Psychological Distress Clinical Trial
— ASAPOfficial title:
ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan
NCT number | NCT05238415 |
Other study ID # | ASAP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 15, 2021 |
Est. completion date | June 30, 2023 |
Verified date | August 2023 |
Source | Jacobs University Bremen gGmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 192 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Germany | Dr. Becker Klinikgruppe | Cologne |
Lead Sponsor | Collaborator |
---|---|
Prof. Dr. Sonia Lippke | Dr. Becker Clinic Möhnesee, Dr. Becker Hospital Group, Dr. Becker Kiliani Clinic, Johannesbad Reha Clinics Bad Füssing, Reha-Centre Bad Kötzting |
Germany,
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- Dahmen A, Gao L, Keller FM, Becker P & Lippke S. Psychosomatische Nachsorge: Curriculum Hannover online vs. Curriculum Hannover und vs. Care as Usual. Vortrag im Rahmen des DRV-Kolloquiums 2021.
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the Post-/ Long-COVID symptoms at 3 months | The symptom change with regard to Post-/Long-COVID will be evaluated by at least three follow-up measures, using a questionnaire adapted from the COVID-19 Rehabilitation Needs Questionnaire-Health Problems caused by SARS-CoV-2 (Lemhöfer, C., et al. (2021)), with 14 items. Possible scores range from 1 (no problem) to 5 (extreme problem). Change = (Score at measurement points (e.g.,3 months) - Score at baseline) | Baseline to 3 months | |
Primary | Subjective prognosis of return to work | Return to work will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The questionnaire is adapted to the context of COVID-19 from the SPE scale (Mittag, O., & Raspe, H. (2003)), with 4 items. | 2 weeks, 8 weeks | |
Secondary | Activity and social participation | Social participation will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline), using a questionnaire adapted from the COVID-19 Rehabilitation Needs Questionnaire-Activity and participation (Lemhöfer, C., et al. (2021)), with 12 items. Possible scores range from 1 (Never) to 5 (Often/always). | 2 weeks, 8 weeks | |
Secondary | Health behaviors of daily living | Health behaviors of daily living including physical activity and nutrition consumption behavior, and sedentary behavior will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The physical activity and nutrition consumption questionnaire is adapted from the Physical Activity and Fruit and Vegetable Consumption Questionnaire (Lippke, S., et al. (2009)), with 2 items. The sedentary behavior questionnaire is adapted from the International Physical Activity Questionnaire (Craig, C. L.,et al. (2003)), with 2 Items. | 2 weeks, 8 weeks | |
Secondary | Mental health | Mental health including loneliness, psychological distress, stress, depression and anxiety will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The loneliness questionnaire is adapted from the UCLA loneliness scale (Russell, D. (1996)), with 2 items. The psychological distress will be assessed by Peri-traumatic Distress Scale (Qiu, J. et al. (2020)), with 24 items. The stress questionnaire is adapted from the PSS-4 (Cohen, S. (1988)), with 4 items. The depression and anxiety questionnaire is adapted from the PHQ-4 (Löwe, B.,et al. (2010)), with 4 items. | 2 weeks, 8 weeks | |
Secondary | Life satisfaction | Life satisfaction will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline), using a questionnaire adapted from the General Satisfaction with Life Questionnaire (Beierlein, C., et al. (2015)), with 4 items. Possible scores range from 1 (totally unsatisfied) to 4 (very satisfied). | 2 weeks, 8 weeks |
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