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

NCT06459011 | Recruiting

• 1 other identifier: PRT/BD/154726/2023
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Respiratory Disease

Keywords

chronic respiratory disease; needs; informal care; loved ones; health literacy; measurement properties; preparedness for caregiving

Outcome Measures

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.

  Task 2 and 3 (baseline)

Secondary Outcomes (15)

• Six Minute Walk Test (6MWT)

  Task 2 and 3 (baseline)

• : Chronic Airways Assessment Test (CAAT)

  Task 2 and 3 (baseline)

• King's Brief Interstitial Lung Disease (KBILD)

  Task 2 and 3 (baseline)

• 5-level EuroQoL-5D (EQ-5D-5L)

  Task 2 and 3 (baseline)

• Hospital Anxiety and Depression Scale (HADS)

  Task 2 and 3 (baseline)

Other Outcomes (4)

• Sociodemographic data

  Task 2 and 3 (baseline)

• Clinical data

  Task 2 and 3 (baseline)

• Anthropometric data

  Task 2 and 3 (baseline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with chronic respiratory diseases, informal carers of people with chronic respiratory diseases, and health professionals

You may qualify if:

• People with chronic respiratory diseases (CRD):
• 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:
• years of age or older;
• Fluent in Portuguese.
• Health Professionals:
• Fluent in Portuguese;
• Contact with people with CRD in their clinical practice.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

RECRUITING

Related Publications (27)

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  PMID: 28741373 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

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• Tomaszewski EL, Atkinson MJ, Janson C, Karlsson N, Make B, Price D, Reddel HK, Vogelmeier CF, Mullerova H, Jones PW; NOVELTY Scientific Community; NOVELTY study investigators. Chronic Airways Assessment Test: psychometric properties in patients with asthma and/or COPD. Respir Res. 2023 Apr 8;24(1):106. doi: 10.1186/s12931-023-02394-6.

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Related Links

• World Health Organization (WHO). The top 10 causes of death. World Health Organization 2020
• Marques A, Goldstein RS. Living with chronic lung disease: The experiences and needs of patients and caregivers. Pulmonary Rehabilitation 2020:281.
• Eurocarers. Enabling carers to care: An EU strategy to support and empower informal carers. European Association working for carers 2023
• World Health Organization. Measuring Health and Disability Manual for WHO Disability Assessment Schedule.; 2010

Study Officials

• Alda S Marques, PhD

  School of Health Sciences of the University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alda S Marques, PhD

CONTACT

00351 234 372 462; amarques@ua.pt

Odete M Alves, MSc

CONTACT

00351 234 372 476; odete.alves@ua.pt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 14, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)