Integrating Palliative Care Education in Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Knowledge about palliative care: Palliative Care Knowledge Scale (PaCKS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Knowledge about palliative care: Palliative Care Knowledge Scale (PaCKS)
时间窗: 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.
次要结局
- Cough: Leicester Cough Questionnaire (LCQ)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Pain: "Do you feel pain?"(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Fatigue: Fatigue Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-FS)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Referral to a specialist palliative care team(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Occurrence of adverse events(Assessment at 12-weeks.)
- Needs: Carer Support Needs Assessment Tool (CSNAT)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Peripheral muscle strength: quadriceps strength, one-repetition maximum (1-RM)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Peripheral muscle strength: handgrip strength, hand-held dynamometer (HHD)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Balance: Brief-Balance Evaluation Systems Test (Brief-BESTest)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Adherence to exercise and education/psychosocial support sessions(Assessment at 12-weeks.)
- 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?"(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Needs: Support Needs Approach for Patients (SNAP)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Functional capacity: 6-minute walking test (6-MWT)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Knowledge about COPD: Bristol COPD Knowledge Questionnaire (BCKQ)(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 at this time?"(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Dyspnoea: modified Medical Research Council questionnaire (mMRC)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Disease impact: COPD Assessment Test (CAT)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Health-related quality of life: Saint George's Respiratory Questionnaire (SGRQ)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Functional performance: London Chest Activities of Daily Living (LCADL)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
- Burden of providing care: Zarit Burden Interview (ZBI)(Assessment at baseline, at 12-weeks and at 6 months after PR.)
研究者
Alda Sofia Pires de Dias Marques
Associate Professor
Aveiro University