Clinical trial NCT06046547: Integrating Palliative Care Education in Pulmonary Rehabilitation
Official title: Integrating Palliative Care Education in Pulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Keywords: Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Pulmonary Rehabilitation
Palliative Care
Education
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar do Baixo Vouga
First posted: 2023-09-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Knowledge about palliative care: Palliative Care Knowledge Scale (PaCKS)
timeFrame: Assessment at baseline, at 12-weeks (i.e., end of PR) and at 6 months after PR.
Secondary outcomes:
measure: Attitude towards palliative care referral: "Would you (your loved one) like to be referred to a specialist palliative care team at this time?"
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: 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?"
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Pain: "Do you feel pain?"
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Dyspnoea: modified Medical Research Council questionnaire (mMRC)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Fatigue: Fatigue Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-FS)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Cough: Leicester Cough Questionnaire (LCQ)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Disease impact: COPD Assessment Test (CAT)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Health-related quality of life: Saint George's Respiratory Questionnaire (SGRQ)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Needs: Support Needs Approach for Patients (SNAP)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Needs: Carer Support Needs Assessment Tool (CSNAT)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Functional performance: London Chest Activities of Daily Living (LCADL)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Functional capacity: 6-minute walking test (6-MWT)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Peripheral muscle strength: quadriceps strength, one-repetition maximum (1-RM)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Peripheral muscle strength: handgrip strength, hand-held dynamometer (HHD)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Balance: Brief-Balance Evaluation Systems Test (Brief-BESTest)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Knowledge about COPD: Bristol COPD Knowledge Questionnaire (BCKQ)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Burden of providing care: Zarit Burden Interview (ZBI)
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
measure: Adherence to exercise and education/psychosocial support sessions
timeFrame: Assessment at 12-weeks.
measure: Occurrence of adverse events
timeFrame: Assessment at 12-weeks.
measure: Referral to a specialist palliative care team
timeFrame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: University of Aveiro
Study officials:
affiliation: Aveiro University
name: Alda S Marques, PhD
role: PRINCIPAL_INVESTIGATOR
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