Collecting Pragmatic Data Via Electronic Health Records: ACUAWARE Feasibility and Acceptability Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- University of Utah
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Feasibility metrics - rate of questionnaire completion
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Prior or current diagnosis of:
- •Multiple Sclerosis (MS),
- •any Dementia,
- •Parkinson's Disease,
- •Autism Spectrum Disorder,
- •Pregnancy,
- •Fibromyalgia,
- •Eating Disorder,
- •Down's Syndrome
- •Schizophrenia
Outcomes
Primary Outcomes
Feasibility metrics - rate of questionnaire completion
Time Frame: 24 months
Rate of questionnaire completion by participants (frequency count)
Feasibility metrics - rate of enrollment
Time Frame: 24 months
Rate of enrollment of acupuncturists and patients (frequency count)
Feasibility metrics - rate of retention
Time Frame: 24 months
Rate of retention of acupuncturists and participants (frequency count)
Feasibility metrics - completion rate of acupuncture therapy
Time Frame: 24 months
Rate of completion of acupuncture therapy (AT) (frequency count)
Acceptability metrics
Time Frame: 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 serious adverse events
Time Frame: 24 months
Rate of serious adverse events (frequency count)
Secondary Outcomes
- Global Mental Health(24 months)
- Depression(24 months)
- Irritability(24 months)
- Multidimensional Assessment of Interoceptive Awareness Scale, 2 (MAIA-2)(24 months)
- Global Impression of Change (GIC)(24 months)
- Anxiety(24 months)
- Physical Function from Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)(24 months)