Clinical trial NCT05238415: ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan for Patients Infected With COVID-19
Official title: ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Post-COVID
Long-COVID
treatment plan
eHealth
digital intervention
medical rehabilitation
psychosomatic rehabilitation
Lead sponsor: Jacobs University Bremen gGmbH
Sponsor class: OTHER
Collaborators: name: Dr. Becker Hospital Group
name: Dr. Becker Kiliani Clinic
name: Dr. Becker Clinic Möhnesee
name: Johannesbad Reha Clinics Bad Füssing
name: Reha-Centre Bad Kötzting
First posted: 2022-02-14
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All people who are resident in Bavaria can participate in the intervention and control group. In the comparison group all people who live and work in Germany can take part
* working age
* ability to participate in surveys (e.g., sufficient German language skills)
* willingness to participate in outpatient or (partially) inpatient therapy
* ability to undergo rehabilitation if necessary, and a telephone and Internet connection
* suspicion of post-/long-COVID

Exclusion Criteria:

* Contraindications regarding physical exercise,
* not being of age,
* illiteracy
* massively limited cognitive abilities (linguistic components of the digital offerings must be able to be used and questionnaires completed or interviews participated in)

Primary outcomes:
measure: Change from baseline in the Post-/ Long-COVID symptoms at 3 months
timeFrame: Baseline to 3 months
measure: Subjective prognosis of return to work
timeFrame: 2 weeks, 8 weeks
Secondary outcomes:
measure: Activity and social participation
timeFrame: 2 weeks, 8 weeks
measure: Health behaviors of daily living
timeFrame: 2 weeks, 8 weeks
measure: Mental health
timeFrame: 2 weeks, 8 weeks
measure: Life satisfaction
timeFrame: 2 weeks, 8 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Dr. Becker Klinikgruppe
Study officials:
affiliation: Jacobs University Bremen
name: Sonia Lippke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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