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Active, Not Recruiting

NCT Number: NCT07524023

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

COPD COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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)]

    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).

Secondary outcomes

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

    Time frame: Four months

    Percentage of patients approached who take up the programme

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

    Time frame: Four months

    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

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

    Time frame: Four months

    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.

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

    Time frame: Four months

    The reasons for ending (prematurely or on schedule) the programme will be qualitatively investigated in interviews. A semi-structured interview guide will be used

  5. Potential effectiveness: Change in depression

    Time frame: 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).

    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.

  6. Potential effectiveness: Change in anxiety

    Time frame: 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).

    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.

  7. Potential effectiveness: Change in health-related quality of life (*QoL*)

    Time frame: 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).

    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.

  8. Potential effectiveness: Patient satisfaction with programme

    Time frame: 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).

    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.

  9. Potential effectiveness: Number of moderate exacerbations within 3 months

    Time frame: 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).

    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.

  10. Potential effectiveness: Number of severe exacerbations within 3 months

    Time frame: 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).

    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.

  11. Potential effectiveness: Rehospitalisation at day 90

    Time frame: 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).

    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.

  12. Potential effectiveness: Change in health behaviour smoking- current status

    Time frame: 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).

    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.

  13. Potential effectiveness: Change in health behaviour smoking - ex- smoker

    Time frame: 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).

    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.

  14. Potential effectiveness: Change in health behaviour smoking -smoker

    Time frame: 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).

    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.

  15. Potential effectiveness: Change in health behaviour nutrition - body weight

    Time frame: 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).

    Quantitative

    Current body weight (kg) will be assessed.

    Qualitative

    A semi-structured interview guide will be used based on the quantitative results.

  16. Potential effectiveness: Change in health behaviour nutrition - body height

    Time frame: 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).

    Quantitative

    Current body height (m) will be assessed.

    Qualitative

    A semi-structured interview guide will be used based on the quantitative results.

  17. Potential effectiveness: Change in health behaviour nutrition - BMI

    Time frame: 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).

    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.

  18. Potential effectiveness: Change in health behaviour nutrition - NRS

    Time frame: 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).

    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.

  19. Potential effectiveness: Change in health behaviour physical activity - C-PPAC

    Time frame: 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).

    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:

  20. Potential effectiveness: Change in health behaviour physical activity - Pulmonary rehabilitation

    Time frame: 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).

    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.

  21. Potential effectiveness: Change in health behaviour inhalation adherence

    Time frame: 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).

    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.

  22. Potential effectiveness: Change in health behaviour action plan

    Time frame: 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).

    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.

  23. Potential effectiveness: Change in health behaviour oxygen use

    Time frame: 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).

    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.

  24. Implementation: Percent of programme components carried out according to the intervention manual

    Time frame: Six months

    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.

  25. Implementation: Acceptability of the programme

    Time frame: Six months

    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.

  26. Implementation: Appropriateness of the programme

    Time frame: Six months

    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.

  27. Implementation: Feasibility of the programme

    Time frame: Six months

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: EmoD-2

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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