NCT06450249

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 4, 2024

Last Update Submit

June 4, 2024

Conditions

Keywords

HumanitudeCare methodologyAgitated behaviorQuality of careHealth professionalWell beingMedical education

Outcome Measures

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.

    5 days

Secondary Outcomes (3)

  • 4-point scale for evaluation of caregivers'competence

    5 days

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

    5 days

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

    5 days

Study Arms (1)

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 sessionsBehavioral: Self-administered questionnaire

Interventions

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

Healthcare professionals

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

Healthcare professionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GHICL

Lille, Nord, 59000, France

Location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, 59000, France

Location

MeSH Terms

Conditions

Psychomotor Agitation

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Marie Buttitta, PhD

    GHICL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 10, 2024

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations