among individuals with chronic pain. Our primary hypotheses are that (1) Feasibility: it is feasible for us to enroll and retain 70% of the patients and it is feasible to collect data from at least 70% of participants at 3-months follow-up, and (2) Acceptability: it is acceptable for 70% of licensed acupuncturists to use Acu-Track Registry; it is acceptable for 70% of patients to complete questionnaires emailed to them via Acu-Track Registry.
The investigators propose to evaluate these hypotheses by conducting a prospective, pragmatic single-arm feasibility and acceptability study among individuals with chronic pain of any etiology or location, except if due to cancer. Chronic pain is defined as pain that persists or recurs for more than 3 months.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older;
- •experiencing chronic pain,
- •complaint of 3+ months,
- •score of 5 or greater on a 1-10 scale;
- •able to provide informed consent
- •willing to sign an approved consent form that conforms to federal and institutional guidelines,
- •English speaking and writing.
排除标准
- •Prior or current diagnosis of:
- •Multiple Sclerosis (MS),
- •any Dementia,
- •Parkinson's Disease,
- •Autism Spectrum Disorder,
- •Pregnancy,
- •Fibromyalgia,
- •Eating Disorder,
- •Down's Syndrome
- •Schizophrenia
结局指标
主要结局
Feasibility metrics - rate of enrollment
时间窗: 24 months
Rate of enrollment of acupuncturists and patients (frequency count)
Feasibility metrics - rate of retention
时间窗: 24 months
Rate of retention of acupuncturists and participants (frequency count)
Feasibility metrics - completion rate of acupuncture therapy
时间窗: 24 months
Rate of completion of acupuncture therapy (AT) (frequency count)
Acceptability metrics
时间窗: 24 months
Acceptability ratings by licensed acupuncturists and by participants. Acceptability is asked in a binary question: "Is it acceptable to you to use the Acu-Track registry?" Yes/No. We define "acceptable" as 70% or more of licensed acupuncturists to use Acu-Track Registry; and acceptable for 70% or more of patients to complete questionnaires emailed to them via Acu-Track Registry.
Feasibility metrics - rate of questionnaire completion
时间窗: 24 months
Rate of questionnaire completion by participants (frequency count)
Feasibility metrics - rate of serious adverse events
时间窗: 24 months
Rate of serious adverse events (frequency count)
次要结局
- Irritability(24 months)
- Global Impression of Change (GIC)(24 months)
- Global Mental Health(24 months)
- Depression(24 months)
- Multidimensional Assessment of Interoceptive Awareness Scale, 2 (MAIA-2)(24 months)
- Anxiety(24 months)
- Physical Function from Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)(24 months)