Emotional-distress-based Integrated Care Programme in Patients With Stable COPD (EmoD-2)

Emotional-distress-based Integrated Care Programme in Patients With Stable COPD - A Feasibility Study (EmoD-2)

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.

Study Overview

• Status: Recruiting
• Conditions: COPD; COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Other: EmoD Intervention

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

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

Exclusion Criteria:

• 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)
• Unstable psychiatric situation, i.e., current psychiatric treatment due to personality disorder, schizophrenia, drug use, suicidal tendencies. No exclusion for nicotine and alcohol abuse, anxiety, and depression
• Not speaking or reading German
• Intervention via telephone or video call not possible
• Lung transplant (recipient or candidate)

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: EmoD Intervention	Other: EmoD Intervention; 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.

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 (Baseline measurement, week 0-4), and follow-up, three months after (week 14-17)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach: Total number of patients who take up the programme	Percentage of patients approached who take up the programme	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 advanced practice nursing team	Four months
Reach: Reasons for participating in the programme (facilitators and barriers)	Patients who decline the intervention are asked by 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. Higher scores mean worse outcomes. Differences between MZP1 and MZP2 will be calculated per subscale. 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 measurements will be applied in the first month (week 0-4). Second measurement 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. Higher scores mean worse outcomes. Differences between MZP1 and MZP2 will be calculated per subscale. 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 measurements will be applied in the first month (week 0-4). Second measurement 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*), following the defined procedure of the developers. The self-administered questionnaire version with standardised dyspnoea 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. Differences between baseline measurement and second measurement 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 measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).
Potential effectiveness: Patient satisfaction with programme	Quantitative: The questionnaire on the quality of nursing care counselling (*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. 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 measurements will be applied in the first month (week 0-4). Second measurement 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 weeks 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). 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 measurements will be applied in the first month (week 0-4). Second, measurement 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 weeks 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. 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 measurements will be applied in the first month (week 0-4). Second measurement 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 measurements will be applied in the first month (week 0-4). Second, measurement 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. 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 measurements will be applied in the first month (week 0-4). Second, measurement 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. 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 measurements will be applied in the first month (week 0-4). Second, measurement 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. 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 measurements will be applied in the first month (week 0-4). Second measurement 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 measurements will be applied in the first month (week 0-4). Second measurement 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 measurements will be applied in the first month (week 0-4). Second measurement 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 (kg/m²). 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 measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).
Potential effectiveness: Change in health behaviour nutrition - NRS	Quantitative: The current nutritional risk screening (*NRS*) will be assessed during hospitalisation. Three and more points means a 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 measurements will be applied in the first month (week 0-4). Second measurement 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 mean 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 measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).
Potential effectiveness: Change in health behaviour physical activity - Pulmonary rehabilitation	Quantitative The use of pulmonary rehabilitation (*PR*) /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 measurements will be applied in the first month (week 0-4). Second measurement 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 mean 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 measurements will be applied in the first month (week 0-4). Second measurement 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 patients 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 measurements will be applied in the first month (week 0-4). Second measurement 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 measurements will be applied in the first month (week 0-4). Second measurement 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.	Six months
Implementation: Acceptability of the programme	Quantitative: The German translation 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). The investigators 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.	Six months
Implementation: Appropriateness of the programme	Quantitative: The German translation 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). The investigators 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.	Six months
Implementation: Feasibility of the programme	Quantitative The German translation 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). The investigators 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.	Six months

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility study; copd; Emotional Distress; Mixed-methods design; APN; Integrated care prgramme
• 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: 2025-02396

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