Digital Navigators for Acceptance and Competence Development with Mental Health Apps (DigiNavi)

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 (e.g. 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.

Study Overview

• Status: Recruiting
• Conditions: Engagement, Patient; Mental Disorder; Nurse's Role; Acceptability of Health Care
• Intervention / Treatment: Behavioral: Training for Digital Navigators; Behavioral: Support from Digital Navigators to Treatment Team; Behavioral: Support from Digital Navigators to Patients

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 DiGAnavigator.de 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 Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julian Schwarz, MD; Phone Number: +49 (0) 33638 83501; Email: Julian.Schwarz@mhb-fontane.de

Study Locations

• Germany
  • Brandenburg
    • Brandenburg an der Havel, Brandenburg, Germany, 14776
      • Recruiting
      • Praxis Brandenburg an der Havel
      • Contact: Julian Schwarz, MD; Phone Number: +49 (0) 33638 83501; Email: Julian.Schwarz@mhb-fontane.de
    • Eberswalde, Brandenburg, Germany, 16225
      • Recruiting
      • Praxis Eberswalde
      • Contact: Julian Schwarz, MD; Phone Number: +49 (0) 33638 83501; Email: Julian.Schwarz@mhb-fontane.de
    • Fürstenwalde, Brandenburg, Germany, 15517
      • Recruiting
      • Psychiatrische Institutsambulanz (PIA) Fürstenwalde
      • Contact: Julian Schwarz, MD; Phone Number: +49 (0) 33638 83501; Email: Julian.Schwarz@mhb-fontane.de
    • Fürstenwalde, Brandenburg, Germany, 15518
      • Recruiting
      • Praxis Fürstenwalde
      • Contact: Julian Schwarz, MD; Phone Number: +49 (0) 33638 83501; Email: Julian.Schwarz@mhb-fontane.de
    • Rüdersdorf, Brandenburg, Germany, 15562
      • Recruiting
      • Psychiatrische Institutsambulanz (PIA) Rüdersdorf
      • Contact: Julian Schwarz, MD; Phone Number: +49 (0) 33638 83501; Email: Julian.Schwarz@mhb-fontane.de
    • Strausberg, Brandenburg, Germany, 15344
      • Recruiting
      • Psychiatrische Institutsambulanz (PIA) Strausberg
      • Contact: Julian Schwarz, MD; Phone Number: +49 (0) 33638 83501; Email: Julian.Schwarz@mhb-fontane.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Main diagnosis according to ICD 10 F00-F69, F80-F99
• Capacity to consent is given
• Sufficient language skills for an interview in German
• Participants have access to modern digital hardware (smartphone)
• Basic knowledge of how to operate a smartphone

Exclusion Criteria:

• Acute danger to self or others
• Patients have received prompt (<= 3 weeks) qualified psychiatric or psychotherapeutic treatment
• Severe organic brain diseases with cognitive deficits
• Intellectual disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Exploratory preliminary study; General practitioners (n = 10), outpatient psychiatrists and psychologists (n = 10) and their patients (n = 20) will be involved. First, partly structured interviews will be conducted with the general practitioners and the psychiatric/psychological professionals as well as the patients they treat in order to record their perspectives on digital health services and the role of digital navigators. In parallel, focus groups will be organized with all three main groups to understand their opinions, concerns and expectations regarding the use of digital health applications and digital navigators. The data collection for the preliminary study extends over a period of 3 months (October - December 2024).
Experimental: Training; Staff members (n = 6) of participating study cites will be trained to become Digital Navigators. The recruitment and training of the digital navigators will take place over a period of 4 months (October 2024 to January 2025).	Behavioral: Training for Digital Navigators; The training takes place in the six study centers and is preferably aimed at medical assistants.
Experimental: Treatment team and patient support; The Digital Navigators support the treatment teams in the study centers in the selection and integration of suitable apps and digital health applications (DiGAs). The selected patients (n = 48, 8 per center) are accompanied and supported by the trained navigators for 12 weeks to find a suitable app for them and integrate it into their treatment. A total period of 3 months is planned for both the recruitment of patients and the implementation off the intervention (December 2024 to February 2025).	Behavioral: Support from Digital Navigators to Treatment Team; The trained professionals (the Digital Navigators) support the treatment teams in the study centers in the selection and integration of suitable apps and digital health applications (DiGAs).; Behavioral: Support from Digital Navigators to Patients; The trained professionals (the Digital Navigators) accompany and support the selected patients to find a suitable app for them and integrate it into their treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital health literacy (focus: digital information retrieval skills)	Using the self-report rating inventory eHealth Literacy Scale (eHeals). Total score ranges from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.	Before (T0) and after completion of the 12-week intervention (T1)
Digital health literacy (focus: digital interactive skills)	Using a performance-based rating inventory Digital Health Literacy Index (DHLI). Total score ranges from 0 to 7, with higher scores representing a greater ability to operate digital devices and read and write in web-based modes.	Before (T0) and after completion of the 12-week intervention (T1)
Acceptance towards Digital Navigators	Qualitative questions using semi-structured interviews	Before the intervention (T0)
Expectations towards Digital Navigators	Qualitative questions using focus groups	Before the intervention (T0)
Expectations towards Digital Navigators	Qualitative questions using semi-structured interviews	Before the intervention (T0)
Acceptance towards Digital Navigators	Qualitative questions using focus groups	Before the intervention (T0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Willingness and competence to change	Using the self-report rating inventory "Readiness for Change". Total score ranges from 0 to 172, with higher scores representing higher self-perceived willingness and competence to change.	Before (T0) and after completion of the 12-week intervention (T1)
Digital competence	Using the self-report rating inventory ICT Self-Concept Scale. Total score ranges from 25 to 150, with higher scores representing higher self-perceived digital competence.	Before (T0) and after completion of the 12-week intervention (T1)
Technical competence	Using the self-report rating inventory "Kurzskala Technikbereitschaft" (TB, technology commitment). Total score ranges from 12 to 60, with higher scores representing higher self-perceived technical competence.	Before (T0) and after completion of the 12-week intervention (T1)
Psychological Health of Patients (level of functioning)	Using the self-report rating inventory Global Assessment of Functioning (GAF). Total score ranging from 0-100, with a higher score indicating a higher level of functioning.	After completion of the 12-week intervention (T1)
Psychological Health of Patients (symptom severity, treatment response and the efficacy of treatment)	Using the self-report rating inventory Clinical Global Impression (CGI); Measuring three dimensions: severity of illness (score 1-7, with a higher score indicating a more severe illness), global improvement (score 1-7, with a higher score indicating a worsening of symptoms) and efficacy (measured with 4×4 rating scale (ranging from 01 - 16) that assesses the therapeutic effect of treatment and associated side effects; e.g. 01 = no side effects; vast improvement; 16 = severe side effects; unchanged or worse condition)	Before (T0) and after completion of the 12-week intervention (T1)
Psychological Health of Patients (depressive symptoms; self-report)	Using the self-report rating inventory Beck's Depression Inventory (BDI); Total score 0-63, with higher scores representing more severe depressive symptoms.	Before (T0) and after completion of the 12-week intervention (T1)
Psychological Health of Patients (depressive symptoms; clinician-administered)	Using the clinician-administered rating inventory Hamilton Depression Scale (HAMD); Total score 0-52, with higher scores representing more severe depressive symptoms.	Before (T0) and after completion of the 12-week intervention (T1)
Psychological Health of Patients (anxiety)	Using the clinician-administered rating inventory Hamilton Anxiety Scale (HAMA); Total score 0-56, with higher scores representing more severe anxiety symptoms.	Before (T0) and after completion of the 12-week intervention (T1)
Psychological Health of Patients (insomnia)	Using the self-report rating inventory Insomnia Severity Index (ISI); Total score 0-28, with higher scores representing more severe insomia symptoms.	Before (T0) and after completion of the 12-week intervention (T1)
Identification of implementation barriers to the introduction of digital navigators	Qualitative questions using semi-structured interviews	After completion of the 12-week intervention (T1)
Identification of implementation barriers to the introduction of digital navigators	Qualitative questions using focus groups	After completion of the 12-week intervention (T1)
Use of Digital Health Applications and the effects of counseling and support by Digital Navigators	Qualitative questions using semi-structured interviews	After completion of the 12-week intervention (T1)
Use of Digital Health Applications and the effects of counseling and support by Digital Navigators	Qualitative questions using focus groups	After completion of the 12-week intervention (T1)

Collaborators and Investigators

• Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
• Collaborators: Harvard Medical School (HMS and HSDM); Hannover Medical School
• Investigators: Study Chair: Martin Heinze, Prof, Medizinische Hochschule Brandenburg Theodor Fontane

Publications and helpful links

Helpful Links

• Information about study from German Federal Ministry of Health (in German)
• Official DigiNavi Website

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): July 14, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: mental health; health literacy; digital health; mhealth; ehealth
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 00034327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have decided not to make the individual participant data (IPD) publicly available in order to ensure the highest level of data protection and confidentiality. Although all data will be properly anonymized, we want to ensure that no conclusions can be drawn about individual participants, not even indirectly. The protection of study participants' personal data is a top priority for us. Therefore, for ethical and data protection reasons, it is more responsible not to make the IPD publicly accessible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No