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Nurse-led Integrated Care in COPD Patients With a Pulmonary Exacerbation (NICCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011332
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Other: Integrated Care Model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: monocentric parallel cluster design with a baseline period
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Nurse-led Integrated Care to Improve Quality of Life in COPD Patients With a Pulmonary Exacerbation
Estimated Study Start Date : July 4, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Intervention Group 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.

No Intervention: Control Group



Primary Outcome Measures :
  1. Change in CRQ (Chronic Respiratory Questionnaire) scores [ Time Frame: at week one and week 13 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011332


Contacts
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Contact: Gabriela Schmid-Mohler +41442552003 ext +41442552003 gabriela.schmid@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Switzerland, 8090
Contact: Gabriela Schmid-Mohler, PhD    ++41 44 255 20 03    gabriela.schmid@usz.ch   
Sponsors and Collaborators
University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04011332    
Other Study ID Numbers: 2019-00797
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
integrated care
self-management