Can a Digital Tooll Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation?

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

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.

Study Overview

• Status: Terminated
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Behavioral: Control; Behavioral: MIRA

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Sociallægeinstitutionen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Citizens in the control group participate in the existing course of vocational rehabilitation offered in the municipal employment department, without the use of MIRA app.	Behavioral: Control; Citizens in the control group participate in the standard course of vocational rehabilitation, without the use of MIRA app. Citizens are referred from the jobcenter if the case manager assesses that a health condition limits the citizen's ability to resume work. The typical course of rehabilitation lasts 4-12 weeks, and is managed by a physiotherapist, a psychologist and a physician. Depending on the condition of the citizen, the rehabilitation may be managed by only two of the three professionals. During the course of rehabilitation, the citizen may consult the team with varying frequency. If physical rehabilitation is part of the prescribed rehabilitation, the citizen shows up twice per week for several weeks of supervised exercise, whereas rehabilitation courses where self-management is in focus, only biweekly consultations may be provided. The decisions and planning of contents and duration of the rehabilitation programme is done in collaboration with the citizen.
MIRA group; Citizens in the MIRA group will participate in the existing course of vocational rehabilitation offered in the municipal department. In addition they will be introduced to MIRA at the beginning of the rehabilitation course, and use MIRA throughout the course of rehabilitation.	Behavioral: MIRA; Based on the initial assessment, the citizen and professional agree what outcomes the citizen should report in MIRA. This could be pain, mood, sleep quality, energy level, dependent on the priorities of the citizen. Similarly, different activities are reported, e.g. exercise, social activities, prolonged sitting or work-related tasks. The citizen and the professional agree how often the citizen reports the outcomes and tasks, and the citizen is notified by the MIRA-app when it's time for reporting. The data will be visualized in a graph for the professional in the back-end of the system, making it possible for the citizen and the professional to view the same, real-time reported data. This provides the base for discussing and adjusting the course of rehabilitation as symptoms change over time. At the same time, this increases the citizen's knowledge of how symptoms, mood, sleep and activities all interact, thereby giving them the tools better cope with their health condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return-to-work Self-efficacy Scale (RTW-SE)	The RTW-SE is a 10-item questionnaire measuring the respondent's self-efficacy for coping with their health condition in relation to returning to work. Score ranges from 10-50 points, with 50 points reflecting the highest level of self-efficacy	At baseline and at end of rehabilitation, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CollaboRATE	CollaboRATE is a 3-item questionnaire, measuring to what extent the respondent feels involved in the decision making process in their course of rehabilitation (i.e. shared decision making) on a scale of 0-9 (worst-best). An average score of the three items is calculated	At end of rehabilitation, an average of 8 weeks
WHO-5	WHO5-index is a 5-item generic questionnaire for measuring self-reported quality of life and general well-being. Each item is scored on a scale of 5 (best) to 0 (worst), adding up to a total score of 0-25	At baseline and at end of rehabilitation, an average of 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of MIRA	For participants in the MIRA group 4 questions regarding the usability of MIRA is applied, e.g. the need for technical support in the use of MIRA.	At the end of rehabilitation, an average of 8 weeks

Collaborators and Investigators

• Sponsor: Region MidtJylland Denmark
• Collaborators: Aarhus County, Denmark
• Investigators: Principal Investigator: Nanna Rolving, PhD, Defactum, Central Denmark Region

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Rehabilitation, Vocational
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: A3156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: As the data are owned by the municipality participating in the study, the primary investigator/study official is not allowed to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No