NCT06678347

Brief Summary

The goal of this intervention study is to evaluate a group intervention programme that aims to support first-line healthcare managers in promoting their employees' recovery through a "leadership for recovery". In the study, the researchers will investigate if the intervention programme can improve the recovery (including sleep) of healthcare employees. The intervention programme consists of 6 group sessions for managers. The main question the study aims to answer are: \- Can a group-based intervention programme with a focus on strengthening first-line healthcare managers' leadership for recovery improve their employees' recovery? The intervention programme will be delivered to first-line healthcare managers in Swedish hospital care settings. Researchers will compare survey, diary and actigraphy data between employees of 1) managers who participate in the programme and 2) managers who has not participated in the programme.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
960

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

2 active sites

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 Start

First participant enrolled

June 13, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

November 5, 2024

Last Update Submit

November 14, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Survey measure of recovery experiences

    Psychological detachment from work and Relaxation indexes from the Recovery Experience Questionnaire. + Additional single items on experiences of active recovery experiences. Minimum mean score 1, maximum mean score 5 (of each subscale/items). Lower scores indicate worse psychological detachment, worse relaxation and less active recovery experiences respectively. Single items: Do you get sufficient sleep? and Beyond sleep, do you get sufficient recovery? (1 yes, definitely sufficient - 5 no, far from sufficient)

    Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).

  • Survey measure of need for recovery after work

    Short-form versions of the Need For Recovery Scale, in total 5 items about work-induced fatigue. Minimum score 1, maximum score 5. Higher scores indicate a higher need for recovery.

    Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).

  • Survey measure of insomnia symptoms

    Insomnia Severity Index (ISI) which consists of 7 questions related to sleep. The total score is summarised with a minimum score 0, maximum score 28. Higher scores indicate more insomnia symptoms/sleep problems.

    Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).

  • Diary measure of recovery experiences during work and off-work time

    Single items measured in diary study. During work today, I had time for reflection, I experienced periods of extreme fatigue, I could take breaks when needed, I had a good variety in work tasks, shift hand-overs worked out well, I detached from work when leaving. And Today during free-time, I did relaxing things, I did things that gave me energy, I took time for leisure, I had a break from the demands at work, I distanced myself from work, I was not disturbed by work-related questions. Rated from 1 = do not agree - 5 = totally agree.

    7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).

  • Sleep (objective measure)

    Actigraphy (wristband). Measuring of movements during sleep through a sensitive accelerometer. Preprogrammed algorithms make it possible to classify if the participant has slept or not. Example of parameters that can be estimated: Actual sleep time: The total time spent in sleep according to the epoch-by-epoch wake/sleep categorisation. Actual sleep %: Actual sleep time expressed as a percentage of the assumed sleep time. Sleep fragmentation: The sum of the "Mobile time (%)" and the "Immobile bouts \<=1min (%)". This is an indication of the degree of fragmentation

    7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).

Secondary Outcomes (8)

  • Survey measure of general health

    Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).

  • Survey measure of somatic symptom burden

    Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).

  • Survey measure of burnout symptoms

    Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).

  • Survey measure of cognition and work performance

    Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).

  • Survey measure of intention to leave work

    Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).

  • +3 more secondary outcomes

Other Outcomes (1)

  • Negative effects/events of intervention

    Post-intervention (approx. 1 month after managers 5th intervention programme session) and follow-up (1 year after baseline measurement).

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in this arm includes employees of managers in the intervention group (that are participating in the intervention programme).

Behavioral: Leadership for recovery

Wait-list control group

NO INTERVENTION

Participants in this arm includes employees of managers randomised to the control group (that are not participating in the intervention programme during the study period). Managers randomised to the control group will be offered to participate in the intervention programme after the last follow-up assessment. No further employee assessments will be made after the follow-up.

Interventions

The intervention will be delivered as a group-based programme (6 sessions) to the managers of the included employees. The programme includes educative and reflective parts as well as various strategies promoting both managers' own recovery and the recovery of employees.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Managers:
  • First line manager of nursing or laboratory staff in hospital care
  • Employees:
  • Having a first-line manager who participates in the study

You may not qualify if:

  • Managers:
  • Less than 6 months' work experience as a manager at baseline measurement
  • Less than 50 % employment as a manager
  • Employees:
  • Casual worker
  • Less than 6 months' work experience in profession at baseline measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

RECRUITING

Karolinska Universitetssjukhuset

Stockholm, Sweden

RECRUITING

Related Publications (7)

  • Dahlgren A, Tucker P, Epstein M, Gustavsson P, Soderstrom M. Randomised control trial of a proactive intervention supporting recovery in relation to stress and irregular work hours: effects on sleep, burn-out, fatigue and somatic symptoms. Occup Environ Med. 2022 Jul;79(7):460-468. doi: 10.1136/oemed-2021-107789. Epub 2022 Jan 24.

    PMID: 35074887BACKGROUND
  • Dellve L, Eriksson A. Health-Promoting Managerial Work: A Theoretical Framework for a Leadership Program that Supports Knowledge and Capability to Craft Sustainable Work Practices in Daily Practice and During Organizational Change. Societies. 2017;7(2):12.

    BACKGROUND
  • Eriksson A, Dellve L. Learning Processes as Key for Success in Workplace Health Promotion Interventions in Health Care. Front Public Health. 2020 Nov 10;8:576693. doi: 10.3389/fpubh.2020.576693. eCollection 2020.

    PMID: 33304874BACKGROUND
  • Geurts SA, Sonnentag S. Recovery as an explanatory mechanism in the relation between acute stress reactions and chronic health impairment. Scand J Work Environ Health. 2006 Dec;32(6):482-92. doi: 10.5271/sjweh.1053.

    PMID: 17173204BACKGROUND
  • Kecklund G, Axelsson J. Health consequences of shift work and insufficient sleep. BMJ. 2016 Nov 1;355:i5210. doi: 10.1136/bmj.i5210.

    PMID: 27803010BACKGROUND
  • Skakon J, Nielsen K, Borg V, Guzman J. Are leaders' well-being, behaviours and style associated with the affective well-being of their employees? A systematic review of three decades of research. Work and stress. 2010;24(2):107-39.

    BACKGROUND
  • Sonnentag S. The recovery paradox: Portraying the complex interplay between job stressors, lack of recovery, and poor well-being. Research in organizational behavior. 2018;38:169-85.

    BACKGROUND

MeSH Terms

Conditions

Burnout, PsychologicalOccupational StressSleep Initiation and Maintenance DisordersFatigue

Interventions

LeadershipSalvage Therapy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personnel ManagementOrganization and AdministrationHealth Services AdministrationTherapeutics

Study Officials

  • Anna Dahlgren, Docent

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Dahlgren, Docent

CONTACT

Majken Epstein, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docent

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

June 13, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Individual participant data from this study fall under Swedish and European Union data protection and privacy legislation and can therefore not be share in their entirety. Reasonable requests may be directed to the corresponding author, and will be considered on a case-by-case basis

Locations