FoCo: Evaluating a Training to Increase Attention and Awa... | NCT04362397

Studies
FoCo: Evaluating a Training to Increase Attention and Awareness of Healthcare Professionals

NCT04362397

Sponsor

Hospital Israelita Albert Einstein

Status

Completed

Last Update Posted

Feb 11, 2021Actual

Enrollment

190Actual

Phase

Not Applicable

Conditions

Attention
Self-compassion

Interventions

FoCo
No intervention

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2019Actual

Primary Completion Date

May 20, 2020Actual

Completion Date

Dec 20, 2020Actual

First Submitted Date

Dec 19, 2019

First Submission Date that Met QC Criteria

Apr 22, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2021

Last Update Posted Date

Feb 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A (first group to receive the intervention)	Experimental	This arm will receive the attention, care, and self-care training first.	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.	Behavioral: FoCo Behavioral: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FoCo	Behavioral	This is an attention, care and self-care training.	A (first group to receive the intervention) B (second group to receive the intervention)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in stress	The authors will evaluate attention using the MAAS (Mindful Attention Awareness Scale).	1 month
change in attention	The authors will apply the Perceived Stress Scale	1 month

Secondary Outcomes

Measure	Description	Time Frame
change in self-compassion	The authorswill apply the self-compassion scale	1 month
change in sleep	The authors will apply the Pittsburgh inventory

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be available to participate in the training and to perform the evaluations before and after it.

Exclusion Criteria:

- being away or on vacation during the research project, being in psychiatric treatment.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elisa H Kozasa, PhD	Hospital Israelita Albert Einstein	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Israelita Albert Einstein		São Paulo		05652901	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention 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.