Digital Coaching of Individual Stress Coping Mechnisms Via Sensor and App For Care Workers
Organizational Data
- DRKS-ID:
- DRKS00024605
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-07-12
- Last update in DRKS:
- 2022-01-18
- Registration type:
- Prospective
Acronym/abbreviation of the study
fitcor
URL of the study
No Entry
Brief summary in lay language
This study examines the extent to which various digital interventions can support health care workers in dealing with stress. For this purpose, nurses from hospitals, inpatient geriatric care facilities, and outpatient care services, as well as office staff in hospitals, participate in various digital interventions, either in an app or via a website. Participation in the interventions should lead to health care workers becoming informed about the topic of stress and its effects, as well as their own current stress levels. They will also learn strategies, such as meditation exercises, to better manage stress levels in the long term. The goal is to find out which of the digital interventions achieves the greatest positive effects for the participants. It will also be examined whether the digital offerings still need to be optimized.
Brief summary in scientific language
To achieve the above described objectives, a quantitative, longitudinal data collection is planned. The effectiveness of the digital interventions will be examined by means of quantitative data collection at three measurement time points with a total of 5 different intervention groups and one waiting control group. Participants will be randomly assigned to one of the groups in an experimental design. Measurements for each of the intervention groups will be conducted before the start of the intervention, immediately after the end of the intervention (approximately 6 weeks), and after another six weeks (sustainability). Validated questionnaires will be used to assess team conflict (intragroup conlfict scale), thestage of behavioral change within the Health Action Prosess Approach (HAPA), work-related behavior and experience (AVEM), personality (BFI-10), satisfaction with digital training (CSQ-I), back pain (self-developed), sleep behavior (SQI), and stress perception (PSS10). In addition, physiological data (heart rate, heart rate variability, sleep, exercise) will be collected using a sonor that will be taped to the chest.
Health condition or problem studied
- ICD10:
- Z73 - Problems related to life-management difficulty
- ICD10:
- G47 - Sleep disorders
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Intervention Group: Receives standardized and not specific to individual needs online course focused on stress or sleep. Questionnaire and sensor measurement at three time points: pre-intervention, post-intervention, sustainability (6 weeks).
- Arm 2:
- Intervention group: Receives an online course specifically tailored to individual needs with a focus on stress or sleep. Questionnaire and sensor measurement at three time points: pre-intervention, post-intervention, sustainability (6 weeks).
- Arm 3:
- Intervention group: receives a stress management intervention in an app that includes a biofeedback phase. Questionnaire and sensor measurement at three time points: pre-intervention, post-intervention, sustainability (6 weeks).
- Arm 4:
- Intervention group: Receives a stress management intervention in an app that includes a biofeedback phase. In addition, after completion of the intervention, an evaluation of their own health values in the form of a report. Questionnaire and sensor measurement at three time points: pre-intervention, post-intervention, sustainability (6 weeks).
- Arm 5:
- Intervention group: Receives an online course specifically tailored to individual needs with a focus on stress or sleep. In addition, accompanying telephone coaching. Questionnaire and sensor measurement at three points in time: pre-intervention, post-intervention, sustainability (6 weeks).
- Arm 6:
- Waiting control group: Waiting first and then randomly assigned to receive the intervention from arm 3 or arm 4. Questionnaire and sensor measurement at three time points: pre-wait, post-wait=pre-intervention, post-intervention.
Endpoints
- Primary outcome:
- Physiological stress (HRV age, sympathovagal balance (PNS_SNS_ratio/day)), sleep (duration, recovery, body temperature, thoracal impedance, risk of sleep apnoe), accelerometrics (steps/day, physical activity (min/day), moderate-to-vigorous physical activitiy (min/day), physical activity level (MJ/day), metabolic equivalent of task (METmin/day), physical inactivitiy (min/day)), subjective stress experiences (PSS-10), behavioral change (adapted HAPA questionnaire), Pittsburgh Sleep Quality Index (PSQI). All outcomes are assessed at each measurement times (pre-, postintervention, sustainability)
- Secondary outcome:
- Demographic influences (age, gender), personality (BFI-10), work-related behavior and experience (AVEM), team conflict (intra-group conflict), acceptance (CSQ-I), app use behavior (app), back complaints, stress, stress symptoms (self-developed). All outcomes are assessed at each measurement times (pre-, postintervention, sustainability)
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
-
- Data analyst
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Other Krankenhaus, stationäre Altenpflege, ambulante Altenpflege, Kaufmännisches Personal in Pflegeeinrichtungen Deutschlandweit
Recruitment period and number of participants
- Planned study start date:
- 2021-07-19
- Actual study start date:
- 2021-07-19
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 762
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Work in nursing as a caregiver or in administration, smartphone with internet access, fluent German language skills
Exclusion Criteria
Visual and hearing impairments that do not allow to perform video- or audio-guided exercises on a smartphone or laptop.
Addresses
Primary Sponsor
- Address:
- TU BerlinProf. Dr. Bettina WollesenFasanenstr. 110623 BerlinGermany
- Telephone:
- +49 30 314-79 477
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.bpn.tu-berlin.de/menue/team/bettina_wollesen/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- TU BerlinProf. Dr. Bettina WollesenFasanenstr. 110623 BerlinGermany
- Telephone:
- +49 30 314-79 477
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.bpn.tu-berlin.de/menue/team/bettina_wollesen/
Contact for Public Queries
- Address:
- TU BerlinLuis HeuelFasanenstr. 110623 BerlinGermany
- Telephone:
- 00491785810514
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.bpn.tu-berlin.de/menue/team/luis_heuel/
Principal Investigator
- Address:
- TU BerlinProf. Dr. Bettina WollesenFasanenstr. 110623 BerlinGermany
- Telephone:
- +49 30 314-79 477
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.bpn.tu-berlin.de/menue/team/bettina_wollesen/
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- corvolution GmbHZehntwiesenstr. 35 b76275 EttlingenGermany
- Telephone:
- +49 7243 20710-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://corvolution.com/
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Fitbase Institut für Online Prävention GmbHRuckteschellweg 8a22089 HamburgGermany
- Telephone:
- +49 40 28476233
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://fitbase.de/
Ethics Committee
Address Ethics Committee
- Address:
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-02-08
- Ethics committee number:
- BPN_WOL_4_210202
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-06-04
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:
- The data cannot be shared even in anonymized form due to data protection regulations of the participating organizations.
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:
- No Entry
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