Effects of the Clinical Application of Traditional, Complementary and Integrative Medicine (TCIM) Procedures During Inpatient Stays in Germany

Официальное название

Effects of the Clinical Application of TCIM Procedures During Inpatient Stays in Germany - a Multicenter Observational Study

Обзор

The aim of this healthcare research project is to evaluate the effects of routine inpatient TCIM (Traditional, Complementary and Integrative Medicine) care in Germany. The focus is on the TCIM centers at Immanuel Krankenhaus Berlin, Klinikum Bamberg und Evang. Kliniken Essen-Mitte, where inpatient TCIM therapies are to be systematically evaluated. This form of therapy, which is reimbursed by statutory health insurance providers (under certain conditions), is based on a combination of various evidence-based TCIM approaches. These include hyperthermia, exercise therapy, Mind-Body Medicine, phytotherapy, nutritional therapy, fasting therapy inter alia.

Вмешательства

• Другое Inpatient TCIM therapy
  This multicenter, prospective, uncontrolled observational study is evaluating the effects and safety of inpatient TCIM therapy (German: naturheilkundliche Komplextherapie) at three German clinics: Immanuel Hospital Berlin, Klinikum Bamberg, and Evangelical Clinics Essen-Mitte. This therapy, reimbursed by statutory health insurance under certain conditions, combines evidence-informed TCIM approaches such as hyperthermia, exercise therapy, phytotherapy, and dietary interventions including fasting

Первичные конечные точки

• Short Form Health Survey - 12 Items (SF-12) [Срок оценки: Baseline, 3 months]

Вторичные конечные точки (12)

• Short Form Health Survey - 12 Items (SF-12) [Срок оценки: Baseline, up to 14 days, 6 months, 12 months]
• EuroQol 5-Dimension 5-Level [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• Food Frequency List [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• International Physical Activity Questionnaire - Short Form [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• Hospital Anxiety and Depression Scale [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• Work Productivity and Activity Impairment Questionnaire [Срок оценки: Baseline, 3 months, 6 months, 12 months]
• Perceived Stress Scale - 4 [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• Main complaint [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• Fibromyalgia Impact Questionnaire [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• Rheumatoid Arthritis Disease Activity Index [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• Bath Ankylosing Spondylitis Disease Activity Index [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]
• Bath Ankylosing Spondylitis Functional Index [Срок оценки: Baseline, up to 14 days, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

• Beginning (first 24 hours) inpatient TCIM treatment at Immanuel Hospital Berlin, Bamberg Hospital, or Evangelische Kliniken Essen-Mitte
• Written consent form

Критерии исключения

• Insufficient language skills
• Dementia or other severely impairing cognitive disorders
• Pregnancy or breastfeeding
• Participation in a clinical study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 3 центра

• Sozialstiftung Bamberg, Klinikum Bamberg — Bamberg
• Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus, Institut für Sozialm — Berlin
• Klinik für Naturheilkunde und Integrative Medizin, KEM — Essen

Идентификаторы

NCT: NCT07040475 · Minerva

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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