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COPDEmoD-2NCT07524023

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

A study testing EmoD Intervention in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by University of Zurich at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EmoD Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSwitzerland
Study dates
16 Mar 2026to 10 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital Zürich

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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.

Being tested
EmoD Intervention
Keywords
copd, Feasibility study, Mixed-methods design, Emotional Distress, Integrated care prgramme, APN
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmoD InterventionOther

    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.

Study groups in NCT07524023
Study groupRoleWhat they receive
EmoD InterventionExperimentalNot described
Receives: Other: EmoD Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)
  1. Reach: Total number of patients who take up the programme

    Percentage of patients approached who take up the programme

    Measured: Four months

  2. 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

    Measured: Four months

  3. 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.

    Measured: Four months

  4. 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

    Measured: Four months

  5. 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.

    Measured: 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).

  6. 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.

    Measured: 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).

  7. 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.

    Measured: 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).

  8. 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.

    Measured: 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).

  9. 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.

    Measured: 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).

  10. 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.

    Measured: 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).

  11. 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.

    Measured: 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).

  12. 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.

    Measured: 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).

  13. 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.

    Measured: 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).

  14. 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.

    Measured: 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).

  15. 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.

    Measured: 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).

  16. 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.

    Measured: 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).

  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.

    Measured: 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).

  18. 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.

    Measured: 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).

  19. 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:

    Measured: 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).

  20. 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.

    Measured: 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).

  21. 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.

    Measured: 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).

  22. 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.

    Measured: 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).

  23. 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.

    Measured: 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).

  24. 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.

    Measured: Six months

  25. 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.

    Measured: Six months

  26. 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.

    Measured: Six months

  27. 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.

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start16 Mar 2026
  3. Primary completion10 Sep 2026 (estimated)
  4. Study completion10 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Explanatory sequential mixed-methods design
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07524023
Sponsor's protocol ID
2025-02396
Other IDs
2025
Acronym
EmoD-2
Status last verified
Jun 2026
First submitted
27 Feb 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EmoD Intervention in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in COPD-related emotional distress (CRED) (time frame: Quantitative data will be collected baseline, in the first month (Baseline measurement, week 0-4), and follow-up, three months after (week 14-17)]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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