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Acupuncture for Individuals With Stable Angina (AIMS-A)

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ClinicalTrials.gov Identifier: NCT02914834
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Judith Schlaeger, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE August 13, 2016
First Posted Date  ICMJE September 26, 2016
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE January 4, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 1 ]
    The McGill Pain Questionnaire (MPQ) is a well validated and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be. It is a well validated measure of sensory, affective, and evaluative pain.
  • McGill Pain Questionnaire [ Time Frame: after the 10th acupuncture treatment of week 10 ]
    The McGill Pain Questionnaire (MPQ) is a valid and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be. It is a well validated measure of sensory, affective, and evaluative, pain.
  • McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 1 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: before 2nd acupuncture treatment of week 1 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 2 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: before 2nd acupuncture treatment of week 2 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 3 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: before 2nd acupuncture treatment of week 3 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 4 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment of week 4 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 5 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: before 2nd acupuncture treatment of week 5 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 1 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 1 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 2 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 2 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 3 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 3 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 4 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 4 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 5 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 5 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 1 ]
    The McGill Pain Questionnaire (MPQ) is a well validated and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be. It is a well validated measure of sensory, affective, and evaluative pain.
  • McGill Pain Questionnaire [ Time Frame: after the 10th acupuncture treatment of week 10 ]
    The McGill Pain Questionnaire (MPQ) is a valid and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be. It is a well validated measure of sensory, affective, and evaluative, pain.
  • PAINReportIt® [ Time Frame: before 1st acupuncture treatment of week 1 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 2nd acupuncture treatment of week 1 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 1st acupuncture treatment of week 2 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 2nd acupuncture treatment of week 2 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 1st acupuncture treatment of week 3 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 2nd acupuncture treatment of week 3 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 1st acupuncture treatment of week 4 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 2nd acupuncture treatment of week 4 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 1st acupuncture treatment of week 5 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 2nd acupuncture treatment of week 5 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 1st acupuncture treatment week 1 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 2nd acupuncture treatment week 1 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 1st acupuncture treatment week 2 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 2nd acupuncture treatment week 2 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 1st acupuncture treatment week 3 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 2nd acupuncture treatment week 3 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 1st acupuncture treatment week 4 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 2nd acupuncture treatment week 4 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 1st acupuncture treatment week 5 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: after 2nd acupuncture treatment week 5 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
Change History Complete list of historical versions of study NCT02914834 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • Seattle Angina Questionnaire-7 (SAQ-7) [ Time Frame: Before first acupuncture treatment of week one ]
    The instrument consists of 7 items in 5 domains (Physical Limitation, Angina Stability, Angina Frequency, and Quality of Life) measuring the impact of angina on participants' health status. Item responses are coded sequentially from worst to best status and range from 1 to 6 except Quality of Life (range 1-5). Scores are generated for each domain and are scaled 0 to 100, with 0 denoting the worst and 100 the best possible status.
  • Seattle Angina Questionnaire-7 (SAQ-7) [ Time Frame: after the 2nd acupuncture treatment of week 5 ]
    The instrument consists of 7 items in 5 domains (Physical Limitation, Angina Stability,
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 22, 2018)
  • My Angina Log, American Heart Association [ Time Frame: completed with each event of angina symptoms from date of randomization to 5 weeks (study completion) ]
    My angina log is a self-report log of angina symptoms to be completed when angina symptoms occur. It is a record of when angina occurs, what initiated and relieved the symptoms.
  • Inflammatory biomarkers blood test [ Time Frame: from date of randomization to 5 weeks (study completion) ]
    Inflammatory biomarkers between the acupuncture and control group (IL-1β, IL- 2, IL-6, IL1B, IL-2, IL-6, IL-8, IL-10, and IL-18; CRP, TNF-α)
Original Other Pre-specified Outcome Measures
 (submitted: September 23, 2016)
My Angina Log, American Heart Association [ Time Frame: completed with each event of angina symptoms from date of randomization to 5 weeks (study completion) ]
My angina log is a self-report log of angina symptoms to be completed when angina symptoms occur. It is a record of when angina occurs, what initiated and relieved the symptoms.
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Individuals With Stable Angina
Official Title  ICMJE Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)
Brief Summary This RCT aims to determine if it is possible to perform acupuncture on men and women diagnosed with stable angina who have symptoms. The investigators want to determine if acupuncture reduces the pain and other symptoms of angina. The investigators also want to examine whether this study is acceptable to the participants, and by carrying out this study the investigators will be able to tell how many participants they will need in a future larger study to further test acupuncture to reduce the symptoms of angina in women.
Detailed Description The investigators are conducting a RCT aimed at gathering feasibility, and initial efficacy for a randomized controlled trial (RCT) to test the effect of acupuncture on anginal symptoms in men and women. The investigators long term goal is pain and symptom management resulting in improved functional status and quality of life for men and women with stable angina. This study will include 69 community dwelling men and women with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been completely controlled with guideline-directed medical management. The investigators will use a randomized attention control design with 13 men and women assigned to initial acupuncture and 13 to control. Participants in the experimental group will receive a standardized acupuncture point prescription two treatments per week, for 5 weeks. The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Angina, Stable
Intervention  ICMJE
  • Other: Acupuncture
    Standardized acupuncture treatment administered for 30 minutes each session
  • Other: Non-pain related video health education
    Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
Study Arms  ICMJE
  • Experimental: Device Acupuncture
    Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
    Intervention: Other: Acupuncture
  • Active Comparator: Non-pain related video health education
    The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.
    Intervention: Other: Non-pain related video health education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2016)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • provision of a verified diagnosis from a care provider
  • male or female sex
  • at least 21 years of age
  • intermittent angina symptoms (pain, pressure, or discomfort in the chest or other areas of the upper body)
  • medical confirmation of a diagnosis of stable angina for at least 6 months

Exclusion criteria:

  • pregnancy
  • heart failure
  • COPD causing pain or associated symptoms
  • autoimmune dysfunction
  • use of steroid medications
  • concomitant physical therapy
  • biofeedback
  • massage
  • additional acupuncture
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Holli A DeVon, PhD (312) 413-5362 hdevon1@uic.edu
Contact: Judith M Schlaeger, PhD (312) 413-4669 jschlaeg@uic.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02914834
Other Study ID Numbers  ICMJE 2016-0642
R21NR017705-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: One year after study completion deidentified data will be completed.
Responsible Party Judith Schlaeger, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Holli A DeVon, PhD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP