Covid19CAMPNCT04834583
Corona And Manual Professions
An observational study of Covid19, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This observational study will follow the chiropractors and naprapaths in Sweden to study how work environment, health, and economy is changing during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 703 participants
- Where
- 1 siteSweden
- Study dates
- 2 Nov 2020to 30 Apr 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Manual therapists, clinically active in Sweden
Who may be able to join
- Chiropractor or naprapath working in Sweden
- clinically active
- belonging to a professional organization
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Pandemic and Small Businesses in the Health Care Sector - Work Environment, Health and Economy of Swedish Chiropractors and Naprapaths
This observational study will follow the chiropractors and naprapaths in Sweden to study how work environment, health, and economy is changing during the COVID-19 pandemic.
Read the detailed description
All manual therapists that are members of a professional organization in Sweden will be invited to participate. The study started in November 2020 with follow-ups planned after 3,6 and 12 months.
All data-collection is taking place with digital questionnaires.
There are three main areas of interest:
- Work environment (knowledge about viral contageon, protection, availability of protective measures, disturbances in care for patients)
- Health (physical and psychological, how many caught the virus?)
- Economy (income, costs, turnover)
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Work environment
Changes in routines according to the pandemic This includes systematic work environment routines, cleaning, wearing protective gear, not treating patients belonging to certain risk categories, changing appointment scheduling etc. There are no validated questionnaires to examine these concepts, as we have not experienced a pandemic in modern times, so the questions are constructed by the research group.
Measured: 12 months
Physical Health -Pain
Physical pain using the Nordic Musculoskeletal Questionnaire
Measured: 12 months
Psychological Health -depression
Depression assessed with DASS-21
Measured: 12 months
Psychological Health -sleep
Sleep will be assessed using Karolinska Sleep Questionnaire.
Measured: 12 months
Economy
Changes in company turnover. For clinic owners, this measure is assessing income and cost, estimated by clinic owners, There are no validated questionnaires to examine these concepts, as we have not experienced a pandemic in modern times, so the questions are constructed by the research group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 Nov 2020
- Primary completion31 Jan 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Sophiahemmet University
- Responsible party
- Principal investigator, Iben Axen, Karolinska Institutet
- Investigators
- Iben Axén, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834583
- Sponsor's protocol ID
- KIIMMRIAII
- Acronym
- CAMP
- Status last verified
- Oct 2023
- First submitted
- 31 Mar 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Pandemic and Small Businesses in the Health Care Sector - Work Environment, Health and Economy of Swedish Chiropractors and Naprapaths
- ClinicalTrials.gov ID
- NCT04834583
- Acronym / sponsor ID
- CAMP / KIIMMRIAII
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Sophiahemmet University
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 8 Apr 2021 (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 observational study will follow the chiropractors and naprapaths in Sweden to study how work environment, health, and economy is changing during the COVID-19 pandemic.
Detailed description
All manual therapists that are members of a professional organization in Sweden will be invited to participate. The study started in November 2020 with follow-ups planned after 3,6 and 12 months.
All data-collection is taking place with digital questionnaires.
There are three main areas of interest:
- Work environment (knowledge about viral contageon, protection, availability of protective measures, disturbances in care for patients)
- Health (physical and psychological, how many caught the virus?)
- Economy (income, costs, turnover)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Manual therapists, clinically active in Sweden
Key inclusion criteria (3 listed)
- Chiropractor or naprapath working in Sweden
- clinically active
- belonging to a professional organization
Key exclusion criteria (0 listed)
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
Work environment
Time frame: 12 months
Changes in routines according to the pandemic This includes systematic work environment routines, cleaning, wearing protective gear, not treating patients belonging to certain risk categories, changing appointment scheduling etc. There are no validated questionnaires to examine these concepts, as we have not experienced a pandemic in modern times, so the questions are constructed by the research group.
Physical Health -Pain
Time frame: 12 months
Physical pain using the Nordic Musculoskeletal Questionnaire
Psychological Health -depression
Time frame: 12 months
Depression assessed with DASS-21
Psychological Health -sleep
Time frame: 12 months
Sleep will be assessed using Karolinska Sleep Questionnaire.
Economy
Time frame: 12 months
Changes in company turnover. For clinic owners, this measure is assessing income and cost, estimated by clinic owners, There are no validated questionnaires to examine these concepts, as we have not experienced a pandemic in modern times, so the questions are constructed by the research group.
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 3 Oct 2023.
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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.
Iben Axén principal investigator
Karolinska Institutet
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 Covid19, run by Karolinska Institutet at 1 site in Sweden.
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 3 inclusion and 0 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 3 Oct 2023. 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 Sweden. 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?
Work environment (time frame: 12 months). The study lists 5 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 3 Oct 2023.