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

NCT04011332 | Completed

• 1 other identifier: 2019-00797
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

integrated care; self-management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Other: Integrated Care Model

Control Group

NO INTERVENTION

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment (dementia, delirium)
• Not speaking German, French, Italian, English, Spanish, Portuguese, Serbian, Tamil, Hindi, Turkish or Slovakian

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8090, Switzerland

Location

Related Publications (1)

• Schmid-Mohler G, Hubsch C, Braun J, Steurer-Stey C, Aregger C, Schaer DJ, Clarenbach C. Effect of a nurse-led integrated care intervention on quality of life and rehospitalisation in patients with severe exacerbation of COPD-a pilot study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241291067. doi: 10.1177/14799731241291067.

  PMID: 39407408 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: monocentric parallel cluster design with a baseline period

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 8, 2019
• Study Start: July 4, 2019
• Primary Completion: March 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)