Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575582
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Digital Navigators for Acceptance and Competence Development with Mental Health Apps
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Digital Navigators for Acceptance and Competence Development with Mental Health Apps
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DigiNavi
Brief Summary:
The goal of this clinical trial is to learn if and how so called Digital Navigators DN can help general practitioners outpatient psychiatrists and psychologists as well as their treated patients to use digital mental health apps DiGAs and integrate it into their treatment The main questions it aims to answer are
What are the chances and implementation barriers of DN
What are the acceptance and expectations towards DN
Do DN affect the psychological health of patients
Do DN affect the digital health literacy and technical competence of participants
Employees of medical teams eg medical assistants receive training to become a DN Afterwards patients are accompanied and supported by the DN for 12 weeks to select and use a suitable app for their mental disorder
What are the chances and implementation barriers of DN
What are the acceptance and expectations towards DN
Do DN affect the psychological health of patients
Do DN affect the digital health literacy and technical competence of participants
Employees of medical teams eg medical assistants receive training to become a DN Afterwards patients are accompanied and supported by the DN for 12 weeks to select and use a suitable app for their mental disorder
Detailed Description:
The study aims to promote the use of digital health applications DiGAs to improve mental health and provide timely treatment for underserved populations Currently DiGAs are only used by a small proportion of patients and practitioners in Germany In order to solve this care problem employees of medical teams such as medical assistants are to be trained as so-called digital navigators These digital navigators support stakeholders in the selection and use of mental health apps impart the necessary digital skills improve adherence and relieve the burden on those providing treatment
As part of the pilot project digital navigators will be implemented as an example in GP and outpatient psychiatric care in a rural region of Brandenburg Firstly a preliminary study will be conducted to determine the acceptance and expectations of the digital navigators using interviews and focus groups The researchers then complete a training program at Harvard Medical School and adapt the Harvard Digital Navigator Training to the German framework conditions This adaptation process is supported by discussion groups with patients and practitioners
In the next step medical assistants in six study centres will receive the adapted training A central tool available to them is the DiGAnavigatorde website a guide for DiGAs The digital navigators help with the integration of DiGAs into the treatment of 48 patients with mental illnesses and accompany them over a period of 12 weeks
Finally the implementation will be evaluated The evaluation analyses the implementation hurdles and the effects on the eHealth literacy of patients and professionals The eHealth Literacy Scale eHeals and the Digital Health Literacy Index DHLI will be used for this purpose An accompanying process evaluation analyses the acceptance effects and implementation barriers of the digital navigators In addition both patients and staff are surveyed regarding their digital and technical skills as well as their willingness and ability to change before and after the intervention Furthermore the severity of the patients illness will be recorded and compared before and after the intervention using validated scales To ensure sustainable implementation the long-term aim is to provide accredited training to become a digital navigator
As part of the pilot project digital navigators will be implemented as an example in GP and outpatient psychiatric care in a rural region of Brandenburg Firstly a preliminary study will be conducted to determine the acceptance and expectations of the digital navigators using interviews and focus groups The researchers then complete a training program at Harvard Medical School and adapt the Harvard Digital Navigator Training to the German framework conditions This adaptation process is supported by discussion groups with patients and practitioners
In the next step medical assistants in six study centres will receive the adapted training A central tool available to them is the DiGAnavigatorde website a guide for DiGAs The digital navigators help with the integration of DiGAs into the treatment of 48 patients with mental illnesses and accompany them over a period of 12 weeks
Finally the implementation will be evaluated The evaluation analyses the implementation hurdles and the effects on the eHealth literacy of patients and professionals The eHealth Literacy Scale eHeals and the Digital Health Literacy Index DHLI will be used for this purpose An accompanying process evaluation analyses the acceptance effects and implementation barriers of the digital navigators In addition both patients and staff are surveyed regarding their digital and technical skills as well as their willingness and ability to change before and after the intervention Furthermore the severity of the patients illness will be recorded and compared before and after the intervention using validated scales To ensure sustainable implementation the long-term aim is to provide accredited training to become a digital navigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None