Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459011
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-09
Brief Title:
TAKINGCARE - TAcKlING the Needs of Loved Ones of People With Chronic respirAtoRy disEases
Sponsor:
Aveiro University
Organization:
Aveiro University
Study Overview
Official Title:
TAKINGCARE - TAcKlING the Needs of Loved Ones of People With Chronic respirAtoRy disEases
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 informalfamily 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 hospitalsUnidade Local de Saúde de GaiaEspinho 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
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 hospitalsUnidade Local de Saúde de GaiaEspinho 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
Detailed 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 informalfamily 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 psychologicalemotional social and spiritual support It is assumed that informalfamily 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 eg personal growth satisfaction there has been an acknowledgement of negative impacts eg burden difficulty in realizing personal interestsprojects and specific needs related to their roles Nevertheless their needs are usually unmet and rarely assessed and they are highly neglected by the socialhealth 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 Unions 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 informalfamily 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 GaiaEspinho 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 informalfamily 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 v30 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 informalfamily 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 diseases 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 visualizationanalysis 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
Daily informalfamily 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 psychologicalemotional social and spiritual support It is assumed that informalfamily 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 eg personal growth satisfaction there has been an acknowledgement of negative impacts eg burden difficulty in realizing personal interestsprojects and specific needs related to their roles Nevertheless their needs are usually unmet and rarely assessed and they are highly neglected by the socialhealth 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 Unions 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 informalfamily 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 GaiaEspinho 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 informalfamily 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 v30 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 informalfamily 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 diseases 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 visualizationanalysis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None