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Integrating Palliative Care Education in Pulmonary Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06046547
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : January 30, 2024
Sponsor:
Collaborator:
Centro Hospitalar do Baixo Vouga
Information provided by (Responsible Party):
Alda Sofia Pires de Dias Marques, Aveiro University

Brief Summary:

Living with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) imposes enormous daily challenges, especially at advanced stages, not just to patients but also to informal caregivers. Their needs are not fully addressed by disease-modifying treatments. A key strategy to improve their well-being is the early integration of palliative care into routine management of COPD and ILD. Pulmonary rehabilitation (PR), one of the most well-established and cost-effective interventions in chronic respiratory diseases may be a suitable venue for this approach.

The main goal of this randomised controlled study is to explore the effects of palliative care education as part of PR in people with COPD or ILD and informal caregivers. The primary question to be addressed is: "Does integrating education about palliative care in PR improve knowledge on this subject?".

The investigators will compare PR with palliative care education (experimental) with traditional PR (control) in people with COPD or ILD and informal caregivers. The intervention will include an education session about palliative care, a "Peer-to-peer session", a "Get-apart session" and online sessions. A mixed-methods approach will be used to evaluate the outcomes.

This study will provide an evidence-based insight into personalised PR with palliative care education for people with COPD or ILD and informal caregivers.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Interstitial Lung Disease Other: Pulmonary rehabilitation integrating education about palliative care Other: Pulmonary rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrating Palliative Care Education in Pulmonary Rehabilitation
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026


Arm Intervention/treatment
Experimental: Pulmonary rehabilitation with palliative care education
The experimental group will participate in PR with palliative care education.
Other: Pulmonary rehabilitation integrating education about palliative care

PR will include exercise training twice a week, and education and psychosocial support once per week during 12 weeks.

The intervention will include an education session on palliative care, a "Peer-to-peer session", a "Get-apart session" and online sessions.

The education session on palliative care will be facilitated by two specialist healthcare professionals. The main topics that will be discussed are: concept of palliative care, symptom control, disease impact, psychosocial support and planning for the future.

Participants will be the primary communicators in the "Peer-to-peer session", and the dialogue will be based on their suggestions. Those who feel more reluctant to reveal private thoughts in front of their loved ones will have the opportunity to discuss their issues in a "Get-apart" environment.

Individual cases will be referred to a specialist palliative care team or to any other health/social care professional according to the unmet needs identified.


Active Comparator: Pulmonary rehabilitation
The control group will participate in traditional PR.
Other: Pulmonary rehabilitation
Participants will receive the same PR program as the experimental group besides the education session on palliative care, the "Peer-to-peer session", the "Get-apart session" and the online sessions (i.e. traditional pulmonary rehabilitation).




Primary Outcome Measures :
  1. Knowledge about palliative care: Palliative Care Knowledge Scale (PaCKS) [ Time Frame: Assessment at baseline, at 12-weeks (i.e., end of PR) and at 6 months after PR. ]

    PaCKS is a 13-item questionnaire assessing a broad range of topics, including goals, target population and timing of palliative care, as well as symptoms and problems that palliative care addresses. For each statement, "True", "False" and "I don't know" options are provided, and a mark is given for each correct answer. Total scores range from 0 to 13 and higher scores indicate higher knowledge.

    It will be evaluated in people with COPD or ILD and informal caregivers.



Secondary Outcome Measures :
  1. Attitude towards palliative care referral: "Would you (your loved one) like to be referred to a specialist palliative care team at this time?" [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]
    Possible answers: "Yes", "No" and "I don't know". It will be evaluated in people with COPD or ILD and informal caregivers.

  2. Attitude towards palliative care referral: "Would you (your loved one) like to be referred to a specialist palliative care team if your (your loved one') health deteriorates?" [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]
    Possible answers: "Yes", "No" and "I don't know". It will be evaluated in people with COPD or ILD and informal caregivers who do not answer "Yes" to the previous question.

  3. Pain: "Do you feel pain?" [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    Participants will be asked about pain perception with a closed question: "Do you feel pain?". In affirmative cases, pain charts and visual analogue scale will be used to identify its location and to measure its intensity, respectively. Scores will be recorded on a 10 centimetres line that represents a continuum between "no pain" and "worst pain".

    It will be evaluated in people with COPD or ILD and informal caregivers.


  4. Dyspnoea: modified Medical Research Council questionnaire (mMRC) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    mMRC is a 5-point scale graded from 0 ("No breathlessness except on strenuous exercise") to 4 ("Too breathless to leave the house or breathless when dressing or undressing"). Higher scores indicate greater dyspnoea severity on daily activities.

    It will be evaluated in people with COPD or ILD.


  5. Fatigue: Fatigue Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-FS) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    FACIT-FS is a 13-item questionnaire assessing tiredness, weakness, listlessness, lack of energy, and their impact on HRQoL. Each item is rated from 0 ("Not at all") to 4 ("Very much"). Total score ranges from 0 to 52. Higher scores indicate less fatigue.

    It will be evaluated in people with COPD or ILD and informal caregivers.


  6. Cough: Leicester Cough Questionnaire (LCQ) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    LCQ is a 19-item questionnaire containing three domains: physical, psychological and social. Each item is rated from 1 to 7. Final score ranges from 3 to 21. Higher scores indicate weaker influence of cough on quality of life.

    It will be evaluated in people with COPD or ILD.


  7. Anxiety and depression: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    HADS includes 14 multiple-choice items divided into 7 item subscales for anxiety (HADS-A) and depression (HADS-D). Scores in each subscale range from 0 to 21. Higher scores indicate greater levels of anxiety and/or depression. Clinically significant anxiety or depression are interpreted by scores ≥8.

    It will be evaluated in people with COPD or ILD and informal caregivers.


  8. Disease impact: COPD Assessment Test (CAT) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    CAT is a 8-item questionnaire which addresses cough, sputum, chest tightness, dyspnoea, home daily activities, confidence leaving home, sleep and energy levels in a 6-point scale rated from 0 to 5. Score ranges from 0 to 40. Higher scores indicate more severe impairment on health status. A score of more than 20 indicates high impact.

    It will be evaluated in people with COPD or ILD.


  9. Health-related quality of life: Saint George's Respiratory Questionnaire (SGRQ) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    SGRQ is a 50-item questionnaire which evaluates three different domains contributing to overall health, daily life, and perceived well-being: symptoms, activity and impact. A score in each domain and a total score are calculated and weighted, ranging from 0 to 100. Higher scores indicate worse HRQoL.

    It will be evaluated in people with COPD or ILD.


  10. Needs: Support Needs Approach for Patients (SNAP) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    SNAP includes 15 questions with the format: "Do you need more support with…" (e.g., "Do you need more support with managing your symptoms?"). For each statement, "No", "A little more" and "Quite a bit more" options are provided to identify the domains in need of support. There is an optional additional open-ended question to capture "anything else" not already covered. The final question refers to the caregiver needs: "Does a family member or friend who helps you need more support?".

    It will be evaluated in people with COPD or ILD.


  11. Needs: Carer Support Needs Assessment Tool (CSNAT) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    CSNAT includes 14 questions covering caregivers' broad support domains which fall into two distinct groups: support that enable them to provide care and more direct personal support for themselves. All questions follow the format: "Do you need more support with…" (e.g., "Do you need more support with knowing what to expect in the future?"). For each question, "No", "A little more", "Quite a bit more" and "Very much more" options are provided to identify support needed within any of the domains. There is an optional additional open-ended question to capture "anything else" not already covered.

    It will be evaluated in informal caregivers.


  12. Functional performance: London Chest Activities of Daily Living (LCADL) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    LCADL includes 15 activities of daily living organized in four domains: self-care, domestic, physical and leisure. Each item is rated from 0 ("I wouldn't do it anyway") to 5 ("I need someone else to do this"), except for one additional question on global impact with "A lot", "A little" and "Not at all" as answer choices. Final score ranges from 0 to 75. Higher scores indicate greater functional limitation.

    It will be evaluated in people with COPD or ILD.


  13. Functional capacity: 6-minute walking test (6-MWT) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    6-MWT evaluates de distance walked at a fast pace during 6 minutes in a 30 meters corridor.

    It will be evaluated in people with COPD or ILD.


  14. Peripheral muscle strength: quadriceps strength, one-repetition maximum (1-RM) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    Quadriceps strength, 1-RM: determines the greatest amount of weight that the participant could move in a double leg extension manoeuvre (isotonic strength).

    Measurement is taken on dominant side in kilogram (Kg). It will be evaluated in people with COPD or ILD.


  15. Peripheral muscle strength: handgrip strength, hand-held dynamometer (HHD) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    Handgrip strength, HHD: measures the maximum isometric strength of the hand and forearm muscles.

    Measurement is taken on dominant side in kilogram (Kg). It will be evaluated in people with COPD or ILD.


  16. Balance: Brief-Balance Evaluation Systems Test (Brief-BESTest) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    Brief-BESTest is 8-item scale evaluating 6 domains contributing to postural control in standing and walking: biomechanical constraints, stability limits/verticality, transitions/anticipatory postural adjustments, reactive postural control, sensory orientation and stability gait. Each domain is evaluated with a test scored from 0 (severe impairment) to 3 (no impairment), with a maximum of 24. Higher scores indicate better balance performance.

    It will be evaluated in people with COPD or ILD.


  17. Knowledge about COPD: Bristol COPD Knowledge Questionnaire (BCKQ) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    BCKQ includes 65 statements divided in 13 topics, each with a stem; these topics cover epidemiology and physiology, aetiology, common symptoms, breathlessness, phlegm, chest infections, exercise, smoking, immunization, inhaled bronchodilators, antibiotics, and oral/inhaled steroids. For each statement, "True", "False" and "I don't know" options are provided, and a mark is given for each correct answer. Total score corresponds to the percentage of correct answers.

    It will be evaluated in people with COPD and informal caregivers.


  18. Burden of providing care: Zarit Burden Interview (ZBI) [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]

    ZBI is a 22-item questionnaire addressing impact of caring experience in several domains: health and wellbeing, personal and social life, and finances. Each question has five response options rated from 0 ("Never") to 4 ("Almost always"), except for the final question on global burden, rated from 0 ("Not at all") to 4 ("Extremely"). Final score ranges from 0 to 88. Higher scores indicate greater burden. A score of more than 24 indicates high burden.

    It will be evaluated in informal caregivers.


  19. Adherence to exercise and education/psychosocial support sessions [ Time Frame: Assessment at 12-weeks. ]
    Adherence to exercise sessions will be evaluated in people with COPD or ILD. Adherence to education and psychosocial support sessions will be evaluated in people with COPD or ILD and informal caregivers.

  20. Occurrence of adverse events [ Time Frame: Assessment at 12-weeks. ]
    Occurrence of adverse events will be evaluated in people with COPD or ILD.

  21. Referral to a specialist palliative care team [ Time Frame: Assessment at baseline, at 12-weeks and at 6 months after PR. ]
    Medical decision to refer a person with COPD or ILD to a specialist palliative care team.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

People with COPD or ILD

Inclusion Criteria:

  • diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria or multidisciplinary diagnosis of ILD
  • clinically stable in the previous month (i.e., without acute exacerbation)

Exclusion Criteria:

  • presense of a musculoskeletal, neurological or psychiatric condition which may limit their participation in PR
  • participation in any PR program in the last 6 months
  • specialist palliative care in the last 12 months
  • inability to understand Portuguese

Informal caregivers

Inclusion Criteria:

  • adults identified by the participating people with COPD or ILD as informal caregivers; for this purpose, it will be explained to people with COPD or ILD that an informal caregiver is any relative, partner, friend, neighbor, or significant other with personal relationship with them, and who provides a broad range of unpaid assistance, namely with activities of daily living (e.g., toileting, feeding and bathing) and instrumental activities of daily living (e.g., shopping, meal preparation and managing finances)

Exclusion Criteria:

  • presense of a neurological or psychiatric condition which may limit their participation
  • inability to understand Portuguese

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046547


Contacts
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Contact: Alda S Marques, PhD (+351) 234 372 462 amarques@ua.pt
Contact: Odete M Alves, MSc (+351) 234 372 476 odete.alves@ua.pt

Locations
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Portugal
University of Aveiro Recruiting
Aveiro, Portugal, 3810-193
Contact: Alda S Marques, PhD    (+351) 234 372 462    amarques@ua.pt   
Principal Investigator: Alda S Marques, PhD         
Sponsors and Collaborators
Aveiro University
Centro Hospitalar do Baixo Vouga
Investigators
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Principal Investigator: Alda S Marques, PhD Aveiro University
Publications:

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Responsible Party: Alda Sofia Pires de Dias Marques, Associate Professor, Aveiro University
ClinicalTrials.gov Identifier: NCT06046547    
Other Study ID Numbers: PaC/2023
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: January 30, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alda Sofia Pires de Dias Marques, Aveiro University:
Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Pulmonary Rehabilitation
Palliative Care
Education
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Respiratory Tract Diseases
Chronic Disease
Disease Attributes
Pathologic Processes