Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety
  • Behavior, Health
  • Psychological Disorder
  • Communication
  • Health Care Seeking Behavior
  • Psychological Distress
  • Health Risk Behaviors
  • Healthy Lifestyle
  • Psychological Stress
  • Parkinson
  • Psychological Adaptation
  • Psychological Impairment
  • Psychological Adjustment
  • Psychological Disability
  • Psychosomatic Disorder
  • Psychological Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The methodology uses a natural variation design within the Dr. Becker Clinical Group and in comparison to group treated at the Paracelsus clinic. 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).Masking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

In Germany, the SARS-CoV-2 pandemic represents a crisis with massive effects on health and rehabilitation care. This crisis is not a short-term event but will also has longer-term effects on health care service/rehabilitation. Necessary adjustments due to hygiene and distance regulations include, fo...

In Germany, the SARS-CoV-2 pandemic represents a crisis with massive effects on health and rehabilitation care. This crisis is not a short-term event but will also has longer-term effects on health care service/rehabilitation. Necessary adjustments due to hygiene and distance regulations include, for example, the reduction of group sizes and alternatives to conventional service provision (= digital services, McNeary et al., 2020). How such offers are perceived and accepted by patients and staff is crucial for the effect on the care. Systematic research into the pandemic from the patient and employee perspective, its consequences for procedures in rehabilitation clinics and for the implementation of the necessary therapies is required in a timely manner in order to better understand and mitigate the effects of the pandemic and to ensure the effectiveness of rehabilitation. This is the aim of this project with a focus on digital services and their subjective usefulness. Furthermore, the integration of such offers can mean that a therapist is not present during the entire therapy, but that rehabilitants first learn the basics of a topic in self-study. This is based on the principle of the "Flipped Classroom". (Rehab) Patients as well as employees of the clinics are involved in the piloting of the survey instruments and the final choice of outcome criteria as well as the derivation of possible applications (guidelines, recommendations for rehabilitants). The following questions will be empirically investigated: How are digital services evaluated regarding feasibility, acceptance and subjective usefulness in light of the current situation? Which characteristics of rehabilitants are related to the acceptance and subjective usefulness of digital offers? For which patients of rehabilitation is there a need for support in the use of digital services to achieve rehabilitation goals? Are there differences in perceived usefulness between services? The methodology uses a natural variation design within the Dr. Becker Clinical Group and the Paracelsus Clinic in order to investigate the issues at the highest possible scientific level and to achieve reliable results. 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). Furthermore, all groups receive patient training before rehabilitation with the content of setting "treatment goals" as well as an invitation to pre- and post-surveys. The survey methods are online surveys (before the treatment=pre; end of treatment=post; by means of UniPark) or qualitative surveys of employees and the patients who did not participate in the pre-measurement. The main target variables are reported behavior and well-being (stress/burden of COVID-19 disease or probability of disease, limitations, quality of life, anxiety or depression; pre-post comparison) as well as subjective need (pre) and benefit (post) of the digital services. The theoretical foundation for the selection of target variables and constructs is the Carry-Over Action Model. The sample includes all rehabilitands who undergo a psychosomatic rehabilitation in the hospitals. The planned sample size of the rehabilitants is N = 1,200; in addition, N = 30 employees will be interviewed about their perspectives by means of qualitative computer-assisted interviews (CATIs). The feasibility is given by the use of an existing care system with cover letters from the patients before the treatment. Possible disturbance variables such as affinity towards technology (which could lead to a lower participation rate among participants with little affinity towards technology) are controlled for and taken into account in the evaluation by conducting qualitative interviews. Gender and diversity are considered as covariates or moderators in the statistical models. All data of the participants will be treated in accordance with the data security regulations (DSGVO), good scientific practice and the ethical requirements. Furthermore, all patients are informed about the project, ethics and data protection in a generally understandable way by a cover letter from their clinic before the treatment. All project staff are obliged to comply with the ethics guidelines and to maintain confidentiality. The pre- and post-data of the patients are combined by means of a personal code, which does not allow any conclusion about the participant. The results of this study will show which digital implementation forms of therapy offers are feasible in terms of benefit and acceptance and can thus contribute to the further development of health care services and medical rehabilitation. This will create the necessary evidence base to include digital offers in the classification of therapeutic services and the therapy standards based on them and thus to establish them in routine care. Furthermore, a guideline for the future integration of these services into the health care services/rehabilitation process will be developed. Due to the standardized combination of analogue and digital therapy parts, therapy goals can be achieved more efficiently on the basis of the validated pedagogical concepts used and with the involvement of fewer human resources. This is not only relevant during the SARS-CoV-2 pandemic, but also with regard to the relevant shortage of qualified personnel.

Tracking Information

NCT #
NCT04453475
Collaborators
  • Dr. Becker Klinikgruppe
  • Dr. Becker Burg-Klinik (Burg)
  • Dr. Becker Klinik Norddeich (NOR)
  • Dr. Becker Klinik Juliana (JUL)
  • Dr. Becker Klinik Möhnesee
  • Paracelsus Klinik Bremen
Investigators
Principal Investigator: Sonia Lippke, Prof. Dr. Jacobs University Bremen