NCT03283891

Brief Summary

Haemodialysis (HD) patients constitute a vulnerable population with considerable health needs. They are often older persons with comorbid chronic conditions. Despite the substantial technical care they receive, these patients indicate that the quality of the human relationship that develops with nurses-the pivotal element in the care this population receives-can become therapeutic. This feature of the human relationship constitutes the cornerstone of the humanistic practice (caring practice) that all nurses should adhere to. However, according to some authors, such practice tends to fade over time. In 2012, a pilot study allowed to test an educational intervention based on Watson's Theory of Human Caring, the aim of which was to optimise nurses' humanistic practices. The intervention, first developed in Quebec and adapted in Switzerland by a committee of experts, was delivered to a group of nine HD nurses (Canton of Vaud, Switzerland) and evaluated. Preliminary results (qualitative and quantitative) showed the intervention to be highly feasible and acceptable. Moreover, in terms of preliminary outcomes, participating nurses appeared to strengthen their caring attitudes/behaviours toward HD patients post-intervention. Quantitative analyses of patients' questionnaires showed that HD patients perceived significant changes in nurses' caring attitudes/behaviours and maintained their level of quality of life (QoL) over time, which is a definite gain for this population. In light of these positive results, it is important to pursue this line of investigation in order to examine more accurately the intervention's effects on both nurses and patients. To this end, the investigators propose conducting a mixed-methods cluster randomised controlled trial (RCT) to assess the effects of an educational intervention to strengthen humanistic practice among nurses working in HD units in French Switzerland, on perceived quality of the nurse-patient relationship (NPR), nurses' team cohesion, nurses' quality of working life (QoWL), and HD patients' QoL. Knowledge acquired in the course of the study will contribute to strengthen nurses' humanistic practice, a key factor in HD patients' QoL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

September 13, 2017

Last Update Submit

February 2, 2021

Conditions

Keywords

Educational interventionWatson's theory of human caringQuality of working life of haemodialysis nursesQuality of life of haemodialysis patients

Outcome Measures

Primary Outcomes (3)

  • Nurse-patient relationship (NPR)

    NPR will be measured with the French version (EIIP-70) of the Caring Nurse-Patient Interaction Scale (CNPI-70). This tool comprises 70 items across 10 dimensions that capture each of Watson's 10 CF. It allows nurses to selfevaluate their frequency of caring attitudes/behaviours. More specifically, the EIIP-70 covers the following dimensions: humanism (6 items), hope (7 items), sensitivity (6 items), relationship (7 items), emotions (6 items), problem solving (6 items), teaching (11 items), assistance (10 items) and existential factors (6 items). Respondents must choose from five responses ranging from 1 (almost never) to 5 (almost always). This tool was validated on 377 nursing students and demonstrates good psychometric properties (Cronbach's alphas for the ten sub-dimensions range from .73 to .91).

    30 months

  • Nurses' team cohesion

    Team cohesion will be measured with the Group Environment Questionnaire (GEQ), which was subsequently adapted for work teams. Like the original, the French version contains 18 items and encompasses the four dimensions of team cohesion, namely, respondent's social-related attraction to the group (5 items, 1 of which is reverse scored), respondent's task-related attraction to the group (4 items, 2 of which are reverse scored), social-related group integration as perceived by respondent (4 items, 2 of which are reverse scored), and task-related group integration as perceived by respondent (5 items, 1 of which is reverse scored). The response scale ranges from 1 (strongly disagree) to 5 (strongly agree). The questionnaire was tested on a sample of nurses from another healthcare institution. No major comprehension difficulties emerged. Cronbach's alphas for the different dimensions run from 0.71 to 0.81.

    30 months

  • Nurses' quality of working life (QoWL) - nurses

    Quality of working life (QoWL) will be measured with a scale developed by Elizur and Shye (70), translated and validated in French. The scale is composed of 16 items exploring different dimensions of QoWL : psychological (items 1-4), physical (items 5-8), social (items 9-12) and cultural (items 13-16). Respondents must choose from six answers on a Likert scale ranging from "a very large part" to "very little".

    30 months

Secondary Outcomes (2)

  • Hemodyalisis patients' quality of life (QoL)

    30 months

  • Nurse-patient relationship (NPR) - patients

    30 months

Study Arms (2)

educational intervention

EXPERIMENTAL

Various pedagogical activities to mobilise Watson's ten Carative Factors

Other: Educational intervention - humanistic nursing practice

control

NO INTERVENTION

No intervention during the different times of measurement. Educational intervention will be delivered after the last measure.

Interventions

Four educational sessions: * Acquisition of core concepts of caring practice (I) * Acquisition of core concepts of caring practice (II) * Search for meaning: Influencing hope in persons through humanistic practice * Enacting different caring attitudes and behaviours in an intermediary simulation exercise with actor

educational intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses:
  • have at least 6 months' work experience in the department;
  • consent to take part in the study. In addition, nurses who intend to leave the HD unit in the 3 months to come will be excluded
  • Patients
  • be at least 18 years of age and under active treatment for at least 6 months;
  • understand and read French;
  • able to provide informed consent.

You may not qualify if:

  • Nurses:
  • \. intention to leave the HD unit in the 3 months after the beginning of the project
  • Patients
  • being diagnosed with dementia
  • being a new HD patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hôpital du Jura

Delémont, Canton of Jura, Switzerland

Location

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Location

Hôpital de Morges - Ensemble hospitalier de la Côte

Morges, Canton of Vaud, Switzerland

Location

Hôpital intercantonal de la Broye (HIB)

Payerne, Canton of Vaud, Switzerland

Location

Établissements hospitaliers du Nord vaudois (eHnv)

Yverdon-les-Bains, Canton of Vaud, Switzerland

Location

Hôpital du Valais - Martigny

Martigny-Ville, Valais, Switzerland

Location

Hôpital Riviera-Chablais (HRC)

Monthey, Valais, Switzerland

Location

Hôpital du Valais - Sierre

Sierre, Valais, Switzerland

Location

Hôpital du Valais - Sion

Sion, Valais, Switzerland

Location

Hôpitaux Universitaires de Genève (HUG)

Geneva, Switzerland

Location

Related Publications (2)

  • Antonini M, Bellier-Teichmann T, O'reilly L, Cara C, Brousseau S, Weidmann J, Roulet-Schwab D, Ledoux I, Konishi M, Pasquier J, Delmas P. Effects of an educational intervention to strengthen humanistic practice on haemodialysis nurses' caring attitudes and behaviours and quality of working life: a cluster randomised controlled trial. BMC Nurs. 2021 Dec 20;20(1):255. doi: 10.1186/s12912-021-00729-6.

  • Delmas P, O'Reilly L, Cara C, Brousseau S, Weidmann J, Roulet-Schwab D, Ledoux I, Pasquier J, Antonini M, Bellier-Teichmann T. Effects on nurses' quality of working life and on patients' quality of life of an educational intervention to strengthen humanistic practice among hemodialysis nurses in Switzerland: a protocol for a mixed-methods cluster randomized controlled trial. BMC Nurs. 2018 Nov 21;17:47. doi: 10.1186/s12912-018-0320-0. eCollection 2018.

Study Officials

  • Philippe Delmas, PhD

    Haute Ecole de la Santé La Source

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Mixed methods cluster randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Inf, Ph.D, Ex.MBA., Professeur Ordinaire HES-SO

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 14, 2017

Study Start

September 1, 2017

Primary Completion

July 24, 2018

Study Completion

February 1, 2020

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations