Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04695002
Status:
TERMINATED
Last Update Posted:
2022-11-04
First Post:
2020-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can a Digital Tooll Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation?
Sponsor:
Region MidtJylland Denmark
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Too few participants enrolled due to COVID19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: