Safety IssuesMIST3NCT04161677
MIST3: Active Patient Safety Reporting
An observational study of Safety Issues, run by Parker University at 1 site in United States.
Trial summary
This study will seek to describe and understand adverse events (AE) severity ratings. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A convenience sample of all patients at the Parker University Wellness clinic will be invited to participate in the study.
Who may be able to join
- Health patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitigation Investigation for Spinal Manipulation Treatments (MIST) - Part 3: Continued Assessment & Feasibility of an Electronic Active Surveillance Reporting System
This study will seek to describe and understand adverse events (AE) severity ratings.
Read the detailed description
Using an explanatory mixed methods design, three different quantitative methods 1. severity ratings based on a series of questions, 2. severity rating based on severity terms, and 3. severity based on definitions will be used to conduct a feasibility study on understanding adverse event reporting system.
- Conditions
- Safety Issues
- Keywords
- Adverse event, Electronic reporting system, Chiropractic, Spinal manipulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-screening questionnaire
Severity rating based on a series of questionnaire
Measured: 5-10 minute
Post-survey
Severity rating based on severity term questionnaire
Measured: Immediately after visit
follow-up questionnaire
Severity rating based on definitions questionnaire
Measured: 7-10 days after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start21 Nov 2019
- Primary completion20 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161677
- Sponsor's protocol ID
- Parker19_05
- Acronym
- MIST3
- Status last verified
- Feb 2021
- First submitted
- 10 Nov 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigation Investigation for Spinal Manipulation Treatments (MIST) - Part 3: Continued Assessment & Feasibility of an Electronic Active Surveillance Reporting System
- ClinicalTrials.gov ID
- NCT04161677
- Acronym / sponsor ID
- MIST3 / Parker19_05
- Conditions
- Safety Issues
- Keywords
- Adverse event, Electronic reporting system, Chiropractic, Spinal manipulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will seek to describe and understand adverse events (AE) severity ratings.
Detailed description
Using an explanatory mixed methods design, three different quantitative methods 1. severity ratings based on a series of questions, 2. severity rating based on severity terms, and 3. severity based on definitions will be used to conduct a feasibility study on understanding adverse event reporting system.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of all patients at the Parker University Wellness clinic will be invited to participate in the study.
Key inclusion criteria (1 listed)
- Health patients
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-screening questionnaire
Time frame: 5-10 minute
Severity rating based on a series of questionnaire
Post-survey
Time frame: Immediately after visit
Severity rating based on severity term questionnaire
follow-up questionnaire
Time frame: 7-10 days after visit
Severity rating based on definitions questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues, run by Parker University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-screening questionnaire (time frame: 5-10 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.