TAKINGCARE - TAcKlING the Needs of Carers of People With Chronic respirAtoRy disEases
ConditionChronic Respiratory Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAveiro University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years of age or older;
Diagnosed with ILD, COPD, lung cancer, severe asthma or bronchiectasis;
Fluent in Portuguese;
Identify an informal/family carer;
Disqualifiers
Signs of cognitive impairment in the Six-item Cognitive Impairment Test (6CIT) for the interviews.
Signs of cognitive impairment in the 6CIT.
Trial population
People with chronic respiratory diseases, informal carers of people with chronic respiratory diseases, and health professionals
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Task 2 and 3 (baseline)Secondary outcomes
1
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.
Time frame
Task 2 and 3 (baseline)2
: 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.
Time frame
Task 2 and 3 (baseline)3
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.
Time frame
Task 2 and 3 (baseline)4
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.
Time frame
Task 2 and 3 (baseline)Other outcomes
1
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
Time frame
Task 2 and 3 (baseline)2
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
Time frame
Task 2 and 3 (baseline)3
Anthropometric data
People with CRD and their informal carers: height (meters); weight (Kg); Body mass index (kg/m\^2)
Time frame
Task 2 and 3 (baseline)4
Contact with people with CRD
Health professionals: Duration of contact with peple with CRD in clinical practice
Time frame
Task 2 (baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aveiro University
Lead sponsor
Fundação para a Ciência e a Tecnologia
Collaborator
Source ClinicalTrials.gov