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Completed

NCT Number: NCT04011332

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

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.

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Key information

Conditions

COPD Exacerbation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8090, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Care Model

Other

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Nurse-led Integrated Care to Improve Quality of Life in COPD Patients With a Pulmonary Exacerbation

Acronym: NICCO

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2019
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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