Clinical trial NCT06575582: Digital Navigators for Acceptance and Competence Development with Mental Health Apps
Official title: Digital Navigators for Acceptance and Competence Development with Mental Health Apps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acceptability of Health Care
Engagement, Patient
Nurse's Role
Mental Disorder
Keywords: digital health
ehealth
mhealth
mental health
health literacy
Lead sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Hannover Medical School
First posted: 2024-08-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The use of digital navigators in multi-professional treatment teams is a complex intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 (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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Digital health literacy (focus: digital information retrieval skills)
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Digital health literacy (focus: digital interactive skills)
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Acceptance towards Digital Navigators
timeFrame: Before the intervention (T0)
measure: Expectations towards Digital Navigators
timeFrame: Before the intervention (T0)
measure: Expectations towards Digital Navigators
timeFrame: Before the intervention (T0)
measure: Acceptance towards Digital Navigators
timeFrame: Before the intervention (T0)
Secondary outcomes:
measure: Willingness and competence to change
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Digital competence
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Technical competence
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Psychological Health of Patients (level of functioning)
timeFrame: After completion of the 12-week intervention (T1)
measure: Psychological Health of Patients (symptom severity, treatment response and the efficacy of treatment)
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Psychological Health of Patients (depressive symptoms; self-report)
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Psychological Health of Patients (depressive symptoms; clinician-administered)
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Psychological Health of Patients (anxiety)
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Psychological Health of Patients (insomnia)
timeFrame: Before (T0) and after completion of the 12-week intervention (T1)
measure: Identification of implementation barriers to the introduction of digital navigators
timeFrame: After completion of the 12-week intervention (T1)
measure: Identification of implementation barriers to the introduction of digital navigators
timeFrame: After completion of the 12-week intervention (T1)
measure: Use of Digital Health Applications and the effects of counseling and support by Digital Navigators
timeFrame: After completion of the 12-week intervention (T1)
measure: Use of Digital Health Applications and the effects of counseling and support by Digital Navigators
timeFrame: After completion of the 12-week intervention (T1)
Other outcomes:
Locations:
city: Brandenburg an der Havel
country: Germany
facility: Praxis Brandenburg an der Havel
state: Brandenburg
city: Eberswalde
country: Germany
facility: Praxis Eberswalde
state: Brandenburg
city: Fürstenwalde
country: Germany
facility: Psychiatrische Institutsambulanz (PIA) Fürstenwalde
state: Brandenburg
city: Fürstenwalde
country: Germany
facility: Praxis Fürstenwalde
state: Brandenburg
city: Rüdersdorf
country: Germany
facility: Psychiatrische Institutsambulanz (PIA) Rüdersdorf
state: Brandenburg
city: Strausberg
country: Germany
facility: Psychiatrische Institutsambulanz (PIA) Strausberg
state: Brandenburg
Study officials:
affiliation: Medizinische Hochschule Brandenburg Theodor Fontane
name: Martin Heinze, Prof
role: STUDY_CHAIR
References: