Delivery of Health CareHumanitudeNCT06450249
Effects of the Humanitude® Care Methodology on Health Professionals' Perception
An observational study of Delivery of Health Care and Education, Medical, run by Lille Catholic University at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delivery of Health Care, Education, Medical, Caregiver
- What is being tested?
- Humanitude® Care Methodology (HCM) training sessions and Self-administered questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 455 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2019to 30 Jun 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Caregivers taken part in a Humanitude® training course
- Caregivers agreeing to complete pre- and post-training questionnaires
Who cannot join
- Caregiver not completing the questionnaire at one of the 2 stages of the assessment (before or after)
Trial locations and contacts
2 sites in 1 country.
France2 sites
GHICL
Lille, Nord, 59000
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, 59000
About this study
Official title: 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.
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.
- Conditions
- Delivery of Health Care, Education, Medical, Caregiver
- Being tested
- Humanitude® Care Methodology (HCM) training sessions, Self-administered questionnaire
- Keywords
- Humanitude, Care methodology, Agitated behavior, Quality of care, Health professional, Well being, Medical education
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humanitude® Care Methodology (HCM) training sessionsBehavioural
During a five-day training session healthcare professionals are trained to the HCM within their own care unit
Self-administered questionnaireBehavioural
The self-administered questionnaire will be completed before and after participation in Humanitude® Care Methodology training sessions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Humanitude® Care Methodology (HCM) training sessions; Behavioral: Self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (3)
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
Measured: 5 days
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).
Measured: 5 days
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).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery of Health CareStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Buttitta, PhD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450249
- Sponsor's protocol ID
- RNIPH-2021-23
- Acronym
- Humanitude
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Humanitude® Care Methodology on Improving Health Professionals' Perception of Competence and Emotional State
- ClinicalTrials.gov ID
- NCT06450249
- Acronym / sponsor ID
- Humanitude / RNIPH-2021-23
- Conditions
- Delivery of Health Care, Education, Medical, Caregiver
- Keywords
- Humanitude, Care methodology, Agitated behavior, Quality of care, Health professional, Well being, Medical education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Jun 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare professionals | – | Behavioral: Humanitude® Care Methodology (HCM) training sessions, Behavioral: Self-administered questionnaireHealthcare 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Caregivers taken part in a Humanitude® training course
- Caregivers agreeing to complete pre- and post-training questionnaires
Key exclusion criteria (1 listed)
- Caregiver not completing the questionnaire at one of the 2 stages of the assessment (before or after)
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 |
|---|---|---|
| Humanitude® Care Methodology (HCM) training sessionsDuring a five-day training session healthcare professionals are trained to the HCM within their own care unit | Behavioural | Healthcare professionals |
| Self-administered questionnaireThe self-administered questionnaire will be completed before and after participation in Humanitude® Care Methodology training sessions | Behavioural | Healthcare professionals |
Primary outcome
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.
3 secondary outcomes
4-point scale for evaluation of caregivers'competence
Time frame: 5 days
3-point scale for evaluation of caregivers' trust in their colleagues
Time frame: 5 days
Scale for evaluation of caregivers' degree of pleasure in coming to work
Time frame: 5 days
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 10 Jun 2024.
Related trials for Delivery of Health Care
Active, not recruiting
Enhancing Telemedicine for T2D
Type 2 Diabetes
Not yet recruiting
King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
Heart Failure, Cardiac Rehabilitation
Not yet recruiting
Feasibility of Implementing the Internet-Delivered Stress Recovery Intervention FOREST for Healthcare Staff in a Real-World Healthcare Setting
Stress (Psychology)
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
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.
Marie Buttitta, PhD principal investigator
GHICL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delivery of Health Care and Education, Medical, run by Lille Catholic University at 2 sites in France.
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 2 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
4-point scale for evaluation of Caregivers' feelings (time frame: 5 days). 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 10 Jun 2024.