ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan

Sponsor

Prof. Dr. Sonia Lippke (Other)

Overall Status

Recruiting

CT.gov ID

NCT05238415

Collaborator

Dr. Becker Hospital Group (Other), Dr. Becker Kiliani-Klinik (Other), Dr. Becker Klinik Möhnesee (Other), Johannesbad Reha-Kliniken Bad Füssing (Other), Reha-Zentrum Bad Kötzting (Other)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 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 contents of the present project include as an innovative basis outside the existing standard care the identification of affected persons. This will be done by means of a low-threshold screening, which can also be carried out by the affected persons self-managed. Furthermore, an intensive interdisciplinary assessment linked to medical rehabilitation resulting in a comprehensive, interdisciplinary and cross-sectoral treatment plan is a core component. Finally, the implementation of which is controlled and accompanied by a personal supporting counselor and augmented by continuously available trainings in the form of digital offers aims at general recommendation for future support of post/long-COVID care.

Condition or Disease	Intervention/Treatment	Phase
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	Diagnostic Test: Psychological and Physiological Assessments	N/A

Detailed Description

The goal is the long-term and sustainable holistic treatment and support of patients with a diagnosed post-/long-COVID syndrome 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 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 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 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-19 syndrome and provides recommendations for treatment through primary care practices and specialized post-COVID outpatient clinics. Both access routes inadequately reach young people and those affected in rural areas. 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:

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.
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.
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.
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.
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. Affected individuals are supported on their way to the appropriate therapeutic and rehabilitative care by expert staff, the supporting counselor s, and receive interdisciplinary multi-professional treatment focused on individual complaints. Affected individuals are accompanied and supported through digital therapies. The low-threshold access 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

In this project, a pre-experimental design will be implemented, as randomization to an untreated control group is not ethically justifiable. Instead, a two-group pretest-posttest procedure is chosen, in which a group comparable to the intervention group is recruited and contrasted with the intervention group. The control group will be recruited in the same methodological manner as the intervention group. Subsequently, the subjects are assigned to the groups by randomization. Methodologically, a so-called propensity score matching is used. Both groups are repeatedly interviewed before and after the intervention with the same instruments. In addition, the intervention group will be medically examined by the post-COVID outpatient clinic or the general practitioner as part of the assessment and their routine treatment.In this project, a pre-experimental design will be implemented, as randomization to an untreated control group is not ethically justifiable. Instead, a two-group pretest-posttest procedure is chosen, in which a group comparable to the intervention group is recruited and contrasted with the intervention group. The control group will be recruited in the same methodological manner as the intervention group. Subsequently, the subjects are assigned to the groups by randomization. Methodologically, a so-called propensity score matching is used. Both groups are repeatedly interviewed before and after the intervention with the same instruments. In addition, the intervention group will be medically examined by the post-COVID outpatient clinic or the general practitioner as part of the assessment and their routine treatment.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group receiving no Post-/Long-COVID assessment Questionnaires at timepoints t1 (screening), t2 (before intervention), t3 (same time with the intervention/0 months after intervention), t4 (3 months after intervention), t5 (6 months after intervention)
Experimental: Intervention group receiving a Post-/Long-COVID assessment Questionnaires at timepoints t1 (screening), t2 (before intervention), t3 (same time with the intervention/0 months after intervention), t4 (3 months after intervention), t5 (6 months after intervention) Assessment in clinics for post-/long-COVID	Diagnostic Test: Psychological and Physiological Assessments About one third of the 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.

Arm

Intervention/Treatment

No Intervention: Control group receiving no Post-/Long-COVID assessment

Questionnaires at timepoints t1 (screening), t2 (before intervention), t3 (same time with the intervention/0 months after intervention), t4 (3 months after intervention), t5 (6 months after intervention)

Experimental: Intervention group receiving a Post-/Long-COVID assessment

Diagnostic Test: Psychological and Physiological Assessments

About one third of the 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.

Outcome Measures

Primary Outcome Measures

Developing and evaluating screening tools for Post-/Long-COVID [8 weeks]
Based on literature research a questionnaire examining physiological parameters indicative of Post-/Long-COVID will be designed.
Developing and evaluating a long-term and sustainable holistic treatment and support for patients diagnosed with post/long-COVID syndrome to prevent long-term illness and chronification. [4 months]
A physiological and psychological assessment examining Post-/Long-COVID will be designed based on reported indicators relevant for a Post-/ Long-COVID diagnosis. This assessment will be administered to the intervention group. The effectiveness in examining and correctly identifying Post-/ Long-COVID patients will be examined by comparing the assessment to the screening tool.
Evaluating the effectiveness of digital trainings [6 months]
Patients will receive individualized digital training plans after in order to improve on physiological as well as psychological parameters. The effectiveness of such digital trainings will be examined.
Symptom change with regard to Post-/ Long-COVID [7 months]
The symptom change with regard to Post-/Long-COVID will be evaluated by at least three follow-up measures. In addition, the psychological status, return to work and activities of daily living will be examined.

Secondary Outcome Measures

Return to Work [4 months]
Due to the interventions, return to work will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All people who are resident in Bavaria can participate. They must be of working age and have the ability to participate in surveys (e.g., sufficient German language skills). A willingness to participate in outpatient or (partially) inpatient therapy, the ability to undergo rehabilitation if necessary, and a telephone and Internet connection are prerequisites. There is a suspicion of post-/long-COVID.

Exclusion Criteria:

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