Implementation of a digital nurse to improve the use of digital health applications for older people with depressive disorders (DiGA4Aged) - A randomized proof of concept study.
Organizational Data
- DRKS-ID:
- DRKS00033535
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2024-02-02
- Last update in DRKS:
- 2024-02-02
- Registration type:
- Prospective
Acronym/abbreviation of the study
DiGA4Aged
URL of the study
No Entry
Brief summary in lay language
DiGA4Aged aims to increase the usage rate of digital health applications (DiGA) in older patients with mild to moderate depression. It has already been shown that DiGAs can be an effective support in psychotherapy, especially as a bridging measure in cases of long waiting times. Nevertheless, older people use DiGAs less frequently than younger people. The aim of the study is to examine whether the usage rate of a registered app for depression treatment can be improved in older patients by providing support in the form of a "digital nurse". The support is to be offered over a period of 8 weeks after prescription of the DiGA. After a further 8 weeks of follow-up, the utilization rate will be compared with a group of patients who did not receive support in the form of a digital nurse.
Brief summary in scientific language
Digital health applications (DiGAs) are an inexpensive and effective supplement to analog therapies. The effectiveness of DiGAs for treating depression has already been proven in several studies. It has been shown that it is mainly younger people with a higher level of education who use DiGAs. However, older people who have been supported in the installation and use of DiGAs are more adherent, which increases their effectiveness. The aim of the DiGA4Aged study is to investigate to what extent the use rate of a DiGA for depression treatment in older patients can be increased by support in the form of a "digital nurse". In a randomized controlled trial design, the intervention arm receives support in the form of telephone, on-site and email contacts over a period of 8 weeks after the DiGA has been prescribed. The control arm only receives information from the treating physician and information on the use of the DiGA. After the intervention phase and a further 8 weeks after the end of the intervention, the usage rates of the groups will be compared and secondary outcomes analyzed.
Health condition or problem studied
- ICD10:
- F32.0 - Mild depressive episode
- ICD10:
- F33.0 - Recurrent depressive disorder, current episode mild
- ICD10:
- F32.1 - Moderate depressive episode
- ICD10:
- F33.1 - Recurrent depressive disorder, current episode moderate
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Participants in the intervention group receive after inclusion a) The prescription of a depression-specific DiGA b) A brief explanation of the DiGA using the manufacturer's information videos. c) 8 weeks of support and "digital coaching" by a digital nurse Regarding a) The DiGA list of the BfArM currently contains two DiGAs that are approved for the treatment of people with depressive disorders. While "Selfapys online course for depression" (Krämer et al. 2022) is approved for use in mild and moderate depressive disorders, "deprexis" (Berger et al. 2018; Twomey et al. 2017) is approved for mild, moderate and severe depressive disorders; both DiGAs are permanently approved. Therapeutically, both DiGAs use behavioral interventions and approaches, training and self-awareness and regulation exercises, which the individual goes through independently via a digital portal or an app. The programs are designed to be interactive and adapt to the user's reactions and interactions (e.g., interactive dialogue). Motivational emails are sent for support (Deprexis) or basic email contact is offered with psychological advisors from the manufacturers (Selfapy). The recommended periods of use are comparable and are around 90 days or 12 weeks. A weekly usage period of 1-2 hours is recommended. The DiGA can be prescribed by doctors or psychotherapists. A pre-pilot test will determine which of the two DiGAs is easier to use. A prescription is issued for this purpose (sample 16). Regarding b) Patients receive information on the use of the DiGA with the DiGA manufacturer's information material using the manufacturer's own information videos. Participants in the control arm will not receive any further support over the intervention period of 8 weeks. Regarding c) The intervention group also receives the offer of regular individual support from a digital nurse, who accompanies and supervises the process of applying to the health insurance companies, the installation/navigation to the website up to the first use of the DiGA for up to 8 weeks, depending on the patient's needs. The trained Digital Nurse supports the individual patient with the installation, application and actual use of the DiGA for up to 8 weeks or until the first use of the DiGA, whichever comes first (intervention phase). This means that the digital nurse's support ends when the patient is able to start using the DiGA. However, the digital nurse remains available for problems and questions regarding DiGA use. During the intervention phase, there is no specification regarding the number, duration and type of contacts (telephone, online, face-to-face). The type of contacts, number and total support time for each participant are documented and evaluated, and the digital nurses are trained in particular in the prescription process and in contacting the DiGA manufacturer and the health insurance company. The digital nurses are also trained in the installation and use of the DiGA. Advice for elderly and depressed patients will also be part of the digital nurses' training. A guideline will be developed that defines the counseling process and care options. Checklists will be used to ensure compliance with the guidelines.
- Arm 2:
- Arm 2 (control group / TAU): Participants in the intervention group receive after inclusion: a) The prescription of a depression-specific DiGA b) A brief explanation of the DiGA using the manufacturer's information videos. Regarding a) The DiGA list of the BfArM currently contains two DiGAs that are approved for the treatment of people with depressive disorders. While "Selfapys online course for depression" (Krämer et al. 2022) is approved for use in mild and moderate depressive disorders, "deprexis" (Berger et al. 2018; Twomey et al. 2017) is approved for mild, moderate and severe depressive disorders; both DiGAs are permanently approved. Therapeutically, both DiGAs use behavioral interventions and approaches, training and self-awareness and regulation exercises, which the individual goes through independently via a digital portal or an app. The programs are designed to be interactive and adapt to the user's reactions and interactions (e.g., interactive dialogue). Motivational emails are sent for support (Deprexis) or basic email contact is offered with psychological advisors from the manufacturers (Selfapy). The recommended periods of use are comparable and are around 90 days or 12 weeks. A weekly usage period of 1-2 hours is recommended. The DiGA can be prescribed by doctors or psychotherapists. A pre-pilot test will determine which of the two DiGAs is easier to use. A prescription is issued for this purpose (sample 16). Regarding b) Patients receive information on the use of the DiGA with the DiGA manufacturer's information material using the manufacturer's own information videos. Participants in the control arm receive no further support over the intervention period of 8 weeks.
Endpoints
- Primary outcome:
- Is the patient using the DiGA after 8 weeks (T1)? (yes/no). The primary endpoint is assessed by telephone interviews or private contact (patient self-report).
- Secondary outcome:
- 1) Depressive symptoms (PHQ-9) (T0, T1, T2) 2) Treatment of depression through medication and other therapies (T0, T1, T2) 3) Usability of the DiGA (SUS, UEQ) (T1 and T2)
Study Design
- Purpose:
- Health care system
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Centralized online randomization by REDCap
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- Centralized online randomization by REDCap
- Who is blinded:
-
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Klinik für Psychosomatische Medizin und Psychotherapie, LWL-Universitätsklinikum der Ruhr-Universität Bochum Bochum
- University medical center Klinik für Psychiatrie, Psychotherapie und Präventionsmedizin, LWL-Universitätsklinikum der Ruhr-Universität Bochum Bochum
- University medical center Klinik für Altersmedizin und Frührehabilitation, Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum Herne
- University medical center Hausarztpraxen in Kooperation mit der Abteilung für Allgemeinmedizin (AM RUB), Ruhr-Universität Bochum, Bochum
Recruitment period and number of participants
- Planned study start date:
- 2024-05-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 200
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 60 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Mild to moderate depressive disorder according to ICD-10 codes F32.0, F32.1, F33.0, F33.1; access to a digital device (desktop computer, tablet, smartphone) that allows the use of DiGA; consent to participate in all parts of the study and availability for the duration of the study; signed informed consent form
Exclusion Criteria
1) Inability to give consent 2) Acute suicidal tendencies 3) Severe auditory and/or visual impairment 4) Lack of German language skills 5) Presence of dementia 6) Presence of bipolar disorder or schizophrenia 7) Advanced incurable illness 8) Participation in another treatment or intervention study 9) Current use of DiGA for depression
Addresses
Primary Sponsor
- Address:
- Ruhr-Universität BochumUniv.-Prof. Dr. med. MPH Horst Christian VollmarUniversitätsstr. 15044801 BochumGermany
- Telephone:
- +49 234 32 27127
- Fax:
- +49 234 32 14364
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.amrub.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Ruhr-Universität Bochum Medizinische Informatik, Biometrie und EpidemiologieCO-PI Prof. Dr. Nina TimmesfeldUniversitätsstr. 10544789 BochumGermany
- Telephone:
- +49 234/32-27790
- Fax:
- +40 0234 32 14325
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- LWL-Universitätsklinikum Bochum, Klinik für Psychosomatische Medizin und Psychotherapie, Ruhr-Universität BochumDr. med. Jan Dieris-HircheAlexandrinenstraße 1-344791 BochumGermany
- Telephone:
- +49 234 5077 3135
- Fax:
- +49 234 5077 3759
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- LWL-Universitätsklinikum Bochum, Klinik für Psychosomatische Medizin und Psychotherapie, Ruhr-Universität BochumDr. med. Jan Dieris-HircheAlexandrinenstraße 1-344791 BochumGermany
- Telephone:
- +49 234 5077 3135
- Fax:
- +49 234 5077 3759
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- InnovationsFoRUM der Medizinischen Fakultät der Ruhr-Universität BochumUniversitätsstr. 15044801 BochumGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität BochumGesundheitscampus 3344801 BochumGermany
- Telephone:
- +49-234-79816555
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ruhr-uni-bochum.de/ethik/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-08-01
- Ethics committee number:
- 23-7901
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-11-17
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00032931 - Erfassung der Erfahrungen und Kenntnisse im Umgang mit digitaler Kommunikationstechnologien und Bereitschaft zur Anwendung einer digitalen Gesundheitsanwendung (DiGA) bei geriatrischen Patienten (Screening Studie)
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry