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.
Chronic obstructive pulmonary disease (COPD) and interstitial lung diseases (ILD) have an overwhelming impact on individuals, society and health systems worldwide. Informal caregivers play an essential role in the lives of people with COPD or ILD, however little is known about how to support them. Palliative care addresses multiple unmet needs of people with COPD or ILD and informal caregivers, but it remains highly inaccessible. Pulmonary rehabilitation (PR) is a fundamental evidence-based intervention for the management of COPD and ILD, and may be an opportunity to introduce palliative care. However, the effects of this integrated care model on patients' and informal caregivers' outcomes are still unclear. Therefore, this study proposes to develop, implement and evaluate an innovative PR model with palliative care education. The primary aim is to explore the effects of palliative care education as part of PR on people with COPD or ILD and informal caregivers' knowledge about palliative care. The secondary aims are: a) to understand the perspectives of people with COPD or ILD and informal caregivers about integrating palliative care education in PR; and b) to explore the short and medium-term effects of palliative care education as part of PR on people with COPD or ILD and informal caregivers' attitude towards palliative care referral, symptoms, disease impact, health-related quality of life (HRQoL), needs, knowledge about the disease and burden. Recruitment will occur at the outpatient PR unit at Centro Hospitalar Baixo Vouga (CHBV). The pulmonologist of the PR program will identify eligible participants (i.e., people with COPD or ILD and informal caregivers) and explain the study. An appointment for the baseline assessment will be scheduled with those willing to participate. Participants will be randomised to experimental group (EG) and control group (CG). Both groups will follow a multidisciplinary team-based PR program, which will include two weekly supervised exercise sessions and weekly education and psychosocial support sessions in a group setting over a 12-week period. Informal caregivers will be invited to take part in all education and psychosocial support sessions. The key educational topics explored in the EG group will be: 1) information on chronic respiratory diseases; 2) medication, inhaler techniques, oxygen therapy and non-invasive ventilation; 3) symptom management and exacerbations; 4) palliative care; 5) exercise and physical activity; 6) action plan; 7) anxiety and depression management; and 8) nutrition. Additionally, there will be two sessions: "Peer-to-peer session" and "Get-apart session". In both the focus will be to discuss participants' own issues with the multidisciplinary team. Moreover, every two weeks, participants will have the opportunity to discuss any health-related issue through online sessions. Individual cases will also be referred for evaluation by a specialist palliative care team or by any other health and social care professional (e.g., psychologist or social worker) according to the specific unmet needs identified. The EG will receive the PR program as described above and the CG will receive the traditional PR program i.e., without the education session on palliative care, the "Peer-to-peer session", the "Get-apart session" and the online sessions. Quantitative data will be collected from all participants at baseline, at 12 weeks (i.e., end of PR) and at 6 months post-PR. Qualitative data will be collected only from the EG before and after PR. The following quantitative data will be collected from people with COPD or ILD: sociodemographic information; health status (e.g., exacerbation(s) within the last 12 months); health literacy; anthropometry; respiratory function; symptoms (pain, dyspnoea, fatigue, cough, and anxiety and depression) and disease impact; HRQoL; needs; functional performance and capacity; peripheral muscle strength; balance; knowledge about palliative care and the disease; and attitude towards palliative care referral. Informal caregivers will also provide information on: health status (e.g., limitation(s) in activities of daily living); health literacy; role of caring (e.g., relationship with the care receiver); symptoms (pain, fatigue, and anxiety and depression); needs; burden; knowledge about palliative care and the disease; and attitude towards palliative care referral. Qualitative data will be collected through focus groups. Sample size was estimated with the program G\*Power 3.1.9.4, with an effect size specification "as in GPower 3.0", for the within-between interaction of mixed ANOVA with two groups (control and experimental) and two timepoints (pre and post PR). The investigators considered an α of 0.05, a power of 0.80, a correlation among repeated measures of 0.5, a nonsphericity correction of 1 and an expected effect size f of 0.25. The calculated sample size was 34 and considering a possible 40% dropout and missing data rate, the final sample size was determined to be 58.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
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.
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).
University of Aveiro
Aveiro, Portugal
RECRUITINGKnowledge 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.
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.
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.
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.
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.
Fatigue: Fatigue Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-FS)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Cough: Leicester Cough Questionnaire (LCQ)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Disease impact: COPD Assessment Test (CAT)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Health-related quality of life: Saint George's Respiratory Questionnaire (SGRQ)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Needs: Support Needs Approach for Patients (SNAP)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Needs: Carer Support Needs Assessment Tool (CSNAT)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Functional performance: London Chest Activities of Daily Living (LCADL)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Functional capacity: 6-minute walking test (6-MWT)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Peripheral muscle strength: quadriceps strength, one-repetition maximum (1-RM)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Peripheral muscle strength: handgrip strength, hand-held dynamometer (HHD)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Balance: Brief-Balance Evaluation Systems Test (Brief-BESTest)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Knowledge about COPD: Bristol COPD Knowledge Questionnaire (BCKQ)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Burden of providing care: Zarit Burden Interview (ZBI)
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.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Adherence to exercise and education/psychosocial support sessions
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.
Time frame: Assessment at 12-weeks.
Occurrence of adverse events
Occurrence of adverse events will be evaluated in people with COPD or ILD.
Time frame: Assessment at 12-weeks.
Referral to a specialist palliative care team
Medical decision to refer a person with COPD or ILD to a specialist palliative care team.
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
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