Digital Navigators for Acceptance and Competence Development with Mental Health Apps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 6
- 主要终点
- Digital health literacy (focus: digital information retrieval skills)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Digital health literacy (focus: digital information retrieval skills)
时间窗: Before (T0) and after completion of the 12-week intervention (T1)
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.
Digital health literacy (focus: digital interactive skills)
时间窗: Before (T0) and after completion of the 12-week intervention (T1)
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.
Acceptance towards Digital Navigators
时间窗: Before the intervention (T0)
Qualitative questions using semi-structured interviews
Expectations towards Digital Navigators
时间窗: Before the intervention (T0)
Qualitative questions using focus groups
次要结局
- 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))
- Digital competence(Before (T0) and after completion of the 12-week intervention (T1))
- Willingness and competence to change(Before (T0) and after completion of the 12-week intervention (T1))
- Psychological Health of Patients (depressive symptoms; clinician-administered)(Before (T0) and 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))
- Psychological Health of Patients (depressive symptoms; self-report)(Before (T0) and after completion of the 12-week intervention (T1))
- Psychological Health of Patients (anxiety)(Before (T0) and after completion of the 12-week intervention (T1))
- Psychological Health of Patients (insomnia)(Before (T0) and after completion of the 12-week intervention (T1))
- Use of Digital Health Applications and the effects of counseling and support by Digital Navigators(After completion of the 12-week intervention (T1))
- Identification of implementation barriers to the introduction of digital navigators(After completion of the 12-week intervention (T1))
研究者
Laura Uchtmann
M.Sc. Laura Uchtmann
Medizinische Hochschule Brandenburg Theodor Fontane