NCT03648593

Brief Summary

A randomized intervention study to promote work recovery and work ability among micro-entrepreneurs. The main aim is to investigate if the use of Recovery! -application results in better work recovery and work ability than no treatment for micro-entrepreneurs. The plan of action of the study merges: 1) the contents that are based on the needs of the target population and evidence from research on work related and health behaviour enhancing work recovery, 2) theoretical framework for the counselling, 3) counselling methods including behaviour change techniques, and 4) tailoring the content and counselling according to trans theoretical change model and physical work demands. The intervention is delivered through native mobile application designed by using the abovementioned methodology. Data are collected by repeated internet-based questionnaires (at baseline, 2 and 6 months from the beginning of the intervention) and from the use of mobile application. Furthermore, randomly selected persons in two groups (20-30 persons in each) are interviewed. Process evaluation is conducted to detect the mechanisms of change and to study why the program succeeded or failed.

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
1,256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

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

Study Start

First participant enrolled

October 18, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

May 24, 2018

Last Update Submit

August 24, 2018

Conditions

Work AbilityWork-Related ConditionHealth BehaviorIntervention

Keywords

microenterpreneurwork abilitywork recoverynative mobile apphealth behaviourworkstresswork performance

Outcome Measures

Primary Outcomes (2)

  • change from baseline in need for recovery scale at 6 months

    need for recovery scale measures early symptoms of fatigue

    change from baseline in need for recovery scale at 6 months

  • change from baseline in perceived work ability at 6 months. One item of work ability index

    to rate their work ability on a scale of 0 to 10, ten being their lifetime best work ability

    change from baseline in perceived work ability at 6 months

Secondary Outcomes (8)

  • change from baseline in 3-item version of the Utrecht Work Engagement Scale at 6 months

    change from baseline in 3-item version of the Utrecht Work Engagement Scale at 6 months

  • Change from baseline in Recovery Experiences Questionnaire at 6 months

    change from baseline in Recovery Experiences at 6 months

  • World health organization Health and work performance questionnaire

    change from baseline in work performance at 6 months

  • sleep deprivation questions

    change from baseline in sleep deprivation at 6 months

  • Frequency of insomnia symptoms

    change from baseline in insomnia symptoms at 6 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • dose of intervention

    from baseline until 2 months

Study Arms (2)

behavioral

EXPERIMENTAL

work recovery intervention

Behavioral: work recovery intervention

waiting list control

EXPERIMENTAL

work recovery intervention after 6 months

Behavioral: waiting list control

Interventions

work recovery interventionBEHAVIORAL

Recover! app: one hour weekly for two months

behavioral
waiting list controlBEHAVIORAL

no treatment during 6 months,then Recover! app

waiting list control

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Finnish-speaking micro-entrepreneurs (those with enterprise of 1-9 employees),
  • company is located in Finland.
  • work full-time as entrepreneurs,
  • understand Finnish,
  • use an Android phone.

You may not qualify if:

  • not full-time entrepreneurs
  • on sick leave
  • absent from work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Institute of Occupational Health

Oulu, 90220, Finland

Location

Related Publications (1)

  • Kekkonen M, Korkiakangas E, Laitinen J, Oinas-Kukkonen H. Factors Reducing the Use of a Persuasive mHealth App and How to Mitigate Them: Thematic Analysis. JMIR Hum Factors. 2023 Jun 26;10:e40579. doi: 10.2196/40579.

    PMID: 37358883DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jaana Laitinen, PhD, Docent

    Chief Specialist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: randomized intervention trial with waiting list control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Specialist, Principal Investigator, PhD,

Study Record Dates

First Submitted

May 24, 2018

First Posted

August 27, 2018

Study Start

October 18, 2017

Primary Completion

August 30, 2018

Study Completion

March 31, 2019

Last Updated

August 27, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)