Evidence-based Leadership in Nurse Leaders-CH (EVILEAD-CH)

November 28, 2023 updated by: Maritta Välimäki, University of Turku

Online Training to Improve Evidence-based Leadership Competencies Among Nurse Leaders in China: Study Protocol for a Randomised Feasibility Trial (EVILEAD-CH)

This study protocol describes a randomised feasibility trial that will evaluate the feasibility and preliminary effectiveness of the training course to improve evidence-based leadership competencies among nurse leaders working in hospitals in China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will include a 6-months training intervention for nurse leaders working in hospital settings in China. About 150 nurse leaders fulfilling the eligibility criteria will be randomly allocated (1:1) to participate in the online training course about evidence-based leadership or conventional leadership training course (reading material only)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Tumor Hospital
      • Changsha, Hunan, China, 410013
        • Xiangya Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Official managerial role in the study organisation (hospital, clinic, ward level), which give them an authority to act as a nurse leader and monitor, develop and evaluate the care
  • Being in full time or part time position
  • All sex
  • Aged up to 65 years
  • Working in the study sites at the time of the recruitment
  • Ability to read and write simple Chinese language
  • Willingness to join the study based on their own free will
  • Informed consent obtained

Exclusion Criteria:

  • Non-nursing professionals in leadership position (e.g. physician, psychologist, pharmacist, dietician/nutritionist, dentist, physiotherapist, radiation therapist, paramedic, occupational therapist, social worker, or disability worker)
  • Speaking only other languages than simple Chinese
  • Out of duty during the recruitment period for family leave, long term sick leave, study leave or any other reason

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Evidence-based leadership training
The training course will take 6 months. It is divided into seven online modules. Participants join the course based on pre-structured schedule. The progress of the training course will follow specific steps to improve participants' evidence-based leadership competencies. First, each participant identifies one leadership problem on daily practice. Second, organisational data will be collected and analysed to increase the understanding of the key problem. Third, scientific literature will be searched, identified and critically appraised to find solutions. Fourth, the views of stakeholders (patients, clinicians, family members, etc.) are considered together with ethical implications. And last, all sources of information are critically appraised, new solution will be designed and implemented into the practice, and evaluated in real world context. Each module includes specific learning material. Trained tutors are responsible for mentoring each module.
Other: Evidence-based leadership training
7-modules online training over six months mentored by tutors. Independent familiarisation of reading material, peer-group discussions, self-reflection, assignments, tutor's feedback.
Active Comparator: Conventional training
The participants will join a training course with the same structure, topics, and timing as the experimental group. However, training in this group is based on independent learning methods. The participants have access to the separate learning platform, which includes reading material to be read independently. No group discussions with peers, self-reflection, assignments, or support from tutors will be offered.
Other: Conventional training
7-modules online training over six months. Independent reading only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of the intervention
Time Frame: 6 months
The degree of execution (success and failure of execution) of the intervention protocol by calculating the number of logins for each module and all participants
6 months
Adherence in the course
Time Frame: 6 months
Adherence in the course by calculating the number of returned course tasks out of all possible tasks
6 months
Adherence in the course tasks
Time Frame: 6 months
Adherence in the course by calculating the number of returned course tasks by each participant
6 months
Drop-out rate
Time Frame: 6 months
The drop-out rate calculated by the number of participants who left the study early (no follow-up data)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability in recruitment
Time Frame: Baseline
The number of nurse leaders who accepted (or refused) the invitation to participate in the research study
Baseline
Feasibility of the eligibility criteria
Time Frame: Baseline
The number of nurse leaders who fulfilled eligibility criteria
Baseline
Feasibility of the outcome instruments for measuring the potential effectiveness of the online course
Time Frame: Baseline and 6 months
The number of missing variables of each returned instrument
Baseline and 6 months
Evidence-based practice, knowledge, and attitudes (Evidence Based Practice Questionnaire [EBPQ])
Time Frame: Baseline and 6 months
Evidence-Based Practice Questionnaire (EBPQ)
Baseline and 6 months
Self-efficacy (General Self-Efficacy Scale [GSE])
Time Frame: Baseline and 6 months
General Self-Efficacy Scale (GSE)
Baseline and 6 months
Self-esteem (Rosenberg Self-Esteem Scale [RSE])
Time Frame: Baseline and 6 months
Rosenberg Self-Esteem Scale (RSE)
Baseline and 6 months
Intention to leave (questionnaire)
Time Frame: Baseline and 6 months
Three-item questionnaire
Baseline and 6 months
Leadership skills (Multifactor Leadership Questionnaire [MLQ])
Time Frame: Baseline and 6 months
Multifactor Leadership Questionnaire (MLQ)leadership skills
Baseline and 6 months
Course feedback (questionnaire)
Time Frame: Baseline and 6 months
Eight-item questionnaire
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turku

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hunan Cancer Hospital
Central South University
Sichuan University
Swinburne University of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maritta A Välimäki, Prof, University of Turku, Finland, mava@utu.fi

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHEvidence

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

According to the ethical reasons

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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