Clinical trial NCT04695002: Can a Digital Tooll Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation?
Official title: Does the Application of a Digital Tool With Real-time, Self-reported Data Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation? A Mixed Methods Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Musculoskeletal Pain
Keywords: Rehabilitation, Vocational
Telemedicine
Lead sponsor: Region MidtJylland Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus County, Denmark
First posted: 2021-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study takes place in a multidisciplinary health care unit in a municipal employment department in Denmark. The study population consists of citizens who referred from the job centre due to limitations in their work ability, as assessed by the case managers, due to musculoskeletal and/or stress-related disorders (the two conditions are often interrelated). In the present study only citizens with a sufficient level of Danish are included, as the MIRA-app only exists in a Danish version. Citizens are between the age of 18 and 68 (i.e, working age), and may be employed, but on prolonged sick leave, or may be unemployed.

Brief summary: The study investigates both the effects and the experienced value of the mobile application, MIRA, which is a combination of an electronic diary, a dialogue tool and a decision support tool. The individual user registers real-time data reported in a mobile application, e.g. pain, sleep, mood, social activities, work-related activities, based on the goals and condition of the individual user. In this study, users are citizens participating in vocational rehabilitation due to long term sick leave.

The purpose of MIRA is to support a positive and trustful relationship between the citizen and the professional, and to enhance user involvement and shared decision making in the course of rehabilitation. This happens through promotion of the citizens knowledge and understanding of their own health condition and increase his or her self-efficacy, i.e. their ability to cope with their health condition at work and in everyday life.

The study uses a combination of quantitative and qualitative methods, analysed both individually and in combination, where findings of the different methods are combined to provide a deeper understanding of the positive and negative effects of using MIRA in vocational rehabilitation.

In this way the study investigates both the effect of applying a digital tool, such as MIRA, on a number of quantifiable measures (using questionnaires), and at the same time the study explores what works for whom and why using qualitative and combined methods. In this way, the study aims to contribute with knowledge in a balanced manner, regarding the pros and cons of using digital tools with real-time self-reported data in rehabilitation.

The study aim will be fulfilled through the following sub-purposes:

1. To investigate the effect of using MIRA in a course of vocational rehabilitation in relation to the citizens' self-efficacy for pain and work and their experience of shared decision-making in the course of rehabilitation.
2. To investigate the citizens' experience with and perception of using a digital tool like MIRA in their course of rehabilitation.
3. To investigate the professionals' experience with and perception of using a digital tool like MIRA in the course of rehabilitation.
4. To investigate the mechanisms of effect of MIRA (i.e. what works for whom and why), through and integrated analysis of the findings of sub-purpose 1-3.


Eligibility criteria: Inclusion Criteria:

* Referred for a course of vocational rehabilitation at a multidisciplinary health care unit at a municipal employment department.
* On sick leave or unemployed due to musculoskeletal or stress-related disorders
* In the working age (18 - 68 years approximately)

Exclusion Criteria:

* On sick leave or unemployed for other reasons, e.g. psychiatric disorders or cancer;
* Under the age of 18 or older than 68 years (approximately)
* Not sufficiently familiar with Danish language to use the MIRA app as intended.

Primary outcomes:
measure: Return-to-work Self-efficacy Scale (RTW-SE)
timeFrame: At baseline and at end of rehabilitation, an average of 8 weeks
Secondary outcomes:
measure: CollaboRATE
timeFrame: At end of rehabilitation, an average of 8 weeks
measure: WHO-5
timeFrame: At baseline and at end of rehabilitation, an average of 8 weeks
Other outcomes:
measure: Usability of MIRA
timeFrame: At the end of rehabilitation, an average of 8 weeks
Locations:
city: Aarhus
country: Denmark
facility: Sociallægeinstitutionen
Study officials:
affiliation: Defactum, Central Denmark Region
name: Nanna Rolving, PhD
role: PRINCIPAL_INVESTIGATOR
References: