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Nurse-Patient RelationsNCT06878820

Nurses in the Lead - Nursing Leadership and Autonomy in Function Focused Care in Hospital

An observational study of Nurse-Patient Relations and Implementation Research, run by Leiden University Medical Center at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this prospective before-after study (observational) is to implement Function Focused Care in Hospital (FFCiH), paying specific attention to the role of nurses and how they can take the leadership and autonomy in the interprofessional collaboration regarding FFCiH. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Function Focused Care
How many people
425 participants
Where
3 sitesNetherlands
Study dates
18 Nov 2024to 30 Oct 2025
How long will I take part?
10 Days
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The domain of this study consists of * nurses, physiotherapists, doctors, other member of the interprofessional team (e.g. occupational therapist), * patients admitted to a surgical respectively internal medicine ward of a hospital, and their informal caregivers.

Who may be able to join

  • All (student-)nurses working in the participating wards are expected to be involved in application of FFC and role development with regards to leadership and autonomy of nurses and therefore considered to be eligible for participation in the study.
  • All professional groups that are part of the interprofessional team of the ward and who work in the participating wards are expected to collaborate with the nursing in their daily care and therefore considered to be eligible for participation in this study.
  • All patients admitted to the participating wards of the 2 hospitals receiving care either before or after the implementation of FFC and the patients informal caregiver as determined by the patient.

Who cannot join

  • No exclusion criteria were defined for nurses and student nurses.
  • Physiotherapists, doctors and other member of the interprofessional team;
  • No exclusion criteria were defined for physiotherapists, doctors and other members of the interprofessional team.
  • Patients and informal caregivers:
  • A life-threatening situation or in a terminal phase upon admission (only applicable to patients)
  • Not mastering the Dutch language;
Show all 9Show fewer
  • Not able to communicate adequately, based on a below threshold score on the MOCA or the FAST (only applicable to patients)
  • A second hospitalization on one of the participating wards after being included in the study during the study period;
  • An hospitalization < 48 hours

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Stichting Slingeland Ziekenhuis

    Doetinchem, 3584 CS

  • Leiden University Medical Center

    Leiden

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

About this study

Official title: Nurses in the Lead - Nursing Leadership and Autonomy in Function Focused Care in Hospital: a Prospective Before-after Study

The goal of this prospective before-after study (observational) is to implement Function Focused Care in Hospital (FFCiH), paying specific attention to the role of nurses and how they can take the leadership and autonomy in the interprofessional collaboration regarding FFCiH. To reach this aim, the researchers defined two sub-objectives:

  1. to identify barriers and facilitators (determinants) for nursing autonomy and leadership and application FFCiH in the interprofessional collaboration on a surgical and internal medicine ward to design a tailored implementation strategy for FFCiH. 2. to evaluate the effectiveness of the implementation strategy on nursing leadership and the application of FFCiH.
Read more

The investigators developed two work packages related to the two sub-objectives: identifying determinants and strategies for the successful application of FFCiH and nurse leadership, among others, by introducing nurse champions and evaluating their effect on the application of FFCiH. The primary endpoint is the level of application of FFCiH as reflected in adherence to and coverage of FFCiH in daily nursing care.

The secondary endpoints are: 1) for nurses: the nurses' role development with regards to leadership and autonomy in the application of FFCiH by ward nurses and nurse champions, leadership competencies of ward nurses, and autonomy of ward nurses and 2) for patients: physical functioning and independency in mobility and ADL.

Researchers will compare FFCiH with usual care to see if there are differences regarding the outcome measurements.

The study population consists of nurses, physiotherapists, doctors, other member of the interprofessional team, hospitalized patients and their relatives.

Intervention: FFCiH focuses on stimulating nurses to promote patients' self-reliance in daily functioning, encouraging the patients' engagement in daily activities and, helping patients to attain and maintain their highest level of function and increasing time spent in physical activity. FFCiH is a proven effective approach for promoting patients' physical functioning and mobility.

Read the detailed description

The investigators will conduct a prospective before-after multicenter study, including a process evaluation, with a mixed methods approach in two university medical centers. In the preparation phase before the before-after study the tailored implementation strategy for FFCiH will be developed. Between the before and after phases of the study, the investigators will implement in two or three cyclic processes the FFCiH approach by strengthening nursing leadership and autonomy in the application of FFCiH in the interprofessional collaboration, using the predefined tailored implementation strategy.

Being tested
Function Focused Care
Keywords
function focused care, implementation, leadership, mobility, ADL, nurses in the lead, nursing care
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Function Focused CareBehavioural

    Also called FFC, FFCiH, Function Focused Care in Hospital

    FFCiH is an effective nursing approach and focuses on stimulating nurses to promote patients' self-reliance in daily functioning, encouraging the patients' engagement in daily activities and helping patients to attain and maintain their highest level of function and to increase time spent in physical activity.

Study groups in NCT06878820
Study groupRoleWhat they receive
Function Focused CareNurses provide care according to Function Focused Care in Hospital (FFCiH) principles. After implementation of this intervention, all patients admitted to the selected wards in the hospital receive FFCiH.
Receives: Behavioral: Function Focused Care
Usual CareBefore implementation of Function Focused Care in Hospital, nurses provide care as usual to patients admitted to the selected wards in hospital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of leadership using the Leadership Practices Inventory (LPI) - Nurses

    The LPI questionnaire consist of 30 leadership behaviors presented as behavioral statements, that can categorized into 5 subscales, representing five leadership practices: 1) Model the way, 2) Inspire a shared vision, 3) Challenge the process, 4) Enable others to act, and 5) Encourage the heart. Each of these statement can be scored on a 10-point Likert scale, for which a higher score indicate more frequent the respondent engage in the leadership behavior. The internal reliability of the LPI in nurses ranges from 0.66 to 0.96.36 The original questionnaire has been translated into Dutch.

    Measured: up to four weeks directly before implementation & up to four weeks directly after implementation

  2. Level of autonomy - Nurses

    Using the Maastricht Autonomy Questionnaire (MAQ), which consists of 10 items scored on a five-point Likert scale ranging from very little to very much.The total score ranges from 10 to 50. Higher scores indicate more job autonomy. The questionnaire includes information on job control and freedom in work tasks and methods. It measures the opportunity for staff to determine a variety of task elements, such as the pace of work and the work goals. A sample item is: 'My work offers me the opportunity to interrupt my job whenever I want.' Current study findings confirmed good internal consistency (Cronbach's alpha=0.90).

    Measured: up to four weeks directly before implementation & up to four weeks directly after implementation

Secondary outcomes (5)

  1. Adherence (fidelity)

    Refers to the extent to which FFCiH has been applied as intended, and will be measured with the key components of FFCiH, such as goal setting with patient, individualized care plan, encouragement of patient's active involvement in ADL and evaluation the level of the patient's ADL-independence and mobility.

    This outcome will be measured with

    1. qualitative focus group interviews with the multidisciplinary team and individual interviews with patients. Topics include the key components of FFCiH.
    2. Screening of electronic patient records. The electronic patient records will be screened on the number of reported short- and long-term goals and the amount of nursing report that contains information about bathing, dressing, mobility or transfers.

    Measured: up to four weeks after implementation

  2. Level of mobility - Patients

    Measured using the AMEXO. this measure is the Amsterdam UMC extension of the John Hopkins Highest Level of Mobility (AMEXO) scale. The instrument consist of twelve categories representing the highest level of mobility. The response categories includes: 1= bed lying; 2= bed turn self/activity; 3= bed sit at edge; 4= chair transfer; 5= stand 1 minute; 6=walk 10+ steps; 7=walk 25+ feet; 8=walk 250+ feet ,9= 225m; 10= 450m; 11= 750m; 12= 1125m.:.'. The higher the total score, the higher the level of independence.

    Measured: <72 hours after hospital admission and at discharge (assessed up to 3 days)

  3. Level of independence in Activities of Daily Livings - patients

    Measured with the KATZ-ADL. This measurement consists of 6 items: bathing, dressing, toilet visit, movement inside the house, continence, feeding. The items score on a 2 point scale: dependent or independent.

    Measured: <72 hours after hospital admission and at discharge (assessed up to 3 days)

  4. Level of coverage (reach)

    Refers to the extent to which patients actually receive FFCiH, and measured by determining the extent to which patients who qualify for FFCiH actually receive it.

    This outcome will be measured with 1) qualitative focus group interviews with the multidisciplinary team and individual interviews with patients. Topics include the key components of FFCiH. 2) Screening of electronic patient records. The electronic patient records will be screened on the number of reported short- and long-term goals and the amount of nursing report that contains information about bathing, dressing, mobility or transfers.

    Measured: up to four weeks after implementation

  5. Numbers of days stayed in the hospital - patients

    Based on the findings in our previous study and known from clinical practice, we know that discharge from hospital highly depends on independence in ADL and/or mobility. As a result, it is expected that a recovery of independence in ADL and mobility primarily does not lead to higher levels of independence in ADL and mobility at discharge, but to a shorter admission with the same level of independence in ADL and mobility. Therefore, we also will collect data from patient files regarding the duration of hospital admission.

    Measured: At discharge (assessed up to 14 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study start18 Nov 2024
  3. Primary completion11 Oct 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
425 participants (actual)
Target duration
10 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06878820
Sponsor's protocol ID
134718
Other IDs
10040022230013
Status last verified
Aug 2026
First submitted
22 Nov 2024
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kok S, Schoonhoven L, Vernooij LM, Reitsma JB, Verstraten C, Metzelthin SF, Bleijenberg N, de Man-van Ginkel JM. The effectiveness of Function Focused Care among patients acutely admitted to hospital: A stepped wedge cluster trial. Int J Nurs Stud. 2024 Dec;160:104893. doi: 10.1016/j.ijnurstu.2024.104893. Epub 2024 Sep 4.

    PubMed 39321557

  • Kok S, de Man-van Ginkel JM, Verstraten C, Resnick B, Metzelthin SF, Bleijenberg N, Schoonhoven L. Function focused care in hospital: A mixed-method feasibility study. Int J Nurs Stud Adv. 2021 Sep 29;3:100045. doi: 10.1016/j.ijnsa.2021.100045. eCollection 2021 Nov.

    PubMed 38746732

Questions about this trial

What is this clinical trial studying?

An observational study of Nurse-Patient Relations and Implementation Research, run by Leiden University Medical Center at 3 sites in Netherlands.

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 3 inclusion and 9 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. 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?

Level of leadership using the Leadership Practices Inventory (LPI) - Nurses (time frame: up to four weeks directly before implementation & up to four weeks directly after implementation). The study lists 2 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 NCT06878820, which also lists 2 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 28 Aug 2026.

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