Diabetes ScreeningNCT02418637
Pilot Study Testing Feasibility of Health Screening at Farm Site
A study testing Worksite screening for DM, HTN and hyperlipidemia in people with Diabetes Screening and Hyperlipidemia Screening, run by Mayo Clinic at 1 site in United States.
Trial summary
Test the feasibility of performing worksite screening of Hypertension, Diabetes and Hyperlipidemia for six months Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Screening, Hyperlipidemia Screening, Hypertension Screening
- What is being tested?
- Worksite screening for DM, HTN and hyperlipidemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- agricultural workers and farm owners
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Worksite Screening for Cardiovascular Risk Factors Among Migrant Agricultural Workers
Test the feasibility of performing worksite screening of Hypertension, Diabetes and Hyperlipidemia for six months
Read the detailed description
The investigators will be visiting farmers at the worksite monthly for six month and perform cardiovascular risk factors screening: blood pressure, blood glucose, glycosylated hemoglobin and cholesterol.
At the end of this intervention, the investigators will test the feasibility of this approach among this specific population through questionnaires.
- Being tested
- Worksite screening for DM, HTN and hyperlipidemia
- Keywords
- worksite, screen, migrant, agricultural, worker, hypertension, Hyperlipidemia, diabetes, feasibility
- Medical subject headings
- Hypertension, Hyperlipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Worksite screening for DM, HTN and hyperlipidemiaOther
Six monthly visits to worksite to perform screenings
| Study group | Role | What they receive |
|---|---|---|
| Farm workers | Experimental | This is a one arm intervention including farm workers and owners Receives: Other: Worksite screening for DM, HTN and hyperlipidemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Likert scale)
On a likert scale, the investigators will test the applicability, acceptance and convenience of this screening approach among this agricultural workers population
Measured: After six months of the intervention, the outcome will be assessed on the last site visit via questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes ScreeningStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Hassan Murad, M.D., Mayo Clinic
- Investigators
- M Murad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418637
- Sponsor's protocol ID
- 15-000647
- Status last verified
- Nov 2016
- First submitted
- 6 Apr 2015
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rajjo T, Mohammed K, Rho J, Murad MH. On-the-farm cardiovascular risk screening among migrant agricultural workers in Southeast Minnesota: a pilot prospective study. BMJ Open. 2018 Jul 30;8(7):e019547. doi: 10.1136/bmjopen-2017-019547.
PubMed 30061429
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worksite Screening for Cardiovascular Risk Factors Among Migrant Agricultural Workers
- ClinicalTrials.gov ID
- NCT02418637
- Acronym / sponsor ID
- 15-000647
- Keywords
- worksite, screen, migrant, agricultural, worker, hypertension, Hyperlipidemia, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Apr 2015 (estimated)
- 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.
Test the feasibility of performing worksite screening of Hypertension, Diabetes and Hyperlipidemia for six months
Detailed description
The investigators will be visiting farmers at the worksite monthly for six month and perform cardiovascular risk factors screening: blood pressure, blood glucose, glycosylated hemoglobin and cholesterol.
At the end of this intervention, the investigators will test the feasibility of this approach among this specific population through questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Farm workers | Experimental | Other: Worksite screening for DM, HTN and hyperlipidemiaThis is a one arm intervention including farm workers and owners |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- agricultural workers and farm owners
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Worksite screening for DM, HTN and hyperlipidemiaSix monthly visits to worksite to perform screenings | Other | Farm workers |
Primary outcome
Feasibility (Likert scale)
Time frame: After six months of the intervention, the outcome will be assessed on the last site visit via questionnaire
On a likert scale, the investigators will test the applicability, acceptance and convenience of this screening approach among this agricultural workers population
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 9 Nov 2016.
- Derived from this study: PubMed 30061429Rajjo T, Mohammed K, Rho J, Murad MH. On-the-farm cardiovascular risk screening among migrant agricultural workers in Southeast Minnesota: a pilot prospective study. BMJ Open. 2018 Jul 30;8(7):e019547. doi: 10.1136/bmjopen-2017-019547.
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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.
M Murad, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Worksite screening for DM, HTN and hyperlipidemia in people with Diabetes Screening and Hyperlipidemia Screening, run by Mayo Clinic 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 2 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 9 Nov 2016. 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?
Feasibility (Likert scale) (time frame: After six months of the intervention, the outcome will be assessed on the last site visit via questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02418637, which also lists 1 linked publication.
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 9 Nov 2016.