ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan for Patients Infected With COVID-19
Condition: Long-COVID; Post-COVID; Psychosomatic Disorder; Psychological Distress; Psychological Disease; Psychological Disorder; Psychological Impairment; Psychological Adjustment; Physiological Disease; Physiological Disorder; Physiological Impairment; Physiological Adjustment; Healthy Lifestyle
MeSH terms: Post-Acute COVID-19 Syndrome; Psychophysiologic Disorders; Mental Disorders; Somatoform Disorders
Study type: Interventional

Summary: 
      Post-/long-COVID occurs in patients with severe, moderate, and even mild courses. The
      symptomatology is multi-layered and complex. Patients with mild and moderate courses and
      especially younger patients are not optimally integrated into one of the existing care
      structures of COVID outpatient clinics and regular primary care. The diagnosis of
      post-/long-COVID and a consequent targeted treatment are currently partly not ensured. The
      variability of symptoms and the resulting complexity of diagnosis and treatment also pose a
      challenge in rural areas.

      The aim of the project is an evaluation of a program for low-threshold needs identification
      and treatment planning for a hybrid (personal supporting counselors and digital trainings)
      post-/long-COVID care.

      The contents of the present project include an innovative basis outside the existing standard
      care for the identification of affected persons. This will be done by means of a
      low-threshold online screening, which can also be carried out by the affected persons
      themselves. Furthermore, an intensive interdisciplinary assessment linked to medical
      rehabilitation resulting in a comprehensive, interdisciplinary, and cross-sectoral treatment
      plan is a core component of the current project. Finally, the implementation of digital
      trainings which are accompanied by a personal supporting counselor and augmented by
      continuously available trainings in the form of digital modules aim to provide general
      recommendation for the future support of post/long-COVID care.

      The current research project aims to evaluate the feasibility and the practicability of a
      comprehensive, interdisciplinary, and cross-sectoral treatment program consisting of a
      low-threshold online screening and holistic assessment for PACS. Furthermore, it aims to
      evaluate digital interventions and the use of so-called personal guides that may help to
      facilitate the recovery of PACS.
    

Detailed description: 
      The goal is the long-term and sustainable holistic treatment and support of patients with
      post-/long-COVID to prevent long-term illness and chronification. Following the earliest
      possible, low-threshold identification of post-/long-COVID sufferers, an intensive
      multidisciplinary assessment is conducted, resulting in holistic treatment planning based on
      the results of the assessment. This consists of recommendations for a coordinated,
      interdisciplinary therapy plan. At the same time, digital therapy offers are recommended and
      made available to patients. Patients are accompanied by a supporting counselor (personal
      pilot) who guides them through the entire care process. This closes the gap between acute
      care of COVID-19 and outpatient therapy or rehabilitation of post-/long-COVID.

      To identify patients with post-/long-COVID symptoms, a low-threshold scientifically based
      online-screening that confirms the presence of post-/long-COVID syndrome and an three day
      inpatient assessment that determines the need for further treatment will be developed,
      validated and prepared for standard care. Long-term goals are the dissemination of the
      validated instruments to diagnose post-long-COVID and treatment approaches
      (interdisciplinary, individualized treatment plan) through communication to key stakeholders
      such as medical associations, health insurance companies, service providers in the outpatient
      and inpatient sector, as well as professional societies and care institutions. This is
      intended to improve patient care and make care delivery of treatments for post-/long-COVID
      patients more efficient beyond the project duration.

      Standard care currently diagnoses post-/long-COVID and provides recommendations for treatment
      through primary care practices and specialized post-COVID outpatient clinics. Both access
      routes inadequately reach those affected especially in rural areas. Long-/post-COVID
      outpatient clinics are primarily located in metropolitan areas and are therefore mainly
      available to the population in large cities. In particular, young affected individuals who
      have had little to no prior outpatient care due to a very mild course do not have primary
      care and often do not have the knowledge of the specific post-/long-COVID symptomatology and
      potentially seek insufficient and delayed medical support. This may result in aggravation and
      possibly chronification of symptoms and consequent long-term disability/ incapacity with
      limited participation. This in turn can have a negative impact on the continuation or
      resumption of work and lead to economic burdens for the whole society.

      The contents of the present project include, as an innovative basis outside the existing
      standard care, the low-threshold identification of affected persons, an intensive
      interdisciplinary assessment resulting in a comprehensive, interdisciplinary and
      cross-sectoral treatment plan, the implementation of which is controlled and accompanied by a
      personal supporting counselor and augmented by continuously available training in the form of
      digital offers.

      The following research questions and hypotheses will be investigated with this project and
      subsequently communicated to the various stakeholders and the general public:

        1. What screening tool can reliably identify patients suffering from post/long-COVID
           syndrome? Hypothesis: With a simplified screening, the presence of post/long-COVID can
           be identified in a low-threshold manner.

        2. Which assessments can be used to reliably determine the need for therapy or
           rehabilitation and the leading rehabilitation indication? Hypothesis: With a
           comprehensive assessment, the need for rehabilitation and the leading rehabilitation
           indication can be determined validly and reliably.

        3. What must digital therapy offerings look like to benefit patients with post/long-COVID
           syndrome? Hypothesis: Digital therapy offerings with an individualizable focus achieve
           the best success in the treatment of post/long-COVID.

        4. What information must the supporting counselor have to ensure management of
           interdisciplinary treatment? Hypothesis: As a point of contact for all stakeholders, a
           supporting counselor will have interdisciplinary and intersectoral treatment planning
           available to ensure sustained management of interdisciplinary treatment.

        5. How should an interdisciplinary treatment pathway look like in the long term?
           Hypothesis: An interdisciplinary treatment pathway must guide the patient, with the
           support of the supporting counselor, in such a way that he or she experiences the
           appropriate diagnosis and treatment for him or herself and actively participates in
           recovery so that he or she recovers quickly and sustainably from his or her
           post/long-COVID disease, increases his or her functional capacity, reduces incapacity to
           work, and regains participation.

      The project aims to optimize care for post-/long-COVID patients and empower them to
      participate socially. Affected individuals are supported on their way to the appropriate
      therapeutic and rehabilitative care by expert staff, the supporting counselors (personal
      pilots), and receive interdisciplinary multi-professional treatment focused on individual
      complaints. Affected individuals are accompanied and supported through digital interventions.
      The low-threshold access via an online-screening leads to the elimination of information loss
      and inhibitions. Various digital services, such as DiGAs, video consultations, as well as
      aftercare services are increasingly used. This is of particular benefit to patients who have
      tight schedules and/or live in rural regions with a low density of doctors/therapists.
    

Intervention name(s): Psychological and Physiological Assessments
Intervention type(s): Diagnostic Test
Intervention description(s): About N = 60 patients admitted to the study receive a 3-day assessment (a further examination) at the Kiliani-Klinik Bad Windsheim which considers physical and psychological parameters relevant for the diagnosis of a Post-/ Long-COVID Syndrom.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This study has three study arms. Specifically, patients will be randomly assigned to an intervention group or an active control group. Furthermore, a comparison group will be recruited. Whereas the CompG will not receive any treatment, the IG and the ACG will have contacts with a personal pilot who will help the patients to navigate through the study as well as through treatment options and help them seek help for further needs. Aditionally, the intervention group will receive a so called 3-day assessment in a clinic and in which patients will be assessed by a multiprofessional team of health care professionals regarding their post-/long-COVID symptoms.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Post-COVID; Long-COVID; treatment plan; eHealth; digital intervention; medical rehabilitation; psychosomatic rehabilitation