Chronic respiratory diseases are leading causes of death and disability worldwide, imposing an enormous burden on individuals, families, and societies. Dependence on others begins early in the disease course. Over 70% of people with a chronic respiratory disease rely on informal care for daily assistance. Informal carers face multiple demands that may affect their health and ability to provide care. However, support interventions remain largely absent. Informal carers have identified pulmonary rehabilitation as an opportunity to also support them. Pulmonary rehabilitation is a cornerstone non-pharmacological intervention comprising exercise training, education, psychosocial support, and behaviour change, and is known to improve symptoms, functional capacity, quality of life, and survival. Although including informal carers in pulmonary rehabilitation has shown promising benefits for family adjustment, pulmonary rehabilitation remains patient-centred, with no dedicated support for carers' specific needs.
This study will therefore redesign pulmonary rehabilitation to act as a dual-support intervention for both people with chronic respiratory disease and their informal carers. The study aims to assess the effects of carer inclusive pulmonary rehabilitation on preparedness for caregiving.
A total of 120 patient-informal carer dyads will be randomly assigned to either carer inclusive pulmonary rehabilitation or standard pulmonary rehabilitation. In both groups, patients will undergo pulmonary rehabilitation. In the carer inclusive pulmonary rehabilitation group, informal carers will also participate in the education and psychosocial support sessions, which will be specifically designed to also address their needs. In the standard pulmonary rehabilitation group, informal carers will not participate in the pulmonary rehabilitation programme.
Aged 18 years or older.
Providing unpaid informational, physical, practical, emotional, social, or financial support to a person with a chronic respiratory disease.
Identified by the patient as the primary informal carer
Aged 18 years or older
Unable to provide informed consent
Signs of cognitive impairment
Unable to provide informed consent
Signs of cognitive impairment
Parallel
Carer inclusive pulmonary rehabilitation
BehavioralPeople with chronic respiratory diseases will undergo a 12-week pulmonary rehabilitation programme comprising two supervised exercise training sessions per week and one education and psychosocial support session every fortnight. Informal carers will participate in the education and psychosocial support sessions, which will be specifically designed to address both patients' and informal carers' educational and psychosocial support needs. They will also observe patients' response to exercise at the beginning, middle and end of the pulmonary rehabilitation programme. All sessions will be conducted face-to-face and will last 60-90 minutes. Exercise training sessions will be delivered by an experienced physiotherapist, following international recommendations and previous publications. A dedicated separate space for patients and for informal carers to share their experiences among their peers will be available at beginning, middle and end of the pulmonary rehabilitation programme.
Pulmonary rehabilitation
BehavioralThe intervention of the control group will be the standard care, where people with chronic respiratory diseases will undergo pulmonary rehabilitation for 12 weeks. Pulmonary rehabilitation will comprise two supervised exercise training sessions per week (including endurance, resistance and functional training) and one education and psychosocial support session every fortnight. All sessions will be conducted face-to-face, with each lasting 60-90 minutes. Exercise training sessions will be delivered by an experienced physiotherapist, following international recommendations and previous publications. Informal carers will not participate in the pulmonary rehabilitation programme.
Preparedness for caregiving scale
Assessed in informal carers. The Preparedness for Caregiving Scale is an eight-item self-report questionnaire that measures caregivers' perceived preparedness to provide physical and emotional care, coordinate services, manage stress, respond to emergencies, navigate the healthcare system, and their overall preparedness for caregiving. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated by summing the scores for all eight items, with higher scores indicating greater perceived preparedness for caregiving.
Short-Form Zarit Burden Interview
Assessed in informal carers. The Short-Form Zarit Burden Interview is a 12-item self-report questionnaire that measures carer burden. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated by summing the scores for all 12 items, with higher scores indicating greater burden.
Hospital Anxiety and Depression Scale
Assessed in informal carers and people with chronic respiratory disease. The Hospital Anxiety and Depression Scale has 14 items: 7 measuring symptoms of anxiety (HADS-A) and another 7 measuring symptoms of depression (HADS-D). Score ranges from 0 (minimum symptom overload) to 21 (maximum symptom overload) for the HADS-A and HADS-D.
EQ-5D-5L
Assessed in informal carers and people with chronic respiratory disease. The EQ-5D-5L self-report questionnaire comprised two components: the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The descriptive system measures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions can be combined in a 5-digit code and converted to an index score. Higher scores in the index and EQ-VAS indicate better health-related quality of life.
Lung Information Needs Questionnaire
Assessed in informal carers and people with chronic respiratory disease. The Lung Information Needs Questionnaire is a self-administered questionnaire that assesses information needs. It consists of 16 questions across six domains: disease knowledge, medicines, self-management, smoking, exercise, and diet. Higher scores indicate greater information and education needs.
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Aveiro University
Lead sponsor
Unidade Local de Saúde Matosinhos
Collaborator
Unidade Local de Saúde Gaia/Espinho
Collaborator
Unidade Local de Saúde da Região de Aveiro
Collaborator
Unidade Local de Saúde do Baixo Mondego
Collaborator
Unidade Local de Saúde Santa Maria
Collaborator
Unidade Local de Saude Entre o Douro e Vouga
Collaborator
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