Emotional-distress-based Integrated Care Programme in Patients With Stable COPD

NCT07524023 | Recruiting

• 1 other identifier: 2025-02396
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have developed a new counselling service that focuses on the emotional distress experienced by people living with chronic obstructive pulmonary disease (\*COPD\*). The new programme is led by an advanced practice nursing (\*APN\*) team. Other professionals are involved in the programme, such as medical staff and physiotherapists. The new counselling service lasts three months. Patients will receive ten counselling 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; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

copd; Feasibility study; Mixed-methods design; Emotional Distress; Integrated care prgramme; 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 (Baseline measurement, week 0-4), and follow-up, three months after (week 14-17)]

Secondary Outcomes (27)

• 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 measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).

Study Arms (1)

EmoD Intervention

EXPERIMENTAL

Other: EmoD Intervention

Interventions

EmoD Intervention OTHER

Outpatients in a stable phase of chronic pulmonary disease (\*COPD\*) will be aligned to a nurse-led emotional-distress-based integrated care programme for three months.

EmoD Intervention

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) and existing lung function in the past 12 months
• Age ≥ 18
• Outpatient treatment on the pneumology clinic of the university hospital Zurich. Last consultation within the past 12 months

You may not qualify if:

• Significant changes in symptoms over the past 3 months that exceeded the everyday fluctuations and required intensification of treatment (moderate, severe exacerbations or pneumonia) and no COPD-related hospitalisation in the past 3 months
• Cognitive impairment (dementia, delirium)
• Not speaking or reading German
• Intervention via telephone or video call not possible
• Lung transplant (recipient or candidate)

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: February 27, 2026
• First Posted: April 13, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)