TAKINGCARE - TAcKlING the Needs of Carers of People With Chronic respirAtoRy disEases

Last updated: December 12, 2024
Sponsor: Aveiro University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Bronchitis

Treatment

N/A

Clinical Study ID

NCT06459011
PRT/BD/154726/2023
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • People with chronic respiratory diseases (CRD):

  • 18 years of age or older;

  • Diagnosed with ILD, COPD, lung cancer, severe asthma or bronchiectasis;

  • Fluent in Portuguese;

  • Identify an informal/family carer;

  • Informal carers of people with CRD:

  • 18 years of age or older;

  • Fluent in Portuguese.

  • Health Professionals:

  • Fluent in Portuguese;

  • Contact with people with CRD in their clinical practice.

Exclusion

Exclusion Criteria:

  • People with CRD:

  • Signs of cognitive impairment in the Six-item Cognitive Impairment Test (6CIT)for the interviews.

  • Informal carers of people with CRD:

  • Signs of cognitive impairment in the 6CIT.

Study Design

Total Participants: 250
Study Start date:
June 24, 2024
Estimated Completion Date:
July 31, 2028

Study Description

Chronic respiratory diseases (CRD) are the 3rd leading cause of death and disability worldwide, with high burden for individuals, but also for their families and society, including health services. They are systemic, with pulmonary and extrapulmonary manisfestations, and are characterized by a progressive decline on multiple activities of daily living making this people depend on others along diseases' trajectory.

Daily, informal/family carers, who may be relatives, partners, friends or neighbours, with a significant personal relationship with an elderly person or an adult with a disabling chronic disease, are the main source of support of people with CRD. They have a multiplicity of roles in providing physical, financial, psychological/emotional, social, and spiritual support. It is assumed that informal/family carers have the appropriate level of health literacy, disease knowledge, financial security, household conditions, psychological readiness, and medical care abilities to support the person with CRD.

Although they report positive experiences (e.g., personal growth, satisfaction), there has been an acknowledgement of negative impacts (e.g., burden, difficulty in realizing personal interests/projects) and specific needs related to their roles. Nevertheless, their needs are usually unmet and rarely assessed, and they are highly neglected by the social/health system, as well as in research. Assessment of this needs is the first step to provide meaningful support to this hidden workforce who provides most of the care to people with CRD and it has been emphasised by the European Union's recommendations to support and empower informal carers. However, only two instruments have been explicitly designed to assess their needs: the Carers' Alert Thermometer and the Carer Support Needs Assessment Tool (CSNAT), but their routine use is limited, their measurement properties have been scarcely explored and only for COPD, and studies have focused on end-of-life situations.

Therefore, the primary aim of this study is to develop a new instrument to assess the needs of loved ones across CRD' trajectory. Secondary aims are to map available instruments that assess the needs of informal/family carers and their measurement properties, and characterize the needs of informal carers of people with CRD and their health literacy.

This study will be carried out at the University of Aveiro, at the Laboratory of Research and Respiratory Rehabilitation of the School of Health Sciences of the University of Aveiro, at Unidade Local de Saúde de Gaia/Espinho, at Unidade Local de Saúde da Região de Aveiro, and at Unidade Local de Saúde de Entre o Douro e Vouga, in Portugal.

It comprises three tasks: task 1 will consist of a systematic review, in which the instruments that assess the needs of informal/family carers and their measurement properties will be identified; task 2 will be a cross-sectional study where the needs of informal carers of people with CRD and their health literacy will be characterized, through a mixed-methods study, integrating people with CRD, their informal carers, and health professionals; task 3 will be the development of an instrument that assesses the needs of informal carers of people with CRD. The items will be generated based on tasks 1 and 2 and following existing guidelines. The instrument will be pilot-tested, and the measurement properties of the instrument will then be tested in a cross-sectional observational study. On task 2, the Carer Support Needs Assessment Tool v3.0 and the Preparedness for Caregiving Scale will also be translated to European Portuguese.

Adults who are diagnosed with CRD, who are fluent in Portuguese and identify an informal/family carer will be included. If they show signs of cognitive impairment, they will not be eligible for the interviews. Informal carers will be included in the study if they are ≥18 years old and are fluent in Portuguese. They will be excluded if they show signs of cognitive impairment. Health professionals will be included if they contact with people with CRD in their clinical practice.

Sociodemographic and general clinical data will be collected. Instruments assessing cognitive impairment, functional capacity, disease's impact, health related quality of life, health status, level of anxiety and depression, satisfaction with life, social network, functionality, burden, positive aspects of caregiving, preparedness for caregiving, health literacy and informal carers' needs, as well as questions regarding care, will be applied. Interviews will be conducted.

Sample size will be determined by the saturation of qualitative data in task 2. For the assessment of health literacy of informal carers of people with CRD, it is not possible to determine the sample number. The maximum number of informal carers will be recruited and estimates a posteriori will be made. For task 3, following the Consensus-based Standards guidelines for the Selection of health status Measurement Instruments (COSMIN), a minimum of 100 participants will be required.

Data analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) software. For the organization and visualization/analysis of qualitative data, the NVivo program will be used. Descriptive statistics, comparison of distributions, and associations. Validity and reliability will be assessed. The analysis of qualitative data will be divided into content analysis and thematic analysis.

Connect with a study center

  • University of Aveiro

    Aveiro, 3810-193
    Portugal

    Active - Recruiting

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