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

Organizational Data

DRKS-ID:
DRKS00033113
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2023-11-27
Last update in DRKS:
2023-11-27
Registration type:
Prospective

Acronym/abbreviation of the study

pilot-AIM-BroTher

URL of the study

No Entry

Brief summary in lay language

With the current study, we would like to examine how a study project on telemedically mediated care measures can be carried out. It is therefore a pilot or feasibility study. In this study, patients are randomized to 2 study arms. In one study arm, patients receive treatment from their GP practice. In the second study arm, patients also receive telemedical instructions on teas, foot baths and compresses, as well as advice on general measures and lifestyle. The treatment is carried out over 7 days.

Brief summary in scientific language

In this pilot trial we want to investigate a telemedicinal integrative medicine care concept for patients with acute bronchitis in an outpatient setting. The pilot trial is preparatory for a confirmative effectiveness trial. With this trial we want to contribute to reducing non-indicated antibiotic treatment and to improve the management of acute bronchitis, we want to increase patient education and patient self- management and empowerment. Furthermore, we want to close the research gap of integrative medicine measures which are often recommended in acute bronchitis despite the lack of systematical evidence for these measures.

Health condition or problem studied

ICD10:
J20 - Acute bronchitis
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Integrative telemedicinal outpatient care concept: (adapted to the main complaints of the patients). Patients are contacted on day 1, 2 and 4 via telemedicine by a nurse practitioner. They are asked about their main complaints, which are documented in a symptom diary and a treatment plan is set up. Treatment elements include wraps, baths, teas etc.. These measure are explained to the patient in a way that he/she will be able to carry them out by him/herself. Dietary and lifestyle measures are discussed.
Arm 2:
Standard of Care

Endpoints

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

Study Design

Purpose:
Supportive care
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
0
Study type:
Interventional
Mechanism of allocation concealment:
For allocation of the participants, a computer-generated list of random numbers will be used. The list will be accessible by an independent researcher only and randomization will be performed from this list for each individual patient after inclusion in the study.
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
Computer-generated list of random numbers.
Who is blinded:
  • Data analyst

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Doctor's practice Freiburg im Breisgau
  • Doctor's practice Waldkirch

Recruitment period and number of participants

Planned study start date:
2024-10-01
Actual study start date:
No Entry
Planned study completion date:
2025-01-31
Actual Study Completion Date:
No Entry
Target Sample Size:
30
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

Addresses

Primary Sponsor

Universitätsklinik Freiburg
Dr. med. Paul G. Werthmann
Hugstetter Str.
55 Freiburg im Breisgau
Germany
Telephone:
+49 (0) 7 61 / 2 70 82
Fax:
+49 (0) 7 61 / 2 70 83
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/naturheilkunde/uni-zentrum-naturheilkunde.html
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinik Freiburg
Dr. med. Paul G. Werthmann
Hugstetter Str.
55 Freiburg im Breisgau
Germany
Telephone:
+49 (0) 7 61 / 2 70 82
Fax:
+49 (0) 7 61 / 2 70 83
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/naturheilkunde/uni-zentrum-naturheilkunde.html

Contact for Public Queries

Universitätsklinik Freiburg
Dr. med. Paul G. Werthmann
Hugstetter Str.
55 Freiburg im Breisgau
Germany
Telephone:
+49 (0) 7 61 / 2 70 82
Fax:
+49 (0) 7 61 / 2 70 83
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/naturheilkunde/uni-zentrum-naturheilkunde.html

Principal Investigator

Universitätsklinik Freiburg
Dr. med. Paul G. Werthmann
Hugstetter Str.
55 Freiburg im Breisgau
Germany
Telephone:
+49 (0) 7 61 / 2 70 82
Fax:
+49 (0) 7 61 / 2 70 83
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/naturheilkunde/uni-zentrum-naturheilkunde.html

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Deutsche Forschungsgemeinschaft
Kennedyallee 40
53175 Bonn
Germany
Telephone:
+49 (228) 885-1
Fax:
+49 (228) 885-2777
Contact per E-Mail
URL:
http://www.dfg.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072500
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de/ethikkommission.html

Vote of leading Ethics Committee

Date of ethics committee application:
2023-05-24
Ethics committee number:
23-1259-S1
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-10-26

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
518861286 - Deutsche Forschungsgemeinschaft
Other secondary IDs:
FRKS004690 - Freiburger Register Klinischer Studien
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
The deidentified dataset of this clinical trial will be shared publicly together with other documents of the trial. The dataset will contain all of the individual participant data collected during the trial, after deidentification. It will be shared immediately following the publication of the trial results. It will be shared with anyone who wishes to access the data.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry