Integrating Palliative Care Education in Pulmonary Rehabilitation

NCT06046547 | Recruiting

• 1 other identifier: PaC/2023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease

Keywords

Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease; Pulmonary Rehabilitation; Palliative Care; Education

Outcome Measures

Primary Outcomes (1)

• Knowledge about palliative care: Palliative Care Knowledge Scale (PaCKS)

  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.

  Assessment at baseline, at 12-weeks (i.e., end of PR) and at 6 months after PR.

Secondary Outcomes (21)

• Attitude towards palliative care referral: "Would you (your loved one) like to be referred to a specialist palliative care team at this time?"

  Assessment at baseline, at 12-weeks and at 6 months after PR.

• 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?"

  Assessment at baseline, at 12-weeks and at 6 months after PR.

• Pain: "Do you feel pain?"

  Assessment at baseline, at 12-weeks and at 6 months after PR.

• Dyspnoea: modified Medical Research Council questionnaire (mMRC)

  Assessment at baseline, at 12-weeks and at 6 months after PR.

• Fatigue: Fatigue Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-FS)

  Assessment at baseline, at 12-weeks and at 6 months after PR.

Study Arms (2)

Pulmonary rehabilitation with palliative care education

EXPERIMENTAL

The experimental group will participate in PR with palliative care education.

Other: Pulmonary rehabilitation integrating education about palliative care

Pulmonary rehabilitation

ACTIVE COMPARATOR

The control group will participate in traditional PR.

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation integrating education about palliative care OTHER

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.

Pulmonary rehabilitation with palliative care education

Pulmonary rehabilitation OTHER

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).

Pulmonary rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Aveiro University: lead
• Centro Hospitalar do Baixo Vouga: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

RECRUITING

Related Publications (25)

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• Marques A, Gabriel R, Jacome C, Cruz J, Brooks D, Figueiredo D. Development of a family-based pulmonary rehabilitation programme: an exploratory study. Disabil Rehabil. 2015;37(15):1340-6. doi: 10.3109/09638288.2014.964376. Epub 2014 Sep 25.

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• Mendes MA, Janssen DJA, Marques A. Integrating palliative care education in pulmonary rehabilitation: a randomized controlled study protocol. BMC Palliat Care. 2024 Mar 20;23(1):76. doi: 10.1186/s12904-024-01363-0.

  PMID: 38504215 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alda S Marques, PhD

  Aveiro University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alda S Marques, PhD

CONTACT

(+351) 234 372 462; amarques@ua.pt

Odete M Alves, MSc

CONTACT

(+351) 234 372 476; odete.alves@ua.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

PT (1)