NCT05006976

Brief Summary

The Norwegian Sickness Absence Clinic (NSAC) Nudge Study is a naturalistic randomized controlled multicentre trial which aim is to measure the efficacy of nudging clinicians' attention towards patients' motivation for work, barriers for return to work and work environment challenges, on functional recovery as primary outcome, and health outcomes as secondary outcome. Patients will be recruited in five different NSACs across northern Norway. In total 1100 patients will be randomized to two equal probability treatment arms: 1) NSAC with the nudge, and 2) NSAC without the nudge. The nudge is tailored to the individual patient's needs using survey, and the clinicians are presented with a summary of this patient survey prior to consultations highlighting health problems and challenges as reported by the patient in the survey.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,180

participants targeted

Target at P75+ for not_applicable

Timeline
81mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not 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 Progress41%
Sep 2021Jan 2033

First Submitted

Initial submission to the registry

August 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

September 6, 2021

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2028

Expected
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2033

Last Updated

April 13, 2026

Status Verified

June 1, 2025

Enrollment Period

6.6 years

First QC Date

August 9, 2021

Last Update Submit

April 7, 2026

Conditions

Keywords

Return to workSickness absenceNudgeBarriers for return to workMotivation for workDemand and controlWork/family conflictBullying

Outcome Measures

Primary Outcomes (4)

  • Functional recovery: status, plan and prognosis for employment versus sickness absence

    Clinician report at last consultation of current status, plan and prognosis for patient employment versus sickness absence. Status is current employment versus sickness absence, plan refers to patients own ambition and plans for employment versus sickness absence short term, while prognosis refers to the clinicians assessment of prognosis for employment versus sickness absence in 12 months.

    At last appointment at NSAC (can vary substantially between patients, but generally < 3 months after first appointment at NSAC)

  • Functional recovery: sickness absence self-report

    Employment, sickness absence and application for rehabilitation benefits between Time 0 and Time 2, based on patient self-report.

    Up to 31 months post baseline survey

  • Functional recovery: sickness absence registry data

    Employment, sickness absence and application for rehabilitation benefits during first 365 days post baseline survey, based on registry data.

    12 months post baseline survey

  • Functional recovery: disability benefits

    Employment, sickness absence, rehabilitation benefits and disability benefits during 5-year period post baseline survey, all based on registry data.

    60 months post baseline survey

Secondary Outcomes (15)

  • Mental health

    Up to 31 months post baseline survey

  • Anxiety

    Up to 31 months post baseline survey

  • Depressive symptoms

    Up to 31 months post baseline survey

  • Sleep

    Up to 31 months post baseline survey

  • Health Anxiety

    Up to 31 months post baseline survey

  • +10 more secondary outcomes

Other Outcomes (16)

  • Preventive effect of sickness absence

    Up to 31 months post baseline survey

  • Health economic evaluation: self report

    Up to 31 months post baseline survey

  • Health economic evaluation: labour costs

    12 months post baseline survey

  • +13 more other outcomes

Study Arms (2)

NSAC health only

ACTIVE COMPARATOR

Treatment as usual (TAU) at NSAC, following a digital survey of health problems and the provision of a condensed report of this survey to clinician prior to consultation.

Other: NSAC health only

NSAC health + MBW

EXPERIMENTAL

Treatment as usual (TAU) at NSAC, following a digital survey of health problems as well as Motivation, Barriers for return to work and Work environment (MBW), and the provision of a condensed report of this survey to clinician prior to consultation.

Other: NSAC health + MBW

Interventions

NSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In "NSAC health only", clinicians are provided survey information on potential health problems only.

NSAC health only

NSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In "NSAC health + MBW" clinicians are provided survey information on potential health problems as well as information on motivation for work, barriers for return to work and work environment factors.

NSAC health + MBW

Eligibility Criteria

Age23 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Aged younger than 23 years at time of referral. The NSACs have guidelines that describe eligibility for treatment, and excludes patients that are either too healthy for the measure, too sick for the measure, not relevant diagnosis or otherwise not considered being in the target group for the measure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Helse I Arbeid Nordlandssykehuset

Bodø, Nordland, 8092, Norway

Location

Helse I Arbeid Helgelandssykehuset

Sandnessjøen, Nordland, 8800, Norway

Location

Opptreningssenteret i Finnmark

Alta, Troms Og Finnmark, 9510, Norway

Location

Helse I Arbeid Finnmarkssykehuset

Kirkenes, Troms Og Finnmark, 9915, Norway

Location

Helse I Arbeid Universitetssykehuset Nord-Norge

Tromsø, Troms Og Finnmark, 9019, Norway

Location

Related Publications (3)

  • Myhrer M, Brinchmann B, Trichet L, Aars NA, Mykletun A. Barriers for return to work as an iatrogenic effect of sickness absence: a proposed conceptual framework and questionnaire based on a cross-sectional study. BMC Public Health. 2026 Feb 12. doi: 10.1186/s12889-026-26584-1. Online ahead of print.

  • Bardal I, Aars NAP, Trichet LO, Brandseth OL, Terjesen C, Irgens E, Hansen BO, Kristoffersen A, Hoper A, Jenssen OR, Brinchmann B, Mykletun A. Expanding the Focus on Work Factors in an Outpatient Setting: Does a Nudge of Patients and Clinicians have an Effect on Return-to-Work and Benefits? Findings from the NSAC Nudge Multicentre Randomised Controlled Trial. J Occup Rehabil. 2025 Dec 12. doi: 10.1007/s10926-025-10343-x. Online ahead of print.

  • Aars NA, Bardal I, Brinchmann B, Mykletun A. Naturalistic trial of nudging patients and clinicians in the Norwegian sickness absence clinics: a study protocol for the NSAC Nudge Study. BMJ Open. 2025 Mar 3;15(3):e089758. doi: 10.1136/bmjopen-2024-089758.

MeSH Terms

Conditions

Musculoskeletal DiseasesAnxiety DisordersDepressionFatiguePainOccupational StressBullying

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsOccupational DiseasesStress, PsychologicalAggressionHarassment, Non-SexualSocial Behavior

Study Officials

  • Arnstein Mykletun, PhD

    UiT The Arctic University of Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participant is masked to which questionnaire he/she fills out. The primary outcome is functional recovery, operationalized in the short term as prevention of sickness absence or return to work, and in the long term as employment or disability benefits. To this end, registry data on employment status or qualification for disability benefits is applied. Clinicians (usually the patient's general practitioner) and case managers involved in decisions on medically certified sickness absence and disability benefits are blinded to randomization.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are randomized in equal proportions to fill out either of two different questionnaires, consisting either of 1) health related questions only or 2) health related questions as well as questions concerning motivation for work, barriers for return to work and work environment. In both treatment arms, clinicians receive a summary of patient survey information on mental health and musculoskeletal pain. In the intervention arm, clinicians are nudged to have particular attention towards motivation for work, barriers for return to work and work environment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 16, 2021

Study Start

September 6, 2021

Primary Completion (Estimated)

April 12, 2028

Study Completion (Estimated)

January 12, 2033

Last Updated

April 13, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

There are no plans to share individual patient data with other researchers. At the stage of analyses, associated researchers will be provided with an anonymized data set including all relevant data to answer the research questions.

Locations