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CompletedNCT06450249HumanitudeUpdated Jun 10, 2024

Effects of the Humanitude® Care Methodology on Health Professionals' Perception

An observational study in Delivery of Health Care, Education, Medical and Caregiver, sponsored by Lille Catholic University. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-10.

Sponsored by Lille Catholic University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
455
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Delivery of Health Care
  • Education, Medical
  • Caregiver

Keywords

  • Humanitude
  • Care methodology
  • Agitated behavior
  • Quality of care
  • Health professional
  • Well being
  • Medical education
03

In context

Lead sponsor

Lille Catholic University is the lead sponsor of 111 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

  • Caregivers taken part in a Humanitude® training course
  • Caregivers agreeing to complete pre- and post-training questionnaires

Exclusion criteria

Exclusion Criteria:

  • Caregiver not completing the questionnaire at one of the 2 stages of the assessment (before or after)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
455 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Behavioral: Humanitude® Care Methodology (HCM) training sessions · Behavioral: Self-administered questionnaire

Interventions

  • BehavioralHumanitude® Care Methodology (HCM) training sessions

    During a five-day training session healthcare professionals are trained to the HCM within their own care unit

  • BehavioralSelf-administered questionnaire

    The self-administered questionnaire will be completed before and after participation in Humanitude® Care Methodology training sessions

06

What researchers measure

Primary outcomes

  1. 4-point scale for evaluation of Caregivers' feelings

    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.

    Time frame: 5 days

Secondary outcomes

  1. 4-point scale for evaluation of caregivers'competence

    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

    Time frame: 5 days

  2. 3-point scale for evaluation of caregivers' trust in their colleagues

    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).

    Time frame: 5 days

  3. Scale for evaluation of caregivers' degree of pleasure in coming to work

    The degree of pleasure in coming to work is assessed on a scale from 0 (not at all) to 10 (a lot).

    Time frame: 5 days

07

Study locations

2 sites
  • GHICL
    Lille, Nord 59000, France
  • Groupement des Hôpitaux de l'Institut Catholique de Lille
    Lille, 59000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06450249
Lead sponsor
Lille Catholic University
Responsible party
Sponsor
First posted
Jun 10, 2024
Start date
Jan 1, 2019
Primary completion
Dec 31, 2019
Completion
Jun 30, 2020
Last update
Jun 10, 2024

Study contacts

Marie Buttitta, PhD
principal investigator · GHICL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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