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.