LeadershipEVILEAD-CHNCT05244499
Evidence-based Leadership in Nurse Leaders-CH
A study testing Evidence-based leadership training and Conventional training in people with Leadership, run by University of Turku at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leadership
- What is being tested?
- Evidence-based leadership training and Conventional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jul 2022to 30 May 2023
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan Tumor Hospital
Changsha, Hunan, 410013
Xiangya Hospital
Changsha, Hunan, 410013
About this study
Official title: 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.
Read the 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)
- Conditions
- Leadership
- Being tested
- Evidence-based leadership training, Conventional training
- Keywords
- feasibility, randomised controlled trial, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based leadership trainingOther
7-modules online training over six months mentored by tutors. Independent familiarisation of reading material, peer-group discussions, self-reflection, assignments, tutor's feedback.
Conventional trainingOther
7-modules online training over six months. Independent reading only.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based leadership training | Experimental | 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. Receives: Other: Evidence-based leadership training |
| Conventional training | Active comparator | 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. Receives: Other: Conventional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
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
Measured: 6 months
Adherence in the course
Adherence in the course by calculating the number of returned course tasks out of all possible tasks
Measured: 6 months
Adherence in the course tasks
Adherence in the course by calculating the number of returned course tasks by each participant
Measured: 6 months
Drop-out rate
The drop-out rate calculated by the number of participants who left the study early (no follow-up data)
Measured: 6 months
Secondary outcomes (9)
Acceptability in recruitment
The number of nurse leaders who accepted (or refused) the invitation to participate in the research study
Measured: Baseline
Feasibility of the eligibility criteria
The number of nurse leaders who fulfilled eligibility criteria
Measured: Baseline
Feasibility of the outcome instruments for measuring the potential effectiveness of the online course
The number of missing variables of each returned instrument
Measured: Baseline and 6 months
Leadership skills (Multifactor Leadership Questionnaire [MLQ])
Multifactor Leadership Questionnaire (MLQ)leadership skills
Measured: Baseline and 6 months
Evidence-based practice, knowledge, and attitudes (Evidence Based Practice Questionnaire [EBPQ])
Evidence-Based Practice Questionnaire (EBPQ)
Measured: Baseline and 6 months
Self-efficacy (General Self-Efficacy Scale [GSE])
General Self-Efficacy Scale (GSE)
Measured: Baseline and 6 months
Self-esteem (Rosenberg Self-Esteem Scale [RSE])
Rosenberg Self-Esteem Scale (RSE)
Measured: Baseline and 6 months
Intention to leave (questionnaire)
Three-item questionnaire
Measured: Baseline and 6 months
Course feedback (questionnaire)
Eight-item questionnaire
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start13 Jul 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeadershipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind, individually randomised, two-arm parallel-group controlled feasibility trial design will be used.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Central South University, Sichuan University, Swinburne University of Technology, Hunan Cancer Hospital
- Responsible party
- Principal investigator, Maritta Välimäki, University of Turku
- Investigators
- Maritta A Välimäki, Prof, Principal investigator, University of Turku, Finland, mava@utu.fi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244499
- Sponsor's protocol ID
- CHEvidence
- Acronym
- EVILEAD-CH
- Status last verified
- Nov 2023
- First submitted
- 7 Feb 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the ethical reasons
Publications
Hu S, Liu S, Hu H, Hu J, Shumaila B, Chen W, Yang Q, Liu G, Valimaki M, Li X. Nurse leaders' perspectives on a feasibility randomized controlled trial evaluating an online training program to improve evidence-based leadership: a qualitative descriptive study. BMC Nurs. 2026 May 23;25(1):599. doi: 10.1186/s12912-026-04779-6.
PubMed 42177553Hu S, Chen W, Satamo M, Loyttyniemi E, Yang M, Liu G, Chen J, Tang Y, Varpula J, Li X, Valimaki M. Online training to improve evidence-based leadership competencies among nurse leaders in China: a feasibility randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e088386. doi: 10.1136/bmjopen-2024-088386.
PubMed 39510773Valimaki MA, Kirsi H, Yang M, Lantta T, Varpula J, Liu G, Tang Y, Chen W, Hu S, Chen J, Loyttyniemi E, Li X. Online training to improve evidence-based leadership competencies among nurse leaders in Finland and China: study protocols for two randomised feasibility trials. BMJ Open. 2023 Aug 14;13(8):e067306. doi: 10.1136/bmjopen-2022-067306.
PubMed 37580090
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Training to Improve Evidence-based Leadership Competencies Among Nurse Leaders in China: Study Protocol for a Randomised Feasibility Trial (EVILEAD-CH)
- ClinicalTrials.gov ID
- NCT05244499
- Acronym / sponsor ID
- EVILEAD-CH / CHEvidence
- Conditions
- Leadership
- Keywords
- feasibility, randomised controlled trial, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Central South University, Sichuan University, Swinburne University of Technology, Hunan Cancer Hospital
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 17 Feb 2022 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A single-blind, individually randomised, two-arm parallel-group controlled feasibility trial design will be used.
| Arm | Type | Receives |
|---|---|---|
| Evidence-based leadership training | Experimental | Other: Evidence-based leadership trainingThe 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. |
| Conventional training | Active comparator | Other: Conventional trainingThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Evidence-based leadership training7-modules online training over six months mentored by tutors. Independent familiarisation of reading material, peer-group discussions, self-reflection, assignments, tutor's feedback. | Other | Evidence-based leadership training |
| Conventional training7-modules online training over six months. Independent reading only. | Other | Conventional training |
Primary outcome
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
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
Adherence in the course tasks
Time frame: 6 months
Adherence in the course by calculating the number of returned course tasks by each participant
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)
9 secondary outcomes
Acceptability in recruitment
Time frame: Baseline
Feasibility of the eligibility criteria
Time frame: Baseline
Feasibility of the outcome instruments for measuring the potential effectiveness of the online course
Time frame: Baseline and 6 months
Leadership skills (Multifactor Leadership Questionnaire [MLQ])
Time frame: Baseline and 6 months
Evidence-based practice, knowledge, and attitudes (Evidence Based Practice Questionnaire [EBPQ])
Time frame: Baseline and 6 months
Self-efficacy (General Self-Efficacy Scale [GSE])
Time frame: Baseline and 6 months
Self-esteem (Rosenberg Self-Esteem Scale [RSE])
Time frame: Baseline and 6 months
Intention to leave (questionnaire)
Time frame: Baseline and 6 months
Course feedback (questionnaire)
Time frame: Baseline and 6 months
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 29 Nov 2023.
- Derived from this study: PubMed 42177553Hu S, Liu S, Hu H, Hu J, Shumaila B, Chen W, Yang Q, Liu G, Valimaki M, Li X. Nurse leaders' perspectives on a feasibility randomized controlled trial evaluating an online training program to improve evidence-based leadership: a qualitative descriptive study. BMC Nurs. 2026 May 23;25(1):599. doi: 10.1186/s12912-026-04779-6.
- Derived from this study: PubMed 39510773Hu S, Chen W, Satamo M, Loyttyniemi E, Yang M, Liu G, Chen J, Tang Y, Varpula J, Li X, Valimaki M. Online training to improve evidence-based leadership competencies among nurse leaders in China: a feasibility randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e088386. doi: 10.1136/bmjopen-2024-088386.
- Derived from this study: PubMed 37580090Valimaki MA, Kirsi H, Yang M, Lantta T, Varpula J, Liu G, Tang Y, Chen W, Hu S, Chen J, Loyttyniemi E, Li X. Online training to improve evidence-based leadership competencies among nurse leaders in Finland and China: study protocols for two randomised feasibility trials. BMJ Open. 2023 Aug 14;13(8):e067306. doi: 10.1136/bmjopen-2022-067306.
- Individual participant dataSharing planned: No. According to the ethical reasons
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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.
Maritta A Välimäki, Prof principal investigator
University of Turku, Finland, mava@utu.fi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based leadership training and Conventional training in people with Leadership, run by University of Turku at 2 sites in China.
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 8 inclusion and 3 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 29 Nov 2023. 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 China. 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?
Acceptability of the intervention (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244499, which also lists 3 linked publications.
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 29 Nov 2023.