Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

NCT07351929 | Recruiting

• 1 other identifier: 2025-01178
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have developed a new counseling service that focuses on the emotional distress experienced by people living with COPD. The service has been specially developed for patients who have experienced a deterioration in their lung condition (known as an acute exacerbation of COPD). The new program is led by an APN team. Other professionals are involved in the program, such as medical staff and physiotherapists. The new counseling service lasts three months. Patients will receive ten counseling sessions with a specialized nurse. The overall objective of the study is to assess the feasibility of the newly developed emotional-distress-based integrated care programme.

Conditions

COPD Exacerbation

Keywords

COPD; Feasibility study; Mixed-methods design; Emotional distress; Integrated care programme; APN

Outcome Measures

Primary Outcomes (1)

• Change in COPD-related emotional distress (CRED)

  Change in COPD-related emotional distress between baseline and month 3. COPD-related emotional distress will be assessed using the newly developed 'COPD-Related Emotional Distress Questionnaire (CRED)', which was developed for CF and COPD patients (publication in progress; former name of the questionnaire: IRED-RESP). The questionnaire includes 36 items and assesses distress related to symptoms, treatment, restrictions in range of mobility and participation in social life, unpredictability of the disease, and stigma, using a 5-point Likert scale. Higher scores mean more emotional distress (worse outcome).

  Quantitative data will be collected baseline, in the first month after hospitalization due to AECPOD (MZP 1, week 0-4), and follow-up, three months after (MZP2, week 14-17)

Secondary Outcomes (28)

• Reach: Total number of patients who take up the programme

  Four months

• Reach: Percentage of patients who take part in at least one outpatient intervention

  Four months

• Reach: Reasons for participating in the programme (facilitators and barriers)

  Four months

• Reach: Reasons for ending (prematurely or on schedule) the programme (facilitators and barriers)

  Four months

• Potential effectiveness: Change in depression

  Study duration per patient is three months with two measurement points. Baseline measurement (MZP1) will be applied in the first month after hospitalization due to AECPOD (week 0-4). Second measurement (MZP 2) will take place in month four (week 14-17).

Study Arms (1)

Intervention Group

EXPERIMENTAL

Other: EmoD Intervention

Interventions

EmoD Intervention OTHER

Patients who are hospitalised due to a COPD exacerbation will be aligned to a nurse-led emotional-distress-based integrated care programme for 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
• Inpatient on the pneumology or medical ward

You may not qualify if:

• Cognitive impairment (dementia, delirium) (DOS\>3 or AES\>6 or Mini-Cog\<3)
• Unstable psychiatric disorders
• Not speaking German
• Lung transplant
• Pneumonia caused by chronic colonization by bacteria (Legionella, nontuberculous mycobacteria (NTM))
• Unable to telephone

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gabriela Schmid-Mohler, PD PhD

CONTACT

+41 44 255 20 03; gabriela.schmid@usz.ch

Christine Hübsch, PhD

CONTACT

+41 44 255 92 72; christine.huebsch@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Explanatory sequential mixed-methods design

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 20, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)