Chronic Obstructive Pulmonary DiseaseNCT06046547
Integrating Palliative Care Education in Pulmonary Rehabilitation
A study testing Pulmonary rehabilitation integrating education about palliative care and Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by Aveiro University at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- What is being tested?
- Pulmonary rehabilitation integrating education about palliative care and Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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)
Who cannot join
- 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
- presense of a neurological or psychiatric condition which may limit their participation
- inability to understand Portuguese
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
University of Aveiro
Aveiro, 3810-193
Alda S Marques, PhD, (+351) 234 372 462, amarques@ua.pt
Alda S Marques, PhD
About this study
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?".
Read more
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.
Read the 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.
- Being tested
- Pulmonary rehabilitation integrating education about palliative care, Pulmonary rehabilitation
- Keywords
- Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Pulmonary Rehabilitation, Palliative Care, Education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation integrating education about palliative careOther
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 rehabilitationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation with palliative care education | Experimental | The experimental group will participate in PR with palliative care education. Receives: Other: Pulmonary rehabilitation integrating education about palliative care |
| Pulmonary rehabilitation | Active comparator | The control group will participate in traditional PR. Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?"
Possible answers: "Yes", "No" and "I don't know". It will be evaluated in people with COPD or ILD and informal caregivers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessment at 12-weeks.
Occurrence of adverse events
Occurrence of adverse events will be evaluated in people with COPD or ILD.
Measured: 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.
Measured: Assessment at baseline, at 12-weeks and at 6 months after PR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar do Baixo Vouga
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda S Marques, PhD, Principal investigator, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046547
- Sponsor's protocol ID
- PaC/2023
- Status last verified
- Jan 2024
- First submitted
- 1 Sep 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marx G, Nasse M, Stanze H, Boakye SO, Nauck F, Schneider N. Meaning of living with severe chronic obstructive lung disease: a qualitative study. BMJ Open. 2016 Dec 8;6(12):e011555. doi: 10.1136/bmjopen-2016-011555.
PubMed 27932338Maddocks M, Lovell N, Booth S, Man WD, Higginson IJ. Palliative care and management of troublesome symptoms for people with chronic obstructive pulmonary disease. Lancet. 2017 Sep 2;390(10098):988-1002. doi: 10.1016/S0140-6736(17)32127-X.
PubMed 28872031Sigurgeirsdottir J, Halldorsdottir S, Arnardottir RH, Gudmundsson G, Bjornsson EH. COPD patients' experiences, self-reported needs, and needs-driven strategies to cope with self-management. Int J Chron Obstruct Pulmon Dis. 2019 May 16;14:1033-1043. doi: 10.2147/COPD.S201068. eCollection 2019.
PubMed 31190788Bryant J, Mansfield E, Boyes AW, Waller A, Sanson-Fisher R, Regan T. Involvement of informal caregivers in supporting patients with COPD: a review of intervention studies. Int J Chron Obstruct Pulmon Dis. 2016 Jul 14;11:1587-96. doi: 10.2147/COPD.S107571. eCollection 2016.
PubMed 27478372Nakken N, Janssen DJ, van den Bogaart EH, Wouters EF, Franssen FM, Vercoulen JH, Spruit MA. Informal caregivers of patients with COPD: Home Sweet Home? Eur Respir Rev. 2015 Sep;24(137):498-504. doi: 10.1183/16000617.00010114.
PubMed 26324811Miravitlles M, Pena-Longobardo LM, Oliva-Moreno J, Hidalgo-Vega A. Caregivers' burden in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015 Feb 12;10:347-56. doi: 10.2147/COPD.S76091. eCollection 2015.
PubMed 25709429Figueiredo D, Gabriel R, Jacome C, Cruz J, Marques A. Caring for relatives with chronic obstructive pulmonary disease: how does the disease severity impact on family carers? Aging Ment Health. 2014;18(3):385-93. doi: 10.1080/13607863.2013.837146. Epub 2013 Sep 20.
PubMed 24053489Cruz J, Marques A, Figueiredo D. Impacts of COPD on family carers and supportive interventions: a narrative review. Health Soc Care Community. 2017 Jan;25(1):11-25. doi: 10.1111/hsc.12292. Epub 2015 Oct 26.
PubMed 26499310Giacomini M, DeJean D, Simeonov D, Smith A. Experiences of living and dying with COPD: a systematic review and synthesis of the qualitative empirical literature. Ont Health Technol Assess Ser. 2012;12(13):1-47. Epub 2012 Mar 1.
PubMed 23074423Figueiredo D, Cruz J, Jacome C, Marques A. Exploring the Benefits to Caregivers of a Family-Oriented Pulmonary Rehabilitation Program. Respir Care. 2016 Aug;61(8):1081-9. doi: 10.4187/respcare.04624. Epub 2016 Jul 5.
PubMed 27381202Marques A, Jacome C, Cruz J, Gabriel R, Brooks D, Figueiredo D. Family-based psychosocial support and education as part of pulmonary rehabilitation in COPD: a randomized controlled trial. Chest. 2015 Mar;147(3):662-672. doi: 10.1378/chest.14-1488.
PubMed 25340477Grosbois JM, Gephine S, Kyheng M, Le Rouzic O, Chenivesse C. Improving the wellbeing of caregivers of patients with COPD using a home-based pulmonary rehabilitation programme. ERJ Open Res. 2022 Dec 12;8(4):00255-2022. doi: 10.1183/23120541.00255-2022. eCollection 2022 Oct.
PubMed 36655219Marques 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.
PubMed 25255297Marques A, Cruz J, Brooks D. Interventions to Support Informal Caregivers of People with Chronic Obstructive Pulmonary Disease: A Systematic Literature Review. Respiration. 2021;100(12):1230-1242. doi: 10.1159/000517032. Epub 2021 Jul 14.
PubMed 34261069Holland AE, Cox NS, Houchen-Wolloff L, Rochester CL, Garvey C, ZuWallack R, Nici L, Limberg T, Lareau SC, Yawn BP, Galwicki M, Troosters T, Steiner M, Casaburi R, Clini E, Goldstein RS, Singh SJ. Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2021 May;18(5):e12-e29. doi: 10.1513/AnnalsATS.202102-146ST.
PubMed 33929307
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Palliative Care Education in Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT06046547
- Acronym / sponsor ID
- PaC/2023
- Keywords
- Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Pulmonary Rehabilitation, Palliative Care, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Centro Hospitalar do Baixo Vouga
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation with palliative care education | Experimental | Other: Pulmonary rehabilitation integrating education about palliative careThe experimental group will participate in PR with palliative care education. |
| Pulmonary rehabilitation | Active comparator | Other: Pulmonary rehabilitationThe control group will participate in traditional PR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation integrating education about palliative carePR 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. | Other | Pulmonary rehabilitation with palliative care education |
| Pulmonary rehabilitationParticipants 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). | Other | Pulmonary rehabilitation |
Primary outcome
Knowledge about palliative care: Palliative Care Knowledge Scale (PaCKS)
Time frame: Assessment at baseline, at 12-weeks (i.e., end of PR) and at 6 months after PR.
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.
21 secondary outcomes
Attitude towards palliative care referral: "Would you (your loved one) like to be referred to a specialist palliative care team at this time?"
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?"
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Pain: "Do you feel pain?"
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Dyspnoea: modified Medical Research Council questionnaire (mMRC)
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)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Cough: Leicester Cough Questionnaire (LCQ)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Disease impact: COPD Assessment Test (CAT)
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)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Needs: Support Needs Approach for Patients (SNAP)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Needs: Carer Support Needs Assessment Tool (CSNAT)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Functional performance: London Chest Activities of Daily Living (LCADL)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Functional capacity: 6-minute walking test (6-MWT)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Peripheral muscle strength: quadriceps strength, one-repetition maximum (1-RM)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Peripheral muscle strength: handgrip strength, hand-held dynamometer (HHD)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Balance: Brief-Balance Evaluation Systems Test (Brief-BESTest)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Knowledge about COPD: Bristol COPD Knowledge Questionnaire (BCKQ)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Burden of providing care: Zarit Burden Interview (ZBI)
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Adherence to exercise and education/psychosocial support sessions
Time frame: Assessment at 12-weeks.
Occurrence of adverse events
Time frame: Assessment at 12-weeks.
Referral to a specialist palliative care team
Time frame: Assessment at baseline, at 12-weeks and at 6 months after PR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 27932338Marx G, Nasse M, Stanze H, Boakye SO, Nauck F, Schneider N. Meaning of living with severe chronic obstructive lung disease: a qualitative study. BMJ Open. 2016 Dec 8;6(12):e011555. doi: 10.1136/bmjopen-2016-011555.
- Background: PubMed 28872031Maddocks M, Lovell N, Booth S, Man WD, Higginson IJ. Palliative care and management of troublesome symptoms for people with chronic obstructive pulmonary disease. Lancet. 2017 Sep 2;390(10098):988-1002. doi: 10.1016/S0140-6736(17)32127-X.
- Background: PubMed 31190788Sigurgeirsdottir J, Halldorsdottir S, Arnardottir RH, Gudmundsson G, Bjornsson EH. COPD patients' experiences, self-reported needs, and needs-driven strategies to cope with self-management. Int J Chron Obstruct Pulmon Dis. 2019 May 16;14:1033-1043. doi: 10.2147/COPD.S201068. eCollection 2019.
- Background: PubMed 27478372Bryant J, Mansfield E, Boyes AW, Waller A, Sanson-Fisher R, Regan T. Involvement of informal caregivers in supporting patients with COPD: a review of intervention studies. Int J Chron Obstruct Pulmon Dis. 2016 Jul 14;11:1587-96. doi: 10.2147/COPD.S107571. eCollection 2016.
- Background: PubMed 26324811Nakken N, Janssen DJ, van den Bogaart EH, Wouters EF, Franssen FM, Vercoulen JH, Spruit MA. Informal caregivers of patients with COPD: Home Sweet Home? Eur Respir Rev. 2015 Sep;24(137):498-504. doi: 10.1183/16000617.00010114.
- Background: PubMed 25709429Miravitlles M, Pena-Longobardo LM, Oliva-Moreno J, Hidalgo-Vega A. Caregivers' burden in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015 Feb 12;10:347-56. doi: 10.2147/COPD.S76091. eCollection 2015.
- Background: PubMed 24053489Figueiredo D, Gabriel R, Jacome C, Cruz J, Marques A. Caring for relatives with chronic obstructive pulmonary disease: how does the disease severity impact on family carers? Aging Ment Health. 2014;18(3):385-93. doi: 10.1080/13607863.2013.837146. Epub 2013 Sep 20.
- Background: PubMed 26499310Cruz J, Marques A, Figueiredo D. Impacts of COPD on family carers and supportive interventions: a narrative review. Health Soc Care Community. 2017 Jan;25(1):11-25. doi: 10.1111/hsc.12292. Epub 2015 Oct 26.
- Background: PubMed 23074423Giacomini M, DeJean D, Simeonov D, Smith A. Experiences of living and dying with COPD: a systematic review and synthesis of the qualitative empirical literature. Ont Health Technol Assess Ser. 2012;12(13):1-47. Epub 2012 Mar 1.
- Background: PubMed 27381202Figueiredo D, Cruz J, Jacome C, Marques A. Exploring the Benefits to Caregivers of a Family-Oriented Pulmonary Rehabilitation Program. Respir Care. 2016 Aug;61(8):1081-9. doi: 10.4187/respcare.04624. Epub 2016 Jul 5.
- Background: PubMed 25340477Marques A, Jacome C, Cruz J, Gabriel R, Brooks D, Figueiredo D. Family-based psychosocial support and education as part of pulmonary rehabilitation in COPD: a randomized controlled trial. Chest. 2015 Mar;147(3):662-672. doi: 10.1378/chest.14-1488.
- Background: PubMed 36655219Grosbois JM, Gephine S, Kyheng M, Le Rouzic O, Chenivesse C. Improving the wellbeing of caregivers of patients with COPD using a home-based pulmonary rehabilitation programme. ERJ Open Res. 2022 Dec 12;8(4):00255-2022. doi: 10.1183/23120541.00255-2022. eCollection 2022 Oct.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alda S Marques, PhD principal investigator
Aveiro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation integrating education about palliative care and Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alda S Marques, PhD ((+351) 234 372 462, amarques@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about palliative care: Palliative Care Knowledge Scale (PaCKS) (time frame: Assessment at baseline, at 12-weeks (i.e., end of PR) and at 6 months after PR.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06046547, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.