Feasibility and Benefits of Digital Services During the COVID19 Pandemic

NCT04453475 | Completed

• 1 other identifier: Anhand-COVID19
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care? What are support measures to encourage social participation and return to work?

Conditions

Psychosomatic Disorder; Psychological Distress; Psychological Stress; Psychological Disease; Psychological Disorder; Psychological Impairment; Psychological Disability; Psychological Adjustment; Psychological Adaptation; Communication; Health Care Seeking Behavior; Anxiety; Behavior, Health; Health Risk Behaviors; Healthy Lifestyle

Keywords

health behavior change; stress; eHealth; digital intervention; medical rehabilitation; clinic stay

Outcome Measures

Primary Outcomes (3)

• Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences)

  Quantitative online questionnaire Survey using UniPark

  T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

• Usability and effectiveness of digital interventions

  Quantitative online questionnaire Survey using UniPark

  T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

• Stressors and barriers due to Covid-19

  Quantitative online questionnaire Survey using UniPark

  T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

Study Arms (4)

Partial digital group: depression

EXPERIMENTAL

Burg Online depression session as a "flipped classroom" and voluntary low-threshold communication trainings as well as training on rehabilitation goals

Behavioral: Training session adressing information and health literacy

Partial digital group: social work (social medicine)

EXPERIMENTAL

NOR Online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals

Behavioral: Training session adressing information and health literacy

Partial digital group: depression + social work

EXPERIMENTAL

JUL Online depression session as a "flipped classroom" and an online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals

Behavioral: Training session adressing information and health literacy

Control group: only digital training before rehabilitation

ACTIVE COMPARATOR

MOE Online tobacco cessation a "flipped classroom" and voluntary low-threshold communication trainings as well as training on rehabilitation goals

Behavioral: Training session adressing information and health literacy

Interventions

Training session adressing information and health literacy BEHAVIORAL

The training sessions are provided online and as alternative to face-to-face treatments which cannot be provided as before due to the safety regulations relating to Covid-19

Control group: only digital training before rehabilitation; Partial digital group: depression; Partial digital group: depression + social work; Partial digital group: social work (social medicine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients before the start of the treatment
• Selected by the clinic
• Invited to participate in the study

You may not qualify if:

• Inability to read and write
• Severe dementia
• unwillingness to participate in the study and to sign consent form

Sponsors & Collaborators

• Jacobs University Bremen gGmbH: lead
• Dr. Becker Hospital Group: collaborator
• Dr. Becker Burg-Klinik (Burg): collaborator
• Dr. Becker Klinik Norddeich (NOR): collaborator
• Dr. Becker Klinik Juliana (JUL): collaborator
• Dr. Becker Klinik Möhnesee: collaborator

Study Sites (1)

Jacobs University Bremen gGmbH

Bremen, 28759, Germany

Location

Related Publications (6)

• Baumeister, H., Reichler, L., Munzinger, M., & Lin, J. (2014). The impact of guidance on Internet-based mental health interventions - A systematic review. Internet Interventions, 1(4), 205-215. <br /> Direito, A., Carraça, E., Rawstorn, J., Whittaker, R., & Maddison, R. (2017). mHealth technologies to influence physical activity and sedentary behaviors: behavior change zechniques, systematic review and meta-analysis of randomized controlled trials. Annals of Behavioral Medicine, 51, 226-239. doi: 10.1007/s12160-016-9846-0 <br /> Elbert, N. J., Van Os-Medendorp, H., van Renselaar, W., Ekeland, A. G., Hakkaart-van Roijen, L., Raat, H., … Gma, S. (2014). Effectiveness and cost-effectiveness of eHealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. Journal of Medical Internet Research, 16, e110. doi: 10.2196/jmir.2790 <br /> Fleig, L., Lippke, S., Pomp, S., & Schwarzer, R. (2011). Intervention effects of exercise self-regulation on physical exercise and eating fruits and vegetables: a longitudinal study in orthopedic and cardiac rehabilitation. Preventive Medicine, 53, 182-187. <br /> Fleig, L., Pomp, S., Schwarzer, R., & Lippke, S. (2013). Promoting exercise maintenance: How interventions with booster sessions improve long-term rehabilitation outcomes. Rehabilitation Psychology, 58, 323-333. <br /> Granja, C., Janssen, W., & Johansen, M. A. (2018). Factors determining the success and failure of eHealth interventions: systematic review of the literature. Journal of Medical Internet Research, 20, e10235. doi: 10.2196/10235 <br /> Hong, Z., Li, N., Li, D., Li, J., Li, B., Xiong, W., Lu, L., Li, W., & Zhou, D. (2020). Telemedicine during the COVID-19 pandemic: experiences from Western China. Journal of Medical Internet Research, 22, e19577. <br /> Lippke, S., Preißner, C., & Whittal, A. (2018). Facilitating health literacy and behavior change by computer-tailored interventions. In: A. K. Mayer (Ed.). Health Literacy Across the Life (pp. 39-58). Lengerich: Pabst Science Publishers. <br /> Lustria, M. L. A., Noar, S. M., Cortese, J., Van Stee, S. K., Glueckauf, R. L., & Lee, J. (2013). A meta-analysis of web-delivered tailored health behavior change interventions. Journal of Health Communication: International Perspectives, 18, 1039-1069. doi: 10.1080/10810730.2013.768727 <br /> McNeary, L., Maltser, S., Verduzco-Gutierrez, M. (2020). Navigating coronavirus disease 2019 (Covid-19) in physiatry: a CAN report for inpatient rehabilitation facilities. PM R, 12, 512-515. doi:10.1002/pmrj.12369 <br /> Milne-Ives, M., Lam, C., De Cock, C., Van Velthoven, M. H., & Meinert, E. (2020). Mobile apps for health behaviour change in physical activity, diet, drug and alcohol use, and mental health: a systematic review. JMIR Mhealth Uhealth, 8, e17046. doi: 10.2196/17046 <br /> Padala, P. R., Jendro, A. M., & Padala, K. P. (2020). Conducting clinical research during the COVID-19 pandemic: investigator and participant perspectives. JMIR Public Health Surveillance, 6, e18887. <br /> Pérez Sust, P., Solans, O., Fajardo, J.C., Medina Peralta, M., Rodenas, P., Gabaldà, J., Garcia Eroles, L., …, Piera-Jimenez, J. (2020). Turning the crisis into an opportunity: Digital health strategies deployed during the COVID-19 outbreak. JMIR Public Health Surveillance, 6, e19106. <br /> Schuler, M., Murauer, K., Stangl, S., Grau, A., Gabriel, K., Podger, L., . . . Faller, H. (2019). Pre-post changes in main outcomes of medical rehabilitation in Germany: Protocol of a systematic review and meta-analysis of individual participant and aggregated data. BMJ Open, 9. doi:10.1136/bmjopen-2018-023826 <br /> Sheehy, L. M. (2020). Considerations for postacute rehabilitation for survivors of COVID-19. JMIR Public Health Surveillance, 6, e19462. <br /> Storm, V., Dörenkämper, J., Reinwand, D., Wienert, J., De Vries, H., & Lippke, S. (2016). Effectiveness of a web-based computer-tailored multiple-lifestyle intervention for people interested in reducing their cardiovascular risk: A randomized controlled trial. Journal of Medical Internet Research, 18, e78. <br /> Vugts, M. A. P., Joosen, M. C. W., van der Geer, J. E., Zedlitz, A. M. E. E., & Vrijhoef, H. J. M. (2018). The effectiveness of various computer-based interventions for patients with chronic pain or functional somatic syndromes: A systematic review and meta-analysis. PLoS ONE, 13, e0196467. https://doi.org/10.1371/journal.pone.0196467 <br /> Weisel, K. K., Fuhrmann, L. M., Berking, M., Baumeister, H., Cuijpers, P., & Ebert, D. D. (2019). Standalone smartphone apps for mental health - a systematic review and meta-analysis. npj Digital Medicine, 2, 1-10.

  BACKGROUND

• Keller FM, Dahmen A, Derksen C, Kotting L, Lippke S. Psychosomatic Rehabilitation Patients and the General Population During COVID-19: Online Cross-sectional and Longitudinal Study of Digital Trainings and Rehabilitation Effects. JMIR Ment Health. 2021 Aug 26;8(8):e30610. doi: 10.2196/30610.

  PMID: 34270444 RESULT

• Keller FM, Dahmen A, Derksen C, Kotting L, Lippke S. Implementing Digital Trainings within Medical Rehabilitations: Improvement of Mental Health and Synergetic Outcomes with Healthcare Service. Int J Environ Res Public Health. 2021 Aug 25;18(17):8936. doi: 10.3390/ijerph18178936.

  PMID: 34501524 RESULT

• Dahmen A, Keller F, Kotting L, Derksen C, Lippke S. [Fear of Coronavirus, Intention to Follow the AHA Rules and Risk Perception Regarding Visits to the Doctor: Cross-sectional Study with Patients suffering from Pre-existing Mental Illness]. Gesundheitswesen. 2021 Apr;83(4):274-281. doi: 10.1055/a-1397-7214. Epub 2021 Apr 8. German.

  PMID: 33831971 RESULT

• Dahmen A, Keller FM, Derksen C, Kotting L, Lippke S. [Which Digital Services do Psychosomatic Rehabilitation Patients Use During the Corona Pandemic and do Interrelations with Anxiety and Depressive Symptoms Exist?]. Psychother Psychosom Med Psychol. 2021 Dec;71(12):508-514. doi: 10.1055/a-1503-5548. Epub 2021 Sep 20. German.

  PMID: 34544173 RESULT

• Keller FM, Derksen C, Kotting L, Dahmen A, Lippke S. Distress, loneliness, and mental health during the COVID-19 pandemic: Test of the extension of the Evolutionary Theory of Loneliness. Appl Psychol Health Well Being. 2023 Feb;15(1):24-48. doi: 10.1111/aphw.12352. Epub 2022 Mar 9.

  PMID: 35266309 RESULT

MeSH Terms

Conditions

Psychophysiologic Disorders; Stress, Psychological; Mental Disorders; Communication; Patient Acceptance of Health Care; Anxiety Disorders; Health Behavior; Health Risk Behaviors

Interventions

Health Literacy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Treatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Consumer Health Information; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sonia Lippke, Prof. Dr.

  Jacobs University Bremen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The methodology uses a natural variation design within the Dr. Becker Clinical Group. The interventions consist of an online depression session as a "flipped classroom" and/or an online lecture with socio-medical content, which are combined in such a way that the differential effects can be evaluated. For this purpose, a control group is included that does not receive these two interventions (but receives a similar rehabilitation treatment to the intervention groups).

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)