<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453475</url>
  </required_header>
  <id_info>
    <org_study_id>Anhand-COVID19</org_study_id>
    <nct_id>NCT04453475</nct_id>
  </id_info>
  <brief_title>Feasibility and Benefits of Digital Services During the COVID19 Pandemic</brief_title>
  <acronym>AnhandCOV19</acronym>
  <official_title>Therapies to Achieve Treatment Goals While Being Exposed to Hygiene and Distance Rules: Feasibility and Benefits of Digital Services During the COVID19 Pandemic (Anhand-COVID19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jacobs University Bremen gGmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dr. Becker Hospital Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dr. Becker Burg-Klinik (Burg)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dr. Becker Klinik Norddeich (NOR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dr. Becker Klinik Juliana (JUL)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dr. Becker Klinik Möhnesee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jacobs University Bremen gGmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As a result of the pandemic, hygiene and distancing rules must be followed in Health care/&#xD;
      rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive&#xD;
      changes in the therapy processes, including a reduction in group sizes and maintaining&#xD;
      distances within the groups, resulting in a reduction in the range of therapies available to&#xD;
      individuals, since the number of employees remains unchanged and cannot be increased at will&#xD;
      and in the short term due to the lack of qualified staff. In order for the&#xD;
      treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of&#xD;
      therapy programs must be developed in addition to organizational adjustments. Digitalization&#xD;
      can be a significant support in this respect. The majority of patients in psychosomatic&#xD;
      rehabilitation possess smartphones, meaning that the necessary infrastructure for the&#xD;
      utilization of digital offers is available and can be used to the greatest possible extent.&#xD;
      The use of digital measures within the therapeutic services supports the independence of the&#xD;
      patients, as they can use the digital offers independently and flexibly in their own time.&#xD;
&#xD;
      How should Health care/rehabilitation services be designed in light of the SARS-CoV-2&#xD;
      pandemic and which services have the potential to buffer future crises: What general&#xD;
      recommendations can be derived for the design of such services for routine care? What are&#xD;
      support measures to encourage social participation and return to work?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Germany, the SARS-CoV-2 pandemic represents a crisis with massive effects on health and&#xD;
      rehabilitation care. This crisis is not a short-term event but will also has longer-term&#xD;
      effects on health care service/rehabilitation. Necessary adjustments due to hygiene and&#xD;
      distance regulations include, for example, the reduction of group sizes and alternatives to&#xD;
      conventional service provision (= digital services, McNeary et al., 2020). How such offers&#xD;
      are perceived and accepted by patients and staff is crucial for the effect on the care.&#xD;
      Systematic research into the pandemic from the patient and employee perspective, its&#xD;
      consequences for procedures in rehabilitation clinics and for the implementation of the&#xD;
      necessary therapies is required in a timely manner in order to better understand and mitigate&#xD;
      the effects of the pandemic and to ensure the effectiveness of rehabilitation. This is the&#xD;
      aim of this project with a focus on digital services and their subjective usefulness.&#xD;
&#xD;
      Furthermore, the integration of such offers can mean that a therapist is not present during&#xD;
      the entire therapy, but that rehabilitants first learn the basics of a topic in self-study.&#xD;
      This is based on the principle of the &quot;Flipped Classroom&quot;. (Rehab) Patients as well as&#xD;
      employees of the clinics are involved in the piloting of the survey instruments and the final&#xD;
      choice of outcome criteria as well as the derivation of possible applications (guidelines,&#xD;
      recommendations for rehabilitants).&#xD;
&#xD;
      In addition, the pandemic is negatively associated with equal participation of vulnerable&#xD;
      groups (e.g. persons with physical or psychological handicaps). In the case of medical&#xD;
      rehabilitation patients, particular occupational problems make equal participation and social&#xD;
      cohesion more difficult: problems such as long-term limited productivity or the threat of&#xD;
      exclusion from the labor market (pension for reduced earning capacity), negative employment&#xD;
      forecasts and experiences of previously limited social participation are in turn further&#xD;
      exacerbated by demographic change and the consequences of the COVID 19 pandemic. These&#xD;
      restrictions are also reflected in the increased experience of loneliness. To date, however,&#xD;
      there is a lack of a systematic understanding of these circular, dynamic processes and&#xD;
      low-threshold, effective approaches to action, effective approaches to action.&#xD;
&#xD;
      The following questions will be empirically investigated:&#xD;
&#xD;
        1. How are digital services evaluated regarding feasibility, acceptance and subjective&#xD;
           usefulness in light of the current situation?&#xD;
&#xD;
        2. Which characteristics of rehabilitants are related to the acceptance and subjective&#xD;
           usefulness of digital offers?&#xD;
&#xD;
        3. For which patients of rehabilitation is there a need for support in the use of digital&#xD;
           services to achieve rehabilitation goals?&#xD;
&#xD;
        4. Are there differences in perceived usefulness between services?&#xD;
&#xD;
        5. How do people in the welfare state and labor market with disabilities and impairments&#xD;
           (rehabilitants) perceive the consequences of the Covid 19 pandemic and the&#xD;
           transformation processes?&#xD;
&#xD;
        6. How effective are support measures with regard to communication for rehabilitants in&#xD;
           supporting equal participation?&#xD;
&#xD;
        7. How should support for equal participation be designed in the long term: What What are&#xD;
           the consequences for labor market and social policy?&#xD;
&#xD;
      The methodology uses a natural variation design within the Dr. Becker Clinical Group in order&#xD;
      to investigate the issues at the highest possible scientific level and to achieve reliable&#xD;
      results. The interventions consist of an online depression session as a &quot;flipped classroom&quot;&#xD;
      and/or an online lecture with socio-medical content, and/ or a tobacco cessation lecture,&#xD;
      which are combined in such a way that the differential effects can be evaluated. For this&#xD;
      purpose, a control group is included that does not participate in these interventions (but&#xD;
      receives the standard rehabilitation treatment programm). Furthermore, all groups voluntarily&#xD;
      receive patient training before rehabilitation with the content of setting &quot;treatment goals&quot;&#xD;
      as well as an invitation to pre- and post-surveys.&#xD;
&#xD;
      The survey methods are online surveys (before the treatment=pre (T1); end of treatment=post&#xD;
      (T2); end of treatment=post 12 weeks (T3)) by means of UniPark.&#xD;
&#xD;
      The main target variables are reported behavior and well-being (stress/burden of COVID-19&#xD;
      disease or probability of disease, limitations, quality of life, anxiety or depression;&#xD;
      pre-post comparison) as well as subjective need (pre) and benefit (post) of the digital&#xD;
      services. Further primary target variables are concentrated on social participation,&#xD;
      workability and return to work. The theoretical foundation for the selection of target&#xD;
      variables and constructs is the Carry-Over Action Model. The sample includes all&#xD;
      rehabilitands who undergo a psychosomatic rehabilitation in the hospitals. The planned sample&#xD;
      size of the rehabilitants is N = 2,000.&#xD;
&#xD;
      The feasibility is given by the use of an existing care system with cover letters from the&#xD;
      patients before the treatment. Possible disturbance variables such as affinity towards&#xD;
      technology (which could lead to a lower participation rate among participants with little&#xD;
      affinity towards technology) are controlled for and taken into account in the evaluation.&#xD;
      Gender and diversity are considered as covariates or moderators in the statistical models.&#xD;
&#xD;
      All data of the participants will be treated in accordance with the data security regulations&#xD;
      (DSGVO), good scientific practice and the ethical requirements. Furthermore, all patients are&#xD;
      informed about the project, ethics and data protection in a generally understandable way by a&#xD;
      cover letter from their clinic before the treatment. All project staff are obliged to comply&#xD;
      with the ethics guidelines and to maintain confidentiality. The pre- and post-data of the&#xD;
      patients are combined by means of a personal code, which does not allow any conclusion about&#xD;
      the participant.&#xD;
&#xD;
      The results of this study will show which digital implementation forms of therapy offers are&#xD;
      feasible in terms of benefit and acceptance and can thus contribute to the further&#xD;
      development of health care services and medical rehabilitation. This will create the&#xD;
      necessary evidence base to include digital offers in the classification of therapeutic&#xD;
      services and the therapy standards based on them and thus to establish them in routine care.&#xD;
      Furthermore, a guideline for the future integration of these services into the health care&#xD;
      services/rehabilitation process will be developed. Due to the standardized combination of&#xD;
      analogue and digital therapy parts, therapy goals can be achieved more efficiently on the&#xD;
      basis of the validated pedagogical concepts used and with the involvement of fewer human&#xD;
      resources. This is not only relevant during the SARS-CoV-2 pandemic, but also with regard to&#xD;
      the relevant shortage of qualified personnel. Furthermore, the research basis for digital&#xD;
      measures to support social support for social participation will be created. With these&#xD;
      findings, similar measures on other groups, for example, persons with disabilities or&#xD;
      limitations, can be researched.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The methodology uses a natural variation design within the Dr. Becker Clinical Group. The interventions consist of an online depression session as a &quot;flipped classroom&quot; 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).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences)</measure>
    <time_frame>T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)</time_frame>
    <description>Quantitative online questionnaire Survey using UniPark</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usability and effectiveness of digital interventions</measure>
    <time_frame>T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)</time_frame>
    <description>Quantitative online questionnaire Survey using UniPark</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stressors and barriers due to Covid-19</measure>
    <time_frame>T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)</time_frame>
    <description>Quantitative online questionnaire Survey using UniPark</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2000</enrollment>
  <condition>Psychosomatic Disorder</condition>
  <condition>Psychological Distress</condition>
  <condition>Psychological Stress</condition>
  <condition>Psychological Disease</condition>
  <condition>Psychological Disorder</condition>
  <condition>Psychological Impairment</condition>
  <condition>Psychological Disability</condition>
  <condition>Psychological Adjustment</condition>
  <condition>Psychological Adaptation</condition>
  <condition>Communication</condition>
  <condition>Health Care Seeking Behavior</condition>
  <condition>Anxiety</condition>
  <condition>Behavior, Health</condition>
  <condition>Health Risk Behaviors</condition>
  <condition>Healthy Lifestyle</condition>
  <arm_group>
    <arm_group_label>Partial digital group: depression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burg&#xD;
Online depression session as a &quot;flipped classroom&quot; and voluntary low-threshold communication trainings as well as training on rehabilitation goals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partial digital group: social work (social medicine)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NOR&#xD;
Online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partial digital group: depression + social work</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JUL&#xD;
Online depression session as a &quot;flipped classroom&quot; and an online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: only digital training before rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MOE&#xD;
Online tobacco cessation a &quot;flipped classroom&quot; and voluntary low-threshold communication trainings as well as training on rehabilitation goals</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training session adressing information and health literacy</intervention_name>
    <description>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</description>
    <arm_group_label>Control group: only digital training before rehabilitation</arm_group_label>
    <arm_group_label>Partial digital group: depression</arm_group_label>
    <arm_group_label>Partial digital group: depression + social work</arm_group_label>
    <arm_group_label>Partial digital group: social work (social medicine)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients before the start of the treatment&#xD;
&#xD;
          -  Selected by the clinic&#xD;
&#xD;
          -  Invited to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to read and write&#xD;
&#xD;
          -  Severe dementia&#xD;
&#xD;
          -  unwillingness to participate in the study and to sign consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonia Lippke, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jacobs University Bremen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jacobs University Bremen gGmbH</name>
      <address>
        <city>Bremen</city>
        <zip>28759</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Baumeister, H., Reichler, L., Munzinger, M., &amp; Lin, J. (2014). The impact of guidance on Internet-based mental health interventions - A systematic review. Internet Interventions, 1(4), 205-215. &lt;br /&gt; Direito, A., Carraça, E., Rawstorn, J., Whittaker, R., &amp; 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 &lt;br /&gt; 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 &lt;br /&gt; Fleig, L., Lippke, S., Pomp, S., &amp; 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. &lt;br /&gt; Fleig, L., Pomp, S., Schwarzer, R., &amp; Lippke, S. (2013). Promoting exercise maintenance: How interventions with booster sessions improve long-term rehabilitation outcomes. Rehabilitation Psychology, 58, 323-333. &lt;br /&gt; Granja, C., Janssen, W., &amp; 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 &lt;br /&gt; Hong, Z., Li, N., Li, D., Li, J., Li, B., Xiong, W., Lu, L., Li, W., &amp; Zhou, D. (2020). Telemedicine during the COVID-19 pandemic: experiences from Western China. Journal of Medical Internet Research, 22, e19577. &lt;br /&gt; Lippke, S., Preißner, C., &amp; 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. &lt;br /&gt; Lustria, M. L. A., Noar, S. M., Cortese, J., Van Stee, S. K., Glueckauf, R. L., &amp; 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 &lt;br /&gt; 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 &lt;br /&gt; Milne-Ives, M., Lam, C., De Cock, C., Van Velthoven, M. H., &amp; 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 &lt;br /&gt; Padala, P. R., Jendro, A. M., &amp; Padala, K. P. (2020). Conducting clinical research during the COVID-19 pandemic: investigator and participant perspectives. JMIR Public Health Surveillance, 6, e18887. &lt;br /&gt; 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. &lt;br /&gt; 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 &lt;br /&gt; Sheehy, L. M. (2020). Considerations for postacute rehabilitation for survivors of COVID-19. JMIR Public Health Surveillance, 6, e19462. &lt;br /&gt; Storm, V., Dörenkämper, J., Reinwand, D., Wienert, J., De Vries, H., &amp; 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. &lt;br /&gt; Vugts, M. A. P., Joosen, M. C. W., van der Geer, J. E., Zedlitz, A. M. E. E., &amp; 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 &lt;br /&gt; Weisel, K. K., Fuhrmann, L. M., Berking, M., Baumeister, H., Cuijpers, P., &amp; Ebert, D. D. (2019). Standalone smartphone apps for mental health - a systematic review and meta-analysis. npj Digital Medicine, 2, 1-10.</citation>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>34270444</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>34501524</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>33831971</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>34544173</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>35266309</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>health behavior change</keyword>
  <keyword>stress</keyword>
  <keyword>eHealth</keyword>
  <keyword>digital intervention</keyword>
  <keyword>medical rehabilitation</keyword>
  <keyword>clinic stay</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Psychophysiologic Disorders</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data (IPD) will not be published. Other researchers are welcome to get in contact with the PI to get access to anonymous data.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453475
org study id: Anhand-COVID19
nct id: NCT04453475
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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?
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).

      In addition, the pandemic is negatively associated with equal participation of vulnerable
      groups (e.g. persons with physical or psychological handicaps). In the case of medical
      rehabilitation patients, particular occupational problems make equal participation and social
      cohesion more difficult: problems such as long-term limited productivity or the threat of
      exclusion from the labor market (pension for reduced earning capacity), negative employment
      forecasts and experiences of previously limited social participation are in turn further
      exacerbated by demographic change and the consequences of the COVID 19 pandemic. These
      restrictions are also reflected in the increased experience of loneliness. To date, however,
      there is a lack of a systematic understanding of these circular, dynamic processes and
      low-threshold, effective approaches to action, effective approaches to action.

      The following questions will be empirically investigated:

        1. How are digital services evaluated regarding feasibility, acceptance and subjective
           usefulness in light of the current situation?

        2. Which characteristics of rehabilitants are related to the acceptance and subjective
           usefulness of digital offers?

        3. For which patients of rehabilitation is there a need for support in the use of digital
           services to achieve rehabilitation goals?

        4. Are there differences in perceived usefulness between services?

        5. How do people in the welfare state and labor market with disabilities and impairments
           (rehabilitants) perceive the consequences of the Covid 19 pandemic and the
           transformation processes?

        6. How effective are support measures with regard to communication for rehabilitants in
           supporting equal participation?

        7. How should support for equal participation be designed in the long term: What What are
           the consequences for labor market and social policy?

      The methodology uses a natural variation design within the Dr. Becker Clinical Group 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, and/ or a tobacco cessation lecture,
      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 participate in these interventions (but
      receives the standard rehabilitation treatment programm). Furthermore, all groups voluntarily
      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 (T1); end of treatment=post
      (T2); end of treatment=post 12 weeks (T3)) by means of UniPark.

      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. Further primary target variables are concentrated on social participation,
      workability and return to work. 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 = 2,000.

      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.
      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. Furthermore, the research basis for digital
      measures to support social support for social participation will be created. With these
      findings, similar measures on other groups, for example, persons with disabilities or
      limitations, can be researched.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 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).
primary purpose: Health Services Research
masking: None (Open Label)
measure: Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences)
time frame: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
description: Quantitative online questionnaire Survey using UniPark
measure: Usability and effectiveness of digital interventions
time frame: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
description: Quantitative online questionnaire Survey using UniPark
measure: Stressors and barriers due to Covid-19
time frame: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
description: Quantitative online questionnaire Survey using UniPark
arm group label: Partial digital group: depression
arm group type: Experimental
description: Burg
Online depression session as a "flipped classroom" and voluntary low-threshold communication trainings as well as training on rehabilitation goals
arm group label: Partial digital group: social work (social medicine)
arm group type: Experimental
description: NOR
Online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals
arm group label: Partial digital group: depression + social work
arm group type: Experimental
description: 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
arm group label: Control group: only digital training before rehabilitation
arm group type: Active Comparator
description: MOE
Online tobacco cessation a "flipped classroom" and voluntary low-threshold communication trainings as well as training on rehabilitation goals
intervention type: Behavioral
intervention name: Training session adressing information and health literacy
description: 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
arm group label: Control group: only digital training before rehabilitation
arm group label: Partial digital group: depression
arm group label: Partial digital group: depression + social work
arm group label: Partial digital group: social work (social medicine)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sonia Lippke, Prof. Dr.
role: Principal Investigator
affiliation: Jacobs University Bremen
facility: 
country: Germany
citation: 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.
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Psychophysiologic Disorders
mesh term: Stress, Psychological
mesh term: Mental Disorders
mesh term: Somatoform Disorders
sharing ipd: No
ipd description: Individual participant data (IPD) will not be published. Other researchers are welcome to get in contact with the PI to get access to anonymous data.