SARS-CoV InfectionNCT04739449
'4C' Intervention to Reduce SARS-CoV-2 (Covid-19) Transmission
A study testing Coaching, Cleaning, Communication, Collaboration in people with SARS-CoV Infection and Covid19, run by University of Michigan.
Trial summary
Nursing homes have long faced special challenges in implementing effective infection prevention programs, including limited resources and diagnostic challenges in a frail functionally disabled long-stay population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection, Covid19
- What is being tested?
- Coaching, Cleaning, Communication, Collaboration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2021to Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Residing in a participating nursing home facility
- Active or recent (last 14 days) COVID-19 infection
- Healthcare worker at a participating nursing home facility
Who cannot join
- Not located in a participating nursing home facility
- None
About this study
Official title: '4C' Intervention to Reduce SARS-CoV-2 Transmission: Coaching, Cleaning, Communication and Collaboration
Nursing homes have long faced special challenges in implementing effective infection prevention programs, including limited resources and diagnostic challenges in a frail functionally disabled long-stay population. Advancing our understanding of the transmission of SARS-CoV-2 within these facilities for vulnerable populations deserves urgent and further investigation. Environmental contamination with SARS-CoV-2 that is reported in limited studies highlights the potential importance of transmission between patients, their environment, and healthcare providers via direct and indirect contact.
This study seeks to characterize the epidemiology of SARS-CoV- 2 in the NH patient room environment over time and the risk of transmission to near and far environments, with the explicit intent of developing integrated, simple COVID-19 infection prevention strategies that can be reported to and implemented throughout other nursing homes and long-term care facilities.
Read the detailed description
In order to achieve these goals the study is being performed at four different nursing homes and will include patients with active or with recent COVID-19 infection, as well as nursing home staff members. The study will test a multimodal aging-friendly intervention including four components and hypothesizes that the implementation of this organizational, educational, quality improvement program will be associated with lower odds of SARS-CoV-2 transmission to the environment.
- Conditions
- SARS-CoV Infection, Covid19
- Being tested
- Coaching, Cleaning, Communication, Collaboration
- Keywords
- Environmental Contamination, Nursing Home, Interventions
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching, Cleaning, Communication, CollaborationBehavioural
- Coaching staff
- Cleaning protocols, standardized
- Communication with staff and leadership
- Collaboration with local expertise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Two facilities will follow their local protocols for infection prevention, including COVID-19 precautions. We will swab environmental surfaces at these sites to compare outcomes. |
| Intervention | Experimental | Using a cluster-randomized design, we will test a multimodal aging-friendly intervention including four components (4Cs):
1. Coaching staff
2. Cleaning protocols, standardized
3. Communication with staff and leadership
4. Collaboration with local expertise
We hypothesize that the implementation of this organizational QI educational program will be associated with lower odds of SARS-CoV-2 transmission to the environment. Receives: Behavioral: Coaching, Cleaning, Communication, Collaboration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface contamination with SARS-CoV-2
Prevalence of SARS-CoV-2 on surfaces in COVID-19 positive patient rooms
Measured: 3 months, depending on COVID-19 epidemiology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start4 Dec 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: Since the vaccine there are no COVID 19 cases in proposed study sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will have a cluster-randomized design in which two of the four nursing homes will be randomized to the intervention arm or the control arm.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lona Mody, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739449
- Sponsor's protocol ID
- HUM00186126
- Other IDs
- 3P30AG024824-16S1
- Status last verified
- Nov 2021
- First submitted
- 3 Feb 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- '4C' Intervention to Reduce SARS-CoV-2 Transmission: Coaching, Cleaning, Communication and Collaboration
- ClinicalTrials.gov ID
- NCT04739449
- Acronym / sponsor ID
- HUM00186126
- Conditions
- SARS-CoV Infection, Covid19
- Keywords
- Environmental Contamination, Nursing Home, Interventions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Since the vaccine there are no COVID 19 cases in proposed study sites.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Dec 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 4 Feb 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.
Nursing homes have long faced special challenges in implementing effective infection prevention programs, including limited resources and diagnostic challenges in a frail functionally disabled long-stay population. Advancing our understanding of the transmission of SARS-CoV-2 within these facilities for vulnerable populations deserves urgent and further investigation. Environmental contamination with SARS-CoV-2 that is reported in limited studies highlights the potential importance of transmission between patients, their environment, and healthcare providers via direct and indirect contact.
This study seeks to characterize the epidemiology of SARS-CoV- 2 in the NH patient room environment over time and the risk of transmission to near and far environments, with the explicit intent of developing integrated, simple COVID-19 infection prevention strategies that can be reported to and implemented throughout other nursing homes and long-term care facilities.
Detailed description
In order to achieve these goals the study is being performed at four different nursing homes and will include patients with active or with recent COVID-19 infection, as well as nursing home staff members. The study will test a multimodal aging-friendly intervention including four components and hypothesizes that the implementation of this organizational, educational, quality improvement program will be associated with lower odds of SARS-CoV-2 transmission to the environment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will have a cluster-randomized design in which two of the four nursing homes will be randomized to the intervention arm or the control arm.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Two facilities will follow their local protocols for infection prevention, including COVID-19 precautions. We will swab environmental surfaces at these sites to compare outcomes. |
| Intervention | Experimental | Behavioral: Coaching, Cleaning, Communication, CollaborationUsing a cluster-randomized design, we will test a multimodal aging-friendly intervention including four components (4Cs): 1. Coaching staff 2. Cleaning protocols, standardized 3. Communication with staff and leadership 4. Collaboration with local expertise We hypothesize that the implementation of this organizational QI educational program will be associated with lower odds of SARS-CoV-2 transmission to the environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Residing in a participating nursing home facility
- Active or recent (last 14 days) COVID-19 infection
- Healthcare worker at a participating nursing home facility
Key exclusion criteria (2 listed)
- Not located in a participating nursing home facility
- 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 |
|---|---|---|
| Coaching, Cleaning, Communication, Collaboration1. Coaching staff 2. Cleaning protocols, standardized 3. Communication with staff and leadership 4. Collaboration with local expertise | Behavioural | Intervention |
Primary outcome
Surface contamination with SARS-CoV-2
Time frame: 3 months, depending on COVID-19 epidemiology
Prevalence of SARS-CoV-2 on surfaces in COVID-19 positive patient rooms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching, Cleaning, Communication, Collaboration in people with SARS-CoV Infection and Covid19, run by University of Michigan.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Surface contamination with SARS-CoV-2 (time frame: 3 months, depending on COVID-19 epidemiology). 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 19 Nov 2021.