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Clinical Trials/NCT07351929
NCT07351929
Recruiting
Not Applicable

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

University of Zurich1 site in 1 country20 target enrollmentStarted: January 12, 2026Last updated:
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InterventionsEmoD Intervention

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Change in COPD-related emotional distress (CRED)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)
  • •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

Arms & Interventions

Intervention Group

Experimental

Intervention: EmoD Intervention (Other)

Outcomes

Primary Outcomes

Change in COPD-related emotional distress (CRED)

Time Frame: 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)

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

  • 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 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(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)(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(Data will be collected at the earliest six months after the start of the programme)
  • Implementation: Acceptability of the programme(Data will be collected at the earliest six months after the start of the programme)
  • Implementation: Appropriateness of the programme(Data will be collected at the earliest six months after the start of the programme)
  • Implementation: Feasibility of the programme(Data will be collected at the earliest six months after the start of the programme)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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