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

An Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD (EmoD) - A Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: COPD Exacerbation
• Intervention / Treatment: Other: EmoD Intervention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela Schmid-Mohler, PD PhD; Phone Number: +41 44 255 20 03; Email: gabriela.schmid@usz.ch
• Study Contact Backup: Name: Christine Hübsch, PhD; Phone Number: +41 44 255 92 72; Email: christine.huebsch@usz.ch

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich
      • Contact: Christine Hübsch, PhD; Phone Number: +41 44 255 92 72; Email: christine.huebsch@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Inpatient on the pneumology or medical ward

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Other: EmoD Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach: Total number of patients who take up the programme	Number of patients who accept the study and / or intervention is documented by the study team.	Four months
Reach: Percentage of patients who take part in at least one outpatient intervention	Number of interventions per patient and number of patients with termination of the programme before Week 13 is documented by the ANP team	Four months
Reach: Reasons for participating in the programme (facilitators and barriers)	Patients who decline the intervention are asked by the ANP team and/or the study nurse for their reasons (barriers). The reasons for taking up the programme (facilitators) will be qualitatively investigated in interviews. A semi-structured interview guide will be used.	Four months
Reach: Reasons for ending (prematurely or on schedule) the programme (facilitators and barriers)	The reasons for ending (prematurely or on schedule) the programme will be qualitatively investigated in interviews. A semi-structured interview guide will be used.	Four months
Potential effectiveness: Change in depression	Quantitative Depression will be screened with the Hospital Anxiety and Depression Scale (HADS). The concept is measured with seven 4-point rating scales ranging from 0 to 3. The sum score ranging from 0 to 21 will be calculated (Zigmond & Snaith, 1983). Higher scores meaning worse outcomes. Differences between MZP1 and MZP2 will be calculated per subscore. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in anxiety	Quantitative Anxiety will be screened with the Hospital Anxiety and Depression Scale (HADS). The concept is measured with seven 4-point rating scales ranging from 0 to 3. The sum score ranging from 0 to 21 will be calculated (Zigmond & Snaith, 1983). Higher scores meaning worse outcomes. Differences between MZP1 and MZP2 will be calculated per subscore. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health-related quality of life (QoL)	Quantitative Health-related quality of life will be assessed with the Chronic Respiratory Questionnaire (CRQ) (Guyatt et al., 1987) following the defined procedure of the developers. 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 two weeks. A subscore for each domain (sum of items / number of items) will be calculated. The CRQ-SAS is available in German. It has demonstrated high sensitivity in the evaluation of a rehabilitation programme (Puhan et al., 2007). Differences between MZP1 and MZP2 will be calculated per subscore. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Patient satisfaction with programme	Quantitative The questionnaire on the quality of nursing care counseling (ANP-BQ) is used to assess patient satisfaction. This instrument includes, for example, a question to assess the satisfaction of care provided by the ANP on an NRS 1-10 (Petry et al., 2014; Weilenmann et al., 2021). Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Number of moderate exacerbations within 3 months	Quantitative The number of moderate exacerbations during the previous three months are assessed at week 14-17. For this purpose, moderate exacerbations are defined as an acute (more than normal day-to-day variation) worsening of respiratory symptoms (breathlessness, sputum and / or coughing) that are treated with systemic antibiotics and / or corticosteroids (systemic = oral or intravenous) (Global Initiative for Chronic Obstructive Lung Disease, 2019). Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Number of severe exacerbations within 3 months	Quantitative The number of severe exacerbations during the previous three months are assessed at week 14-17. For this purpose, severe exacerbations are defined as acute (more than normal day-to-day variation) worsening of respiratory symptoms (breathlessness, sputum and / or coughing) that result in hospitalisation or emergency room visit (Global Initiative for Chronic Obstructive Lung Disease, 2019). Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Rehospitalisation at day 90	Quantitative The number of COPD-related rehospitalisations after 3 months is assessed by medical chart review. Qualitative In the case of rehospitalisation, a one-to-one interview and medical chart review will be performed to assess reasons for rehospitalisation.	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).
Potential effectiveness: Time until first rehospitalisation	Quantitative The time until first rehospitalisation is assessed by medical chart review. Qualitative In the case of rehospitalisation, a one-to-one interview and medical chart review will be performed to assess reasons for rehospitalisation.	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).
Potential effectiveness: Change in health behaviour smoking- current status	Quantitative Smoking behaviour will be assessed by using the questionnaire from the WHO (Global Adult Tobacco Survey Collaborative Group, 2011). It assesses the current status of smoking (yes / no). Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour smoking - ex- smoker	Quantitative Smoking behaviour will be assessed by using the questionnaire from the WHO (Global Adult Tobacco Survey Collaborative Group, 2011). If an ex-smoker, it assesses date of smoking cessation (year). Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour smoking -smoker	Quantitative Smoking behaviour will be assessed by using the questionnaire from the WHO (Global Adult Tobacco Survey Collaborative Group, 2011). If a smoker, it assesses the substance and the number per day. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour nutrition - body weight	Quantitative Current body weight (kg) will be assessed. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour nutrition - body height	Quantitative Current body height (m) will be assessed. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour nutrition - BMI	Quantitative Current Body Mass Index (BMI) will be calculated according to the WHO recommendations (World Health Organization, 2000) (kg/m^2). Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour nutrition - NRS	Quantitative Current Nutritional Risk Screening (NRS) will be assessed during hospitalisation (Kondrup et al., 2003). 3 and more points meaning worse outcome. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour physical activity - C-PPAC	Quantitative Self-report by patient based on the first two items of the clinical version of PROactive Physical Activity in COPD instrument (C-PPAC). The items measure the amount of activity over the last 7 days with a range from 0-4. Higher scores meaning better outcomes. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour physical activity - PR	Quantitative The use of pulmonary rehabilitation/outpatient physiotherapy is recorded. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour inhalation adherence	Quantitative Adherence to inhalation will be assessed. The items were derived from the Zurich Assessment of Therapy Adherence CF (ZATA-CF) and adapted slightly. Patients are asked how often they needed to inhale the medication per day and how often they had skipped an inhalation in the past seven days. Higher scores meaning worse outcomes. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour action plan	Quantitative Availability of a prescription for an action plan (with/without self-medication) and adherence of patient to the action plan will be assessed. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Potential effectiveness: Change in health behaviour oxygen use	Quantitative Availability of an oxygen prescription and the patient's compliance with the prescription are assessed. Qualitative A semi-structured interview guide will be used based on the quantitative results.	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).
Implementation: Percent of programme components carried out according to the intervention manual	Quantitative Completed intervention components per patient were documented by the ANP team. Necessary but not or not fully completed parts of the intervention are also documented. Qualitative To understand reasons for performing, omitting or modifying components of the programme structured small group interviews will be conducted with HCP's involved in intervention delivery. The interview guide will be based on the results of the document analysis.	Data will be collected at the earliest six months after the start of the programme
Implementation: Acceptability of the programme	Quantitative The German translations of the Acceptability of Intervention Measure (AIM) scale will be used to assess the healthcare professional's perspective. The scale contains four items; all are rated on a 5-point response scale (1 = completely disagree, 5 = completely agree), we added a sixth option "no response" (0 points). Qualitative To understand reasons for the results structured small group interviews will be conducted with involved HCPs. The interview guide will be based on the results of the questionnaires.	Data will be collected at the earliest six months after the start of the programme
Implementation: Appropriateness of the programme	Quantitative The German translations of the Intervention Appropriateness Measure (IAM) scale will be used to assess the healthcare professional's perspective. The scale contains four items; all are rated on a 5-point response scale (1 = completely disagree, 5 = completely agree), we added a sixth option "no response" (0 points). Qualitative To understand reasons for the results structured small group interviews will be conducted with involved HCPs. The interview guide will be based on the results of the questionnaires.	Data will be collected at the earliest six months after the start of the programme
Implementation: Feasibility of the programme	Quantitative The German translations of the Feasibility of Intervention Measure (FIM) scale will be used to assess the healthcare professional's perspective. The scale contains four items; all are rated on a 5-point response scale (1 = completely disagree, 5 = completely agree), we added a sixth option "no response" (0 points). Qualitative To understand reasons for the results structured small group interviews will be conducted with involved HCPs. The interview guide will be based on the results of the questionnaires.	Data will be collected at the earliest six months after the start of the programme

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Feasibility study; Emotional distress; Mixed-methods design; Integrated care programme; APN
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2025-01178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No