Randomized controlled feasibility study on an outpatient telemedicine integrative care approach for acute bronchitis patients

Early Phase 1

• Conditions: J20; Acute bronchitis

• Registration Number: DRKS00033113
• Lead Sponsor: niversitätsklinik Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Acute bronchitis (diagnosis by primary care physician according to guideline).
2. Onset of symptoms (cough and/or fever > 37.9o C and/or other bronchitis symptoms) < 3 days
3. Signed informed consent by the patient
4. Ability to understand study procedures
5. Age from 18 years old.
6. Equipped to attend telemedicine encounters (smartphone / tablet / laptop / ...)

Exclusion Criteria

1. Bronchitis-like symptoms are primarily attributed to another medical condition, e.g., pertussis, lung cancer, gastroesophageal reflux, heart failure, pulmonary embolism, allergic bronchial asthma, pulmonary tuberculosis
2. Antibiotic treatment during the last 2 weeks
3. Suspected pneumonia
4. Severe cardiac, pulmonary, renal, hepatic insufficiency.
5. Severe psychiatric illness or substance abuse that interferes with protocol- appropriate cooperation
6. Immunosuppression
7. Skin disease that precludes the use of wraps and baths
8. Pregnancy or breastfeeding
9. Participation in another clinical trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bronchitis Severity Score (BSS) day 7

Secondary Outcome Measures

Name	Time	Method
• Wisconsin Upper Respiratory Symptom Survey – 21 (day 1-14)<br>• Body temperature (day 1-14)<br>• Quality of Life (EQ-5D, day 1, 4, 7, 14)<br>• Hospitalization rate (during 14/28 days)<br>• Doctor's visits (during 14/28 days)<br>• Prescription of antibiotics, analgesics, anti-inflammatory drugs (during 7/14/28 days)<br>• Use of integrative care measures (day 7)<br>• Patient satisfaction (day 14)<br>• Days of absence from work / school / studies (during 28 days)<br>• Only feasibility trial: Comprehensibility of instructions (day 7)<br>• Only feasibility trial: Feasibility of study procedures and detection of necessary adaptions