NCT03412110

Brief Summary

This study aims to compare different ways to establish severity from patients reporting a new or worsening symptom (adverse event) following a chiropractic treatment at a teaching clinic using an electronic platform.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 17, 2018

Last Update Submit

January 13, 2020

Conditions

Patient SafetyManipulation, Spinal

Keywords

chiropracticSMTActive surveillance reporting system

Outcome Measures

Primary Outcomes (2)

  • patient - report of an adverse event

    as any unfavorable sign, symptom or disease temporarily associated with the treatment, whether or not caused by the treatment, specifically any worsened or new symptom reported by the patient up to one week after care

    Up to 7 days post treatment - Day 0-7

  • intern - report of an adverse event

    as any unfavorable sign, symptom or disease temporarily associated with the treatment, whether or not caused by the treatment, specifically any worsened or new symptom reported by the intern immediately following care

    Immediate after treatment - Day 0

Interventions

active surveillance: electronic platformOTHER

Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Each supervising faculty clinician in the Parker Wellness Clinic had data collected from interested patients during a pre-specified one week period of time.

You may qualify if:

  • Patients at the Parker University Wellness Clinic
  • Agreed to participate

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parker University

Dallas, Texas, 75229, United States

Location

Study Officials

  • Katherine A Pohlman, DC, MS

    Parker University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 26, 2018

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

US(1)