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临床试验/NCT05238415
NCT05238415已完成不适用

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

Prof. Dr. Sonia Lippke2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2021年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
192
试验地点
2
主要终点
Change from baseline in the Post-/ Long-COVID symptoms at 3 months

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Control group receiving no Post-/Long-COVID assessment

No Intervention

Questionnaires at timepoints t1 (screening), t2 (one week later), t3 (before the intervention), t4 (after the intervention), t5 (6 weeks after intervention), t6 (6 months after the intervention)

Patients from Bavaria Germany: Contact to personal pilots and digital health interventions.

Intervention group receiving a Post-/Long-COVID assessment

Experimental

Questionnaires at timepoints t1 (screening), t2 (one week later), t3 (before the intervention), t4 (after the intervention), t5 (6 weeks after intervention), t6 (6 months after the intervention)

Patients from Bavaria Germany: Assessment in clinics for post-/long-COVID, contact to personal pilots and digital health interventions.

干预措施: Psychological and Physiological Assessments (Diagnostic Test)

Comparison group receiving no Post-/Long-COVID assessment

No Intervention

Questionnaires at timepoints t1 (screening), t2 (comparable to t2 in the other groups), t3 (comparable with t4 in the other groups), t3 (comparable to t5 in the other groups)

Patients from Germany: No intervention at all

结局指标

主要结局

Change from baseline in the Post-/ Long-COVID symptoms at 3 months

时间窗: Baseline to 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)

Subjective prognosis of return to work

时间窗: 2 weeks, 8 weeks

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.

次要结局

  • Activity and social participation(2 weeks, 8 weeks)
  • Health behaviors of daily living(2 weeks, 8 weeks)
  • Life satisfaction(2 weeks, 8 weeks)
  • Mental health(2 weeks, 8 weeks)

研究者

发起方
Prof. Dr. Sonia Lippke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Sonia Lippke

Professor of Health Psychology and Behavioral Medicine

Jacobs University Bremen gGmbH

研究点 (2)

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