NCT05244512

Brief 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 Finland.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 7, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

February 7, 2022

Last Update Submit

June 6, 2023

Conditions

Keywords

feasibility, randomised controlled trial, training

Outcome Measures

Primary Outcomes (4)

  • 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

    6 months

  • Adherence in the course

    Adherence in the course by calculating the number of returned course tasks out of all possible tasks

    6 months

  • Adherence in the course tasks

    Adherence in the course by calculating the number of returned course tasks by each participant

    6 months

  • Drop-out rate

    The drop-out rate calculated by the number of participants who left the study early (no follow-up data)

    6 months

Secondary Outcomes (9)

  • Acceptability in recruitment

    Baseline

  • Feasibility of the eligibility criteria

    Baseline

  • Feasibility of the outcome instruments for measuring the potential effectiveness of the online course

    Baseline and 6 months

  • Leadership skills (Multifactor Leadership Questionnaire [MLQ])

    Baseline and 6 months

  • Evidence-based practice, knowledge, and attitudes (Evidence Based Practice Questionnaire [EBPQ])

    Baseline and 6 months

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Other: Conventional training

Interventions

7-modules online training over six months mentored by tutors. Independent familiarisation of reading material, peer-group discussions, self-reflection, assignments, tutor's feedback.

Evidence-based leadership training

7-modules online training over six months. Independent reading only.

Conventional training

Eligibility Criteria

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

You may qualify if:

  • 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 Finnish language
  • Willingness to join the study based on their own free will
  • Informed consent obtained

You may not qualify if:

  • 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 Finnish (e.g. Swedish or English)
  • Out of duty during the recruitment period for family leave, long term sick leave, study leave or any other reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsingin kaupunki, psykiatria

Helsinki, South Finland, 20014, Finland

Location

Related Publications (1)

  • 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.

Study Officials

  • Maritta A Välimäki

    University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Tutors and researchers involved in the screening and baseline assessment will not be blind to the interventions provided during the trial. Participants, care providers and statistician will be kept blind to the study conditions.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A single-blind, individually randomised, two-arm parallel-group controlled feasibility trial design will be used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 17, 2022

Study Start

September 26, 2022

Primary Completion

May 30, 2023

Study Completion

December 31, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

According to the ethical reasons

Locations