NCT06575582

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

August 22, 2024

Last Update Submit

August 29, 2024

Conditions

Acceptability of Health CareEngagement, PatientNurse's RoleMental Disorder

Keywords

digital healthehealthmhealthmental healthhealth literacy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (13)

  • Willingness and competence to change

    Before (T0) and after completion of the 12-week intervention (T1)

  • Digital competence

    Before (T0) and after completion of the 12-week intervention (T1)

  • Technical competence

    Before (T0) and after completion of the 12-week intervention (T1)

  • Psychological Health of Patients (level of functioning)

    After completion of the 12-week intervention (T1)

  • Psychological Health of Patients (symptom severity, treatment response and the efficacy of treatment)

    Before (T0) and after completion of the 12-week intervention (T1)

  • +8 more secondary outcomes

Study Arms (3)

Exploratory preliminary study

NO INTERVENTION

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

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

Treatment team and patient support

EXPERIMENTAL

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 TeamBehavioral: Support from Digital Navigators to Patients

Interventions

Support from Digital Navigators to Treatment TeamBEHAVIORAL

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).

Treatment team and patient support
Support from Digital Navigators to PatientsBEHAVIORAL

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.

Treatment team and patient support
Training for Digital NavigatorsBEHAVIORAL

The training takes place in the six study centers and is preferably aimed at medical assistants.

Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Praxis Brandenburg an der Havel

Brandenburg, Brandenburg, 14776, Germany

RECRUITING

Praxis Eberswalde

Eberswalde, Brandenburg, 16225, Germany

RECRUITING

Psychiatrische Institutsambulanz (PIA) Fürstenwalde

Fürstenwalde, Brandenburg, 15517, Germany

RECRUITING

Praxis Fürstenwalde

Fürstenwalde, Brandenburg, 15518, Germany

RECRUITING

Psychiatrische Institutsambulanz (PIA) Rüdersdorf

Rüdersdorf, Brandenburg, 15562, Germany

RECRUITING

Psychiatrische Institutsambulanz (PIA) Strausberg

Strausberg, Brandenburg, 15344, Germany

RECRUITING

Related Publications (1)

  • Schwarz J, Chen K, Dashti H, Heinze M, Schonbeck J, Schubert D, Senst B, Speck J, Torous J, Wolff J, Uchtmann L, Meier-Diedrich E. Piloting Digital Navigators to Promote Acceptance and Engagement With Digital Mental Health Apps in German Outpatient Care: Protocol for a Multicenter, Single-Group, Observational, Mixed Methods Interventional Study (DigiNavi). JMIR Res Protoc. 2025 Sep 25;14:e67655. doi: 10.2196/67655.

    PMID: 40996088DERIVED

Related Links

MeSH Terms

Conditions

Patient Acceptance of Health CarePatient ParticipationMental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPersonal Satisfaction

Study Officials

  • Martin Heinze, Prof

    Medizinische Hochschule Brandenburg Theodor Fontane

    STUDY CHAIR

Central Study Contacts

Julian Schwarz, MD

CONTACT

+49 (0) 33638 83501Julian.Schwarz@mhb-fontane.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: The use of digital navigators in multi-professional treatment teams is a complex intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc. Laura Uchtmann

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 28, 2024

Study Start

July 15, 2024

Primary Completion

May 31, 2025

Study Completion

July 14, 2025

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

DE(6)