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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04011332
Other study ID # 2019-00797
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 4, 2019
Est. completion date April 30, 2023

Study information

Verified date May 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate the effect and effectiveness of the nurse-led integrated care programme for the management of COPD (Chronic Obstructive Pulmonary Disease) exacerbations on patients' quality of life, rehospitalisation and exacerbation rate, illness-related emotional distress, selected health behaviours and cost-utility at three months. Furthermore, understanding barriers and facilitators to implementation success is of interest.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date April 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with a confirmed diagnosis of COPD (GOLD 1-4) - Hospitalisation due to a COPD exacerbation and decision to start with steroids and/or antibiotics (severe exacerbation) - Age = 18 Exclusion Criteria: - Cognitive impairment (dementia, delirium) - Not speaking German, French, Italian, English, Spanish, Portuguese, Serbian, Tamil, Hindi, Turkish or Slovakian

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Integrated Care Model
The patients who are hospitalised due to a COPD exacerbation will be aligned to a nurse-led integrated care model for three months. The model constitutes a bundle of interventions that are commonly known as key elements in COPD management. In addition, the ANP-Team (Advanced Nursing Practice-Team) will coordinate the different health professionals within the hospital and across transitions within the three months.

Locations

Country Name City State
Switzerland University Hospital Zurich Zürich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in CRQ (Chronic Respiratory Questionnaire) scores Change in the four CRQ (Chronic Respiratory Questionnaire) subscores from week 1 to 13. The self-administered questionnaire version with standardised dyspnea questions (SAS) will be used. The questionnaire was developed for patients with chronic airflow limitations and comprises 20 items which assess four domains: 1) dyspnea, 2) fatigue, 3) emotional function and 4) mastery. The scoring scale ranges from 1 (extreme) to 7 (not at all) and will be assessed with a recall period of the past 2 weeks. A subscore for each domain (sum of items / number of items) will be calculated. at week one and week 13
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