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

Medizinische Hochschule Brandenburg Theodor Fontane

Status: Enrolling

Conditions: Mental Disorder; Engagement, Patient; Acceptability of Health Care; Nurse's Role

Treatments: Behavioral: Support from Digital Navigators to Patients; Behavioral: Support from Digital Navigators to Treatment Team; Behavioral: Training for Digital Navigators

Study type: Interventional

Funder types: Other

Identifiers

NCT06575582

00034327

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

Exploratory preliminary study

No Intervention group

Description:

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).

Training

Experimental group

Description:

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).

Treatment:

Behavioral: Training for Digital Navigators

Treatment team and patient support

Experimental group

Description:

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).

Treatment:

Behavioral: Support from Digital Navigators to Treatment Team

Behavioral: Support from Digital Navigators to Patients