Integrating Palliative Care Education in Pulmonary Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAveiro University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary rehabilitation integrating education about palliative care
Other interventionPR 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
Other interventionParticipants 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).
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Pulmonary rehabilitation with palliative care educationExperimental treatment 1 intervention
Group B: Pulmonary rehabilitationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Assessment at baseline, at 12-weeks (i.e., end of PR) and at 6 months after PR.Secondary outcomes
1
Attitude towards palliative care referral: "Would you (your loved one) like to be referred to a specialist palliative care team at this time?"
Possible answers: "Yes", "No" and "I don't know". It will be evaluated in people with COPD or ILD and informal caregivers.
Time frame
Assessment at baseline, at 12-weeks and at 6 months after PR.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?"
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.
Time frame
Assessment at baseline, at 12-weeks and at 6 months after PR.3
Pain: "Do you feel pain?"
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.
Time frame
Assessment at baseline, at 12-weeks and at 6 months after PR.4
Dyspnoea: modified Medical Research Council questionnaire (mMRC)
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.
Time frame
Assessment at baseline, at 12-weeks and at 6 months after PR.Sponsors and contacts
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Aveiro University
Lead sponsor
Centro Hospitalar do Baixo Vouga
Collaborator
Source ClinicalTrials.gov