NCT06886581

Brief Summary

The goal of this cluster clinical trial is to evaluate the effectiveness of online training course, targeted to unit leaders to improve staff's evidence-based skills (individual outcomes), EBP implementation (team-based outcomes), and the quality of care (organisational outcomes). Feasibility and fidelity of the intervention will be assessed as well. The main questions it aims to answer are:

  • Participants will join in a seven-months online training course in small group or practice as usual.
  • Seven course modules, read course material, prepare assignments, join in peer discussions.
  • Self-assessment, self-reflection and give course feedback.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress59%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

March 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 5, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

March 14, 2025

Last Update Submit

June 10, 2025

Conditions

Evidence-Based PracticeLeadership

Keywords

cluster randomised trialevidence-basedleadership

Outcome Measures

Primary Outcomes (1)

  • The Evidence-based Practice Questionnaire (EBPQ)

    The Evidence-based Practice Questionnaire (EBPQ) assess the implementation of evidence-based practice (24 items, score 1-7, three sub-scales: 1) the knowledge/skills (14 items, score 1-7, 1=Poor-7=Best, the range 14-98, a higher score represents greater knowledge in EBP); 2) the attitudes (4 items, score 1-7, the range 4-28; a higher score represents more a positive attitude toward EBP; 3) an evidence-based practice (6 items, score 1-7, 1=Never, 7=Frequently, range 6-42); the higher score is better.

    From enrollment to the end of training at 7 months.

Secondary Outcomes (11)

  • Self-Esteem Scale (RSE)

    From enrollment to the end of training at 7 months.

  • The General Self-Efficacy Scale (GSE)

    From enrollment to the end of training at 7 months.

  • The Implementation Leadership Scale (ILS) - Staff version

    From enrollment to the end of training at 7 months.

  • The Implementation Leadership Scale (ILS) - Supervisor version

    From enrollment to the end of training at 7 months.

  • The quality of care: Number of Patient Deaths (Register Data)

    From enrollment to the end of training at 7 months.

  • +6 more secondary outcomes

Other Outcomes (7)

  • Course feedback - survey

    After the course, at month 7.

  • Feasibility and fidelity: number of total loggs in each module (f)

    After the course, at month 7.

  • Feasibility and fidelity: number of participants who logged in each module (n)

    After the course, at month 7.

  • +4 more other outcomes

Study Arms (2)

Evidence-based leadership training

EXPERIMENTAL

The participants in the experimental group will join a seven months online course aiming to improve the evidence-based leadership competences.

Behavioral: Evidence-based leadership training

Passive control group

NO INTERVENTION

A passive control group

Interventions

Evidence-based leadership trainingBEHAVIORAL

The structure of the course will follow the steps of the evidence-based approach: (1) each participant will identify their specific unit problem to be solved together with the team and unit leader will work with this problem during the course; (2) organisational data will be collated and analysed to understand the key problem of the unit; (3) scientific literature will be searched for, and critically appraised; (4) the views of stakeholders (patients, family members, etc.) will be considered along with implications; and (5) all sources of information will be collated together and the solution will be implemented into practice; the real situation will be evaluated. Each module includes specific learning material (power points, scientific articles), peer-group discussions, clinical exercises, and self-assessment and self-reflection. The unit leaders will work together their unit members. The course will be run in small group (about 15/agroup) and supported by tutors.

Evidence-based leadership training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have shown their willingness to join the study,
  • unit leaders have an official managerial position at the study organisation,
  • unit have a leaders with a professional licence to work in health or social care sector,
  • unit leaders represent any gender,
  • are able to speak, read and write in Finnish, and
  • have given informed consent to join the study.

You may not qualify if:

  • Those staff members who are off duty during the recruitment period (family leave, long-term sick leave, study leave, or any other reason).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Helsinki

Helsinki, South Finland, 20014, Finland

RECRUITING

Related Publications (3)

  • Hu 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.

    PMID: 39510773BACKGROUND

  • Valimaki 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.

    PMID: 37580090BACKGROUND

  • Valimaki M, Satamo M, Yang M. Effectiveness of an online training course to improve evidence-based leadership practices among unit leaders: study protocol for a cluster randomised two-arm controlled trial (EVILEAD). Trials. 2025 Nov 14;26(1):508. doi: 10.1186/s13063-025-09207-9.

    PMID: 41239490DERIVED

Related Links

Study Officials

  • Maritta A Välimäki, PhD, Professor

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maritta A Välimäki, PhD

CONTACT

+358-40-5599235maritta.valimaki@helsinki.fi

Maija Satamo, RN, MSc

CONTACT

+358-50-4766116maijakatriina.satamo@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 20, 2025

Study Start

June 5, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Research data will include personal information of the participants. Thereore, entire research data cannot be make publicly available as it is. Meta-data of the study will be published.

Locations

FI(1)