AttentionFoCoNCT04362397
FoCo: Evaluating a Training to Increase Attention and Awareness of Healthcare Professionals
A study testing FoCo in people with Attention and Self-compassion, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Introduction: A significant increase in the risk of injury and illness at work has been associated with fatigue, stress, haste, distraction, emergency situations, excessive noise, complex procedures and anger among other factors. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention, Self-compassion
- What is being tested?
- FoCo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2019to 20 Dec 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be available to participate in the training and to perform the evaluations before and after it.
Who cannot join
- being away or on vacation during the research project, being in psychiatric treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Foco: Evaluating a Training to Increase Attention and Awareness in the Daily Activities of Healthcare Professionals
Introduction: A significant increase in the risk of injury and illness at work has been associated with fatigue, stress, haste, distraction, emergency situations, excessive noise, complex procedures and anger among other factors.
Most of these factors are related to the lack of attention to work in progress, which can be improved by training attention and awareness during daily activities, as it would encourage a resumption of focus on the task at hand and the possible risks associated with it. . The primary objective of this project is to evaluate the effects of training to increase attention and awareness for daily activities - FoCo - outlined for healthcare professionals in their work schedule. Method: Health professionals from 18 to 60 years of age, of both sexes, will participate in the study, working in 3 units, one in the care of patients in a Emergency Care Unit (UPA), in an Elderly Residential and in a Center. Intensive Care (ICU). In the UPA will be included 25 professionals in group A and 25 in group B; In the Residential of Elderly, 40 professionals will be included in group A and 40 professionals in group B; In the ICU will be included 30 professionals in group A and 30 in group B. They will be randomized in both groups. Group A will receive training in the FoCo program and group B will be a waiting group. After a period of one month, group B will receive training in FoCo and group A will be instructed to continue on their own to apply FoCo in their daily lives (Fig.1). Participants will be evaluated before, after one month and after two months. Expected Outcomes: After training, an increase in mindful, attention and awareness scale, self-compassion scale, positive affect, speed of digit and symbol test is expected. It is also expected to reduce negative affects, perceived stress and an increased perception of possible incidents.
- Conditions
- Attention, Self-compassion
- Being tested
- FoCo, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoCoBehavioural
This is an attention, care and self-care training.
No interventionBehavioural
This is a waiting list
| Study group | Role | What they receive |
|---|---|---|
| A (first group to receive the intervention) | Experimental | This arm will receive the attention, care, and self-care training first. Receives: Behavioral: FoCo; Behavioral: No intervention |
| B (second group to receive the intervention) | Experimental | This arm will not receive intervention in the first month and will receive it after this period. Receives: Behavioral: FoCo; Behavioral: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in stress
The authors will evaluate attention using the MAAS (Mindful Attention Awareness Scale).
Measured: 1 month
change in attention
The authors will apply the Perceived Stress Scale
Measured: 1 month
Secondary outcomes (4)
change in self-compassion
The authorswill apply the self-compassion scale
Measured: 1 month
change in sleep
The authors will apply the Pittsburgh inventory
Measured: 1 month
change in Mental health symptoms
The authors will apply the SRQ-20 (self-report questionnaire)
Measured: 1 month
change in positive and negative affect
The authors will apply PANAS
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Aug 2019
- Primary completion20 May 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttentionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Group A will receive training in the FoCo program and group B will be a waiting list group. After a period of one month, group B will receive training in FoCo and group A will be instructed to continue on their own to apply FoCo in their daily lives.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa H Kozasa, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362397
- Sponsor's protocol ID
- HIAE_FoCo
- Acronym
- FoCo
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foco: Evaluating a Training to Increase Attention and Awareness in the Daily Activities of Healthcare Professionals
- ClinicalTrials.gov ID
- NCT04362397
- Acronym / sponsor ID
- FoCo / HIAE_FoCo
- Conditions
- Attention, Self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 24 Apr 2020 (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.
Introduction: A significant increase in the risk of injury and illness at work has been associated with fatigue, stress, haste, distraction, emergency situations, excessive noise, complex procedures and anger among other factors.
Most of these factors are related to the lack of attention to work in progress, which can be improved by training attention and awareness during daily activities, as it would encourage a resumption of focus on the task at hand and the possible risks associated with it. . The primary objective of this project is to evaluate the effects of training to increase attention and awareness for daily activities - FoCo - outlined for healthcare professionals in their work schedule. Method: Health professionals from 18 to 60 years of age, of both sexes, will participate in the study, working in 3 units, one in the care of patients in a Emergency Care Unit (UPA), in an Elderly Residential and in a Center. Intensive Care (ICU). In the UPA will be included 25 professionals in group A and 25 in group B; In the Residential of Elderly, 40 professionals will be included in group A and 40 professionals in group B; In the ICU will be included 30 professionals in group A and 30 in group B. They will be randomized in both groups. Group A will receive training in the FoCo program and group B will be a waiting group. After a period of one month, group B will receive training in FoCo and group A will be instructed to continue on their own to apply FoCo in their daily lives (Fig.1). Participants will be evaluated before, after one month and after two months. Expected Outcomes: After training, an increase in mindful, attention and awareness scale, self-compassion scale, positive affect, speed of digit and symbol test is expected. It is also expected to reduce negative affects, perceived stress and an increased perception of possible incidents.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A will receive training in the FoCo program and group B will be a waiting list group. After a period of one month, group B will receive training in FoCo and group A will be instructed to continue on their own to apply FoCo in their daily lives.
| Arm | Type | Receives |
|---|---|---|
| A (first group to receive the intervention) | Experimental | Behavioral: FoCo, Behavioral: No interventionThis arm will receive the attention, care, and self-care training first. |
| B (second group to receive the intervention) | Experimental | Behavioral: FoCo, Behavioral: No interventionThis arm will not receive intervention in the first month and will receive it after this period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- be available to participate in the training and to perform the evaluations before and after it.
Key exclusion criteria (1 listed)
- being away or on vacation during the research project, being in psychiatric treatment.
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 |
|---|---|---|
| FoCoThis is an attention, care and self-care training. | Behavioural | A (first group to receive the intervention), B (second group to receive the intervention) |
| No interventionThis is a waiting list | Behavioural | A (first group to receive the intervention), B (second group to receive the intervention) |
Primary outcome
change in stress
Time frame: 1 month
The authors will evaluate attention using the MAAS (Mindful Attention Awareness Scale).
change in attention
Time frame: 1 month
The authors will apply the Perceived Stress Scale
4 secondary outcomes
change in self-compassion
Time frame: 1 month
change in sleep
Time frame: 1 month
change in Mental health symptoms
Time frame: 1 month
change in positive and negative affect
Time frame: 1 month
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 11 Feb 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.
Elisa H Kozasa, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoCo in people with Attention and Self-compassion, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 11 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 Brazil. 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?
change in stress (time frame: 1 month). The study lists 2 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 11 Feb 2021.