TAKINGCARE - TAcKlING the Needs of Loved Ones of People With Chronic respirAtoRy disEases
NCT Number: NCT06459011
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Respiratory Disease
Sponsor: Aveiro University
Collaborators: Fundação para a Ciência e a Tecnologia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-24
Completion Date: 2028-07-31
Locations: University of Aveiro, Aveiro, 3810-193, Portugal

Summary:
This study aims to: i) develop an instrument that assesses the needs of informal carers of people with chronic respiratory diseases (CRD), along diseases' trajectory, and evaluate its measurement properties; ii) identify existing instruments that assess the needs of informal/family carers and their measurement properties, iii) characterize the needs of informal carers of people with CRD and iv) characterize the health literacy of informal carers of people with CRD.

The first task will be a systematic review. For the second and third tasks, people with CRD, their informal carers and health professionals will be recruited via the pulmonology services from the hospitals:Unidade Local de Saúde de Gaia/Espinho, Unidade Local de Saúde da Região de Aveiro, and Unidade Local de Saúde de Entre o Douro e Vouga. On task 2, a mixed-methods study will be conducted to characterize the needs of informal carers of people with CRD, as well as their health literacy. On task 3, an instrument that assesses the needs of informal carers of people with CRD will be developed and its measurement properties will be studied.

This study is urgently needed to provide meaningful support to this hidden workforce who provides most of the care to people with DRC contributing to guide meaningful supportive care to this population and their loved ones.

Primary Outcome Measures: Preparedness for Caregiving Scale (PCS), The PCS was developed to assess the competence/level of preparation of informal/family carers (family member or friend) of elderly people with moderate to severe cognitive or physical decline at home.The scale has 8 items, scored on a 5-point scale (from 0 - "not at all prepared" to 4 - "very well prepared"). The total score varies from 0 to 32, with a higher score corresponding to a better perception of level of preparation It has shown good measurement properties. It will be translated and culturally adapted and applied to informal carers of people with CRD., Task 2 and 3 (baseline)
Secondary Outcome Measures: Six Minute Walk Test (6MWT), The 6MWT is the gold standard exercise test and is commonly used to assess functional status.It is a valid and reliable measure in CRD. It will be used to characterize participants with CRD., Task 2 and 3 (baseline)|: Chronic Airways Assessment Test (CAAT), CAAT is a change to the COPD Assessment Test (CAT) so that it can be applied to people with COPD and/or asthma.It assesses diseases' impact, presenting 8 items related to respiratory symptoms (cough, chest symptoms and impacts on well-being and day-to-day, related to dyspnea, activity limitation, confidence to leave home, sleep and energy level), classified from 0 to 5. The total score is calculated by adding the score of the 8 items, ranging from 0 to 40 points, with a higher score corresponding to a greater impact of the disease. The total score can be divided into 4 levels: 1) low, 2) moderate, 3) high and 4) very high impact. The CAAT proved to be valid and reliable for people with COPD and/or asthma. Similarly, the CAT is a valid and reliable instrument, capable of discriminating people with different degrees of severity of COPD and has been used in different CRD. It will be used to characterize participants with CRD., Task 2 and 3 (baseline)|King's Brief Interstitial Lung Disease (KBILD), The KBILD was the first questionnaire developed to evaluate health related quality of life (HRQoL) in adults with insterstitial lung disease (ILD). It is easy to administer/ (5 to 7 minutes), economic and with excellent measurement properties. It consists of 15 items with a Likert scale of 7 points \[1 - always 7 - never (items 1, 2, 3, 4, 6, 14); 1 - never 7 - always (item 5); 1 - significantly 7 - not at all (item 15)\]. The total score and/or the score by domain (psychological, dyspnoea and activities, and chest symtpoms) can be calculated. The scores are transformed logarithmically, ranging from 0 to 100, and a higher score corresponds to a better perception of HRQoL. It will be used to characterize participants with ILD., Task 2 and 3 (baseline)|5-level EuroQoL-5D (EQ-5D-5L), The EQ-5D-5L was developed by the EuroQol group to assess the perception of a person's current health status. It includes 5 dimensions (mobility, personal care, usual activities, pain, anxiety/depression) with 5 response levels (no problems, mild, moderate, severe or extreme problems). It also includes a vertical visual analogue scale (EQ VAS), which quantifies the perception of health status, ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). Its score can be transformed into Quality Adjusted Life Years and used for cost-utility analyses. The EQ-5D-5L is a simple to use, valid, reliable and responsive measure. It will be applied to people with CRD and their informal carers., Task 2 and 3 (baseline)|Hospital Anxiety and Depression Scale (HADS), The HADS was developed with the aim of providing health professionals with a reliable, valid and easy-to-use measure to identify and quantify the level of depression and anxiety.It consists of two subscales, which are scored separately: one for anxiety (seven items) and one for depression (seven items). Each item is scored from 0 to 3 points, so each subscale varies between 0 and 21 points. A score between 0 and 7 is 'normal', between 8 and 10 shows "light" level, between 11 and 14 "moderate" level, and between 15 and 21 "severe" level of anxiety/depression. It will be applied to people with CRD and their informal carers., Task 2 and 3 (baseline)|Satisfaction with life scale (SWLS), The SWLS was developed to measure overall satisfaction with life as a cognitive component of well-being. The scale presents 5 items, scored from 1 (totally disagrees) to 7 (totally agrees), and the score varies from 5 to 35, with a higher score corresponding to a greater satisfaction with life. It is a widely used instrument and is valid, reliable and can be used in different age groups. It will be applied to people with CRD and their informal carers., Task 2 and 3 (baseline)|Lubben Social Network Scale - 6 items (LSNS-6), The LSNS-6 is a reduced version of the Lubben Scale of Social Networks, which was developed for the assessment of social networks in the elderly population. The score varies from 0 to 30, and a higher score corresponds to a greater social network. A score of less than 12 corresponds to social isolation. It is used internationally and is valid and reliable. It will be applied to people with CRD and their informal carers., Task 2 and 3 (baseline)|World Health Organization Disability Assessment Schedule (WHODAS 2.0), The WHODAS 2.0 was developed by the World Health Organization as a general measure of functionality and disability, is based on the concepts of the International Classification of Functioning, Disability and Health. It captures the level of functionality in 6 domains: cognition, mobility, self-care, interaction with others, day-to-day activities, and participation in society.(from 0 - no difficulty to 4 - extreme difficulty or can not do). A higher score corresponds to a worse level of functionality. It is a simple and easy to apply (5 minutes) measure, being valid and reliable. It will be applied to people with CRD and their informal carers., Task 2 and 3 (baseline)|Zarit Burden Interview (ZBI-22), The ZBI-22 is used to assess the perception of informal carers regarding the impact of the disease on their lives, health and well-being, and social and financial life. It is composed of 22 assertions, scored from 0 (never) to 4 (almost always). The total score ranges from 0 to 88 and a higher score indicates greater burden. It is used worlwide in different contexts. It will be applied to informal carers of people with CRD., Task 2 and 3 (baseline)|Positive Aspects of Caregiving (PAC), The PAC scale reflects the positive aspects of caring for someone, as an informal/family carer,being an adaptation of the Caregiver Satisfaction Scale. It includes 11 items, scored from 1 (disagree a lot) to 5 (agree a lot). The score varies from 11 to 55, and a higher score corresponds to a better perception of the experience as an informal/family carer. It has been used in different contexts and has good measurement properties. It will be applied to informal carers of people with CRD., Task 2 and 3 (baseline)|European Health Literacy Survey - 47 items (HLS-EU-Q47), The HLS-EU-Q47 was developed to assess health literacy considering the current definition of this concept. It consists of 47 items, integrating 3 domains (health care, health promotion and disease prevention) and 4 levels of information processing (access, understanding, evaluation and use). The analysis of health literacy is performed in 12 sub-indexes, which are scored on a 4-point scale (very difficult, difficult, easy, very easy). A higher score corresponds to better health literacy. It will be applied to informal carers of people with CRD., Task 2 and 3 (baseline)|Carer Support Needs Assessment Tool (CSNAT), The CNSAT was developed to assess the needs of informal carers of people with cancer in the terminal phase. This measure has 5 phases: 1. introduction of the instrument; 2. completion of the instrument in its 15 domains; 3. an interview/guided conversation between the carer and the health professional, in which the needs of the carer are identified and prioritized; 4. adaptation solutions to the priorities; 5. review of the results. The process is then repeated at an agreed moment. It is valid and sensitive to change. It will be applied to informal carers of people with CRD and used s content validity to the instrument that will be developed in this project., Task 2 and 3 (baseline)|Qualitative data: interviews, People with CRD and their informal carers, as well as health professionals, may participate in a interview in order to identify, understand and prioritize the needs of informal carers of people with CRD. Data from the interviews will be compared.

For the development of the new instrument, individual cognitive interviews will be conducted with informal carers of people with CRD to refine its final version., Task 2 and 3 (baseline)|Social connectedness and care-related questions, People with CRD and their informal carers: Geographical proximity to most of the social network; Social participation; Number of people providing informal care; Type of support received/provided; Relationship with the care provider/recipient; How good is the relationship with the care provider/recipient; Do you live with the care provider/recipient; Hours spent receiving/providing informal care per week; Frequency of informal care received/provided per week; Duration of informal care received/provided; Do you provide care to someone;

People with CRD: Formal/informal care; Types of formal care; Hours spent receiving formal care per week; Satisfaction with informal care received

Informal Carers of people with CRD: Recognised informal care status; Number of people providing care for; Impact on job/work due to caring for someone; Impact on sleep due to caring for someone, Task 2 and 3 (baseline)
Other Outcome Measures: Sociodemographic data, People with CRD: Sex; Age; Year of birth; Level of education; Occupation; Type of employment contract; Marital status; Municipality; Area of residence; Home ownership; Type of housing; Physical modifications to the house due to the CRD; Religious affiliation; Race;Socio-economic status (gross monthly income)

Informal carers of people with CRD: Sex; Age; Year of birth; Level of education; Occupation; Type of employment contract; Marital status; Municipality; Area of residence; Home ownership; Type of housing; Religious affiliation; Race;Socio-economic status (gross monthly income)

Health professionals: Sex; Age; Year of birth; Level of education; Specialisation, Task 2 and 3 (baseline)|Clinical data, People with CRD: Cognitive status (6-item cognitive impairment test); Diagnosis; Year of diagnosis; Disease stage; Lung function; Smoking status; Long-term Oxygen Therapy; Non-invasive ventilation; Comorbidities; Medication; Healthcare utilisation in the previous year; Number of exacerbations in previous year; Number of falls; Mobility aids

Informal carerss of people with CRD: Smoking status; Comorbidities; Medication; Healthcare utilisation in the previous year; Number of falls, Task 2 and 3 (baseline)|Anthropometric data, People with CRD and their informal carers: height (meters); weight (Kg); Body mass index (kg/m\^2), Task 2 and 3 (baseline)|Contact with people with CRD, Health professionals: Duration of contact with peple with CRD in clinical practice, Task 2 (baseline)