LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease

Interstitial Lung Diseases Clinical Trial

— SUNSET  

Official title:

LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease - the SUNSET Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317831
• Other study ID #: 2023.03936.BDANA
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: July 30, 2028

Study information

• Verified date: April 2024
• Source: Aveiro University
• Contact: Alda S. Marques, PhD
• Phone: 00351 234 372 462
• Email: amarques[@]ua.pt
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to i) To characterize the functional status and explore the determinants of functional status decline of people with IlD ii)To determine the measurement properties of functional status instruments in people with Interstitial lung diseases (ILD) iii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iv) Explore the progression of functional status progression in people with ILD and v) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.

Patients with ILD will be recruited via the pulmonology services at hospitals, namely from Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up spirometric measurements and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.

The assessments will be conducted at 6 time points: baseline and 1 week after for instrument validation, followed by assessments every 6 months for 2 years.

It is expected that: i) Functional status limitations can be comprehensively identified and measured in individuals with ILD. ii) Some measures are valid and reliable indicators of functional status in individuals with ILD. iii) Different profiles of functional status progression will be identified in individuals with ILD, including stable, slow, and fast decline. iv) A multidimensional index incorporating functional status will improve the accuracy of predicting mortality and outperform the predictive ability of the current GAP Index.

Description:

Functional status is a fundamental, patient-centred and multidimensional outcome for individuals with interstitial lung disease (ILD). Functional status decline is the most frequent impact reported in this population. It is often associated with an increased dependency on others, loss of productivity and premature death. It is also an important predictor of exacerbations, hospitalisations, readmissions, and mortality. Functional status decline is so overwhelming for individuals and society, that it has been recently recognised as an international top priority for patient-centred research in ILD. Yet, little is known how functional status is impaired and progresses in ILD, limiting the help health professionals are able to provide to optimise care.

ILD are a highly disabling group of chronic respiratory diseases characterised by widespread inflammation and scarring (fibrosis) of the lung. In people with ILD, the destruction of the pulmonary capillary bed and vasoconstriction, results in impaired gas exchange and circulatory limitation, which can lead to reduced exercise capacity. Exercise capacity may be further limited due to peripheral muscle dysfunction caused by physical deconditioning and drug-induced myopathy from ILD treatment with corticosteroids. Taken together these factors contribute to the high symptom burden experienced. This population, therefore, presents pulmonary (e.g., dyspnoea, cough) and extra-pulmonary (e.g., decreased exercise tolerance, skeletal muscle dysfunction, fatigue) traits and experience a downward spiral of debilitating symptoms and functional status decline.

Functional status is defined as the ability to perform normal daily activities required to meet basic needs, fulfil usual roles, and maintain health and well-being. It includes functional capacity, i.e., an individual's maximum capacity to perform daily life activities in a standardized environment; and functional performance, i.e., activities people actually do during the course of their daily life. Adequate assessment of functional status must, therefore, include measures of functional capacity and performance, to identify the presence or absence of decline and inform on preventive and/or rehabilitative strategies. Studies focussing on the comprehensive assessment of functional status in people with ILD using reliable and validated instruments are, however, lacking.

Therefore, the primary aim of SUNSET study is to characterize the functional status and explore the determinants of functional status decline of people with ILD.

Secondary aims are to: i) To determine the measurement properties of functional status instruments in people with ILD ii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iii) Explore the progression of functional status progression in people with ILD and iv) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.

According to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline, a minimum sample size of 100 will be required for task 1.

For task 2, number of participants needed for interviews will be determined by data saturation.

For task 3, a sample size estimation was performed in GPower to detect a small effect size (eta^2=0.02), with 80% power, 5% significance level and moderate correlation among repeated measures (r=0.5) in a repeated measures analysis of variance. The minimum sample size estimation was 81 participants Considering a dropout rate of 50%, we will aim to recruit 122 participants.

This study is a multicentric observational longitudinal research project comprising four tasks. It involves collaboration between institutions, namely the University of Aveiro, along with three healthcare facilities: Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV), and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Task 1 aims to validate the measures of functional status. For this, two assessment moments will be performed. The first assessment will be conducted at baseline and will be in line with the routine appointment. The second assessment will be conducted 7 days after baseline. Task 2 will use the information collected in Task 1 and conduct semi-structured individual interviews to characterize the functional status from the perspective of people with ILD. Task 3 will then conduct an observational longitudinal study using the most valid and reliable measures of functional status identified in task 1 and mortality rates will be explored during task 3. For this, patients will be contacted to participate in four timepoints of assessment (at 6, 12, 18, and 24 months) which will be in line with the routine appointment. Table 1 details the measurements performed in each timepoint. If an outcome measure is found to not be valid and reliable during task 1, that outcome measure will not be collected in task 3 nor replaced by another outcome measure. In Task 4, the data collected in Task 3 will be used to develop a multidimensional index incorporating functional status parameters to predict mortality in people with ILD. The study assessments will take approximately 90 minutes and will take place at Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV), and Centro Hospitalar de Entre o Douro e Vouga (CHEDV).

Patients with ILD will be recruited via the pulmonology services at hospitals. Pulmonologists will explain the study briefly and inform the researchers about interested participants. The researchers will provide further information about the study, clarify any doubts and collect the informed consent. Participants will be eligible if they are: i) ≥18 years, ii) diagnosed with any type of ILD, iii) fluent in Portuguese and iv) able to provide informed consent. Participants will be excluded if they have: i) other respiratory diseases ii) a history of acute cardiac/respiratory condition in the previous month; iii) present signs of cognitive impairment; iv) significant cardiovascular, neurological and/or musculoskeletal disease that may limit their participation; v) current neoplasia, vi) other autoimmune diseases (aside from ILD). Once task 1 is finished, included participants will be contacted again to verify if they still match the inclusion/exclusion criteria and are still willing to participate in task 3.

Baseline data will be collected: Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up lung function and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.

Data analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) software, incorporating both descriptive and inferential statistics. To examine changes in outcome measures, data from baseline and subsequent assessments will be compared. Additionally, the interviews will be transcribed and analysed using thematic analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 30, 2028
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years

• Diagnosed with any type of ILD

• Fluent in Portuguese

• Able to provide informed consent.

Exclusion Criteria:

• Other respiratory diseases

• A history of acute cardiac/respiratory condition in the previous month

• Present signs of cognitive impairment

• Significant cardiovascular, neurological and/or musculoskeletal disease that may limit their participation

• Current neoplasia

• Other autoimmune diseases (aside from ID).

Related Conditions & MeSH terms

• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
Portugal	University of Aveiro	Aveiro

Sponsors (2)

Lead Sponsor	Collaborator
Aveiro University	Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	The participants' weight will be assessed in kilograms.	One measurement will be assessed in each timepoint (6 months, 12 months, 18 months and 24 months)
Other	Height	The participants' weight will be assessed in meters.	One measurement will be assessed in each timepoint (6 months, 12 months, 18 months and 24 months)
Other	Body mass index	Patients' body mass index will be assessed in kg/m^2 based on patients' height and weight.	One measurement will be assessed in each timepoint.
Other	Heart rate	Heart rate will be assessed in beats per minute using a oximeter and blood pressure meter.	One measurement will be assessed in each timepoint.
Other	Respiratory rate	Respiratory rate will be assessed by direct observation, counting the number of respiratory cycles.	One measurement will be assessed in each timepoint.
Other	Blood pressure	Blood pressure (systolic and diastolic) will be assessed using a blood pressure meter.	One measurement will be assessed in each timepoint.
Other	Peripheral Oxygen Saturation	Peripheral oxygen saturation will be assessed with a pulse oximeter.	The measurements will be collected before and after the six-minute walk test in each timepoint (6 months, 12 months, 18 months and 24 months)
Primary	Short physical performance battery (SPPB)	Patients' functional level will be assessed with the short physical performance battery, a simple and easy to perform tool that includes the four-meter gait speed test, the five-repetition sit-to-stand test and a balance test, and gives a total score based on the performance in each of those tests.	Two measurements will be assessed at baseline and one at each follow-up (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Six Minute Walk Test (6MWT)	The Six Minute Walk Test is the gold standard exercise test and has been validated in people with ILD and is commonly used to assess functional status. The 6MWD is valid and reliable measure in people with ILD, with excellent intra-class correlation coefficients (ICCs= 0.82-0.99).	Only one measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months).
Secondary	The 1-minute sit-to-stand	The 1-minute sit-to-stand test will be used to also assess functional status.	Two measurements will be assessed at baseline and one at each follow-up (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	The grocery shelving task	The grocery shelving task is valid, reliable and responsive functional outcome measure that incorporates unsupported arm activity in patients with chronic respiratory disease.	Two measurements will be conducted in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months) due to the presence of a learning effect with this test.
Secondary	The Physical Performance Test (PPT)	The Physical Performance Test (PPT) is valid and reliable established measure of physical function status.	Two measurements will be assessed at baseline and one at each follow-up (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Handgrip strenght	Participants' isometric handgrip muscle strength will be evaluated using a hydraulic hand dynamometer and measured in kilograms.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Peripheral muscle strength	Participants' isometric biceps and quadriceps muscle strength will be collected with a hand-held dynamometer and measured in kilogram-force.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months).
Secondary	The Tilburg Frailty Indicator (TFI)	The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people and has been used in people with chronic obstructive pulmonary disease. TFI is valid and reliable instrument to assess frailty.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	The Canadian Occupational Performance Measure (COPM)	The Canadian Occupational Performance Measure (COPM) is a reliable and responsive measure of a client's self-perception of occupational performance in the areas of self-care, productivity, and leisure. It has been used in chronic obstructive pulmonary disease.	Three measurements will be assessed at baseline and one at each follow-up (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Symptoms of fatigue	The level of fatigue on a daily basis will be collected with the Checklist of Individual Strength 8 (CIS-8).	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Symptoms of fatigue	Patients' self-reported level of fatigue will be collected at rest, using the modified Borg scale.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Symptoms of dyspnoea	Patients' self-reported level of dyspnoea will be collected at rest, using the modified Borg scale.	One measurement will be assessed in each timepoint (baselinre, 6 months, 12 months, 18 months and 24 months)
Secondary	The Pulmonary Functional Status and Dyspnea Questionnaire Modified version (PFSDQ-M)	The Pulmonary Functional Status and Dyspnea Questionnaire Modified version (PFSDQ-M) is a disease specific questionnaire with three domains: influence of dyspnea during activity of daily living (ADL), influence of fatigue on ADLs and change experienced by the patient in ADLs. Is valid and reliable questionnaire to assess ADL limitations in patients with COPD chronic obstructive pulmonary disease.	Three measurements will be assessed at baseline and one at each follow-up (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Health-related quality of life (HRQOL)	The King's Brief Interstitial Lung Disease (K-BILD) will be used to evaluate health-related quality of life in individuals with interstitial lung disease	Only one measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Health-related quality of life (HRQOL)	The St George's Respiratory Questionnaire on Respiratory Pulmonary Fibrosis version (SGRQ-i), will be used to assess health-related quality of life in individuals with interstitial lung disease	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	London Chest Activities of Daily Living (LCADL)	Patients' level of dyspnoea performing activities of daily living and functional status will be assessed with th London Chest Activities of Daily Living questionnaire.	Only one measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Daily physical activity	Physical activity will be objectively quantified, as an exploratory outcome, for managing the influence of physical activity on functional status assessment, with an Actigraph GT3X (Actigraph LLC Pensacola, FL, USA).	Only one measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Qualitative data: Interviews	participants will be invited to take part in face-to-face, semi-structured individual interviews to understand the impact of ILD and participants' perspectives on functional status.	Only one measurement will be assessed at baseline (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Number of hospitalizations	Patients' number of hospitalizations in the previous year and during the follow-up period, as well as the length of stay for each hospitalization, will be assessed by asking the patient to self-report.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Acute exacerbations	Patients' number of acute exacerbations will be assessed by asking the patient to self-report.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Non-invasive ventilation	The patients' use of non-invasive ventilation will be assessed by asking them to self-report.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Oxygen therapy	The patients' use of oxygen therapy will be assessed by asking them to self-report.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Medication	The patients' medication will be assessed by asking them to self-report.	One measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months)
Secondary	Mortality	Patients who died after being included in the study will be identified by consulting the pneumologists.	One measurement will be assessed in each timepoint (6 months, 12 months, 18 months and 24 months)