- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06450249
Effects of the Humanitude® Care Methodology on Health Professionals' Perception (Humanitude)
June 4, 2024 updated by: Lille Catholic University
Effects of the Humanitude® Care Methodology on Improving Health Professionals' Perception of Competence and Emotional State
Healthcare professionals providing care for institutionalized older patients must deal with agitated behavior daily.
Such behavior alters the patient's quality of life and generates stress for the caregiver.
Humanitude® Care Methodology is an alternative to pharmaceutical approaches that has demonstrated benefits on care delivery.
The present study aims to investigate the effects of this method on healthcare professionals' perception of competence and emotional state when dealing with difficult care situations.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a retrospective, multicentric, before / after study.
Data collected from a self-administered questionnaire to caregivers working in 32 Continuous Care Units before and after participation in Humanitude® Care Methodology training sessions in the Ile-de-France region in France will be analyzed.
Data on the participants' perception of their own care competence and their emotional state when confronted with several difficult care situations will be collected.
Participants' well-being at work and adhesion to the Humanitude® Care Methodology will be also evaluated.
Study Type
Observational
Enrollment (Actual)
455
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lille, France, 59000
- Groupement des Hôpitaux de l'Institut Catholique de Lille
-
-
Nord
-
Lille, Nord, France, 59000
- GHICL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Professionals trained in the principles and techniques of Humanitude®.
For each training session, these professionals are invited to complete a questionnaire at the beginning and end of the course.
These questionnaires are part of the training organization's quality approach and are designed to assess the impact of the training.
Description
Inclusion Criteria:
- Caregivers taken part in a Humanitude® training course
- Caregivers agreeing to complete pre- and post-training questionnaires
Exclusion Criteria:
- Caregiver not completing the questionnaire at one of the 2 stages of the assessment (before or after)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthcare professionals
Healthcare professionals working in Continuous Care Units before and after participation in Humanitude® Care Methodology (HCM) training sessions in the Ile-de-France region in France
|
During a five-day training session healthcare professionals are trained to the HCM within their own care unit
The self-administered questionnaire will be completed before and after participation in Humanitude® Care Methodology training sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
4-point scale for evaluation of Caregivers' feelings
Time Frame: 5 days
|
Caregivers are asked to comment on their feelings, on a 4-point scale (anxiety; apprehension; serenity; pleasure) when they enter in a resident's room before and after the training.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
4-point scale for evaluation of caregivers'competence
Time Frame: 5 days
|
To collect caregivers' feelings of competence, they are asked to give their opinion on how capable they felt of looking after a resident, on a 4-point scale (not at all capable; not very capable; capable; very capable) when they entered the room of a resident
|
5 days
|
|
3-point scale for evaluation of caregivers' trust in their colleagues
Time Frame: 5 days
|
The degree of trust which caregivers place in their colleagues on a daily basis is assessed on a 3-point scale : no; it's not always up to me; yes).
|
5 days
|
|
Scale for evaluation of caregivers' degree of pleasure in coming to work
Time Frame: 5 days
|
The degree of pleasure in coming to work is assessed on a scale from 0 (not at all) to 10 (a lot).
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie Buttitta, PhD, GHICL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
June 4, 2024
First Submitted That Met QC Criteria
June 4, 2024
First Posted (Actual)
June 10, 2024
Study Record Updates
Last Update Posted (Actual)
June 10, 2024
Last Update Submitted That Met QC Criteria
June 4, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RNIPH-2021-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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