Ignite Creation Date:
2024-05-06 @ 6:10 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05572346
Status:
RECRUITING
Last Update Posted:
2023-01-10
First Post:
2022-10-03
Brief Title:
Digital App for Telerehabilitation in Respiratory Diseases
Sponsor:
MedicAir Healthcare Srl
Organization:
MedicAir Healthcare Srl
Study Overview
Official Title:
Use of a Digital App to Deliver Home-based Rehabilitative Interventions in Patients Affected by Respiratory Diseases a Monocentric Observational Study
Status:
RECRUITING
Status Verified Date:
2023-01
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:
The purpose of this study is to evaluate the feasibility and the mid-term effects of a pulmonary rehabilitation intervention delivered by digital App on quality of life of patients affected by respiratory diseases The App will include a monitored exercise training program based on most recent cardiopulmonary rehabilitation guidelines including alerts reminders and educational contents as well as chat and online visits with healthcare professionals to improve patient engagement
Detailed Description:
The center-based pulmonary rehabilitation PR intervention is considered the gold standard for functional recovery secondary prevention quality of life improvement and social as well as work reintegration in patients affected by respiratory diseases Such kind of intervention when delivered in all its fundamental components clinical stabilization functional assessment physical and respiratory training counseling nutritional intervention and psychosocial support is able to reduce global mortality and is recommended by the major international guidelines
Despite the high level of recommendation only a small fraction of patients after the acute hospital phase is currently initiated to PR programs for several reasons including the limited number of specialized rehabilitation facilities
This unmet need can cause a potential damage to patients health failure to reduce disability higher risk of further pathological relapses and generates an increase in social and healthcare costs especially related to subsequent hospitalizations and loss of working capacity
In order to fill the gap between PR need and demand health systems are have to adopt not only organizational changes but also to implement innovative solutions based on new technologies In particular wearables and mobile health devices seem to be promising tools to deliver a sort of light PR intervention promoting healthier lifestyle even in the long term
Primary aim The primary objective of the study is to evaluate the feasibility and the medium-term effect on quality of life measured by Visual Analogue Scale VAS contained in the EuroQoL 5D-5L questionnaire of a digital home-based telerehabilitation program in patients with chronic obstructive pulmonary disease COPD asthma bronchiectasis pulmonary fibrosis obesity and long COVID syndrome
Secondary aims The secondary objectives are to evaluate the impact of the intervention on functional capacity through the Six-Minute Walking test 6MWT evaluate changes in dyspnea perception evaluate the impact of the intervention on spirometric indices evaluate adherence to the intervention delivered via digital app evaluate usability satisfaction adverse events and exacerbations during the intervention delivered through the digital app
Study design Monocentric before-after study Assessment a baseline T0 and after 8 weeks of intervention T1
Population 30 patients discharged from the Pulmonary Rehabilitation Unit of ICS Maugeri - IRCCS Lumezzane Lumezzane - BS Italy affected by COPD asthma pulmonary fibrosis bronchiectasis obesity or long COVID syndrome
Inclusion criteria Age 18 years old Diagnosis of COPD with Tiffenau index 70 FEV1 80 asthma bronchiectasis pulmonary fibrosis obesity BMI 30 long COVID syndrome Mini-mental status examination 22 Ability to perform a 6MWT with or without assistive devices Patients discharged from the Unit less than two weeks before the enrollment Written informed consent
Exclusion criteria Simultaneous participation to other research projects Simultaneous participation to other rehabilitation interventions High risk of heart failure andor ventricular dysfunction High thrombotic risk Cardiac surgery within 3 months after the study enrollment High risk of arrhythmias Atrial fibrillation Moderate to severe valvulopathy Severe or not adequately controlled respiratory diseases Hemodynamic instability Anemia Hb 10 gdl Pregnancy History of drugs abuse Total or partial inability to use digital devices Barriers to exercise training completion Full-day ventilotherapy
Materials and methods
At the hospital discharge T0 a digital kit will be delivered in order to perform a home-based monitored telerehabilitation program Using this kit participants will undergo an 8-weeks exercise training and educational program to preserve the rehabilitative outcomes gained during hospital rehabilitation phase
Every week participants will undergo a video-coaching session with a respiratory physiotherapist
Primary endpoint Changes EuroQoL 5D-5L VAS score
Secondary endpoint Change in COPD Assessment Test CAT and EuroQoL VAS excluded scores Variation of 6MWT performance at 8 weeks T1 compared to T0 Variations of mean maximal and at rest saturation during 6MWT at T1 compared to T0 Variations of mean maximal and at rest heart rate as well as fatigue perception during 6MWT at T1 compared to T0 Change in Barthel Dyspnea and Medical Research Council MRC scores Variations of spirometric parameters FVC FEV1 Tiffeneau index FEF75 FEF50 FEF25 FEF25-75 Adherence number of sessions completednumber of sessions programmed ratio Satisfaction and user experience assessment with Technology Acceptance Model TAM Assessment of adverse events and number of pathological relapses
Sample size Considering a Minimal Clinical Important Difference of 8 points at EuroQoL VAS a standard deviation of 15 points an alpha error of 5 and a power of 80 the estimated sample size will be of 30 participants
Statistical analysis Data will be synthetized using descriptive statistics quantitative variables will be summarized with means and standard deviations or medians and interquartile ranges as appropriate categorical variables will be expressed as absolute frequencies and percentages
To assess outcomes changes following the 8-weeks intervention parametric and non-parametric within group tests will be applied as appropriate
Correlations between variables will be assessed using partial correlation analysis
All the analyses will be conducted using SPSS 26 IBM Armonk NY USA
Ethical and regulatory considerations This study will be conducted in accordance with the principles laid down by the 18th World Medical Assembly Helsinki 1964 and all applicable amendments laid down by the World Medical Assemblies and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ICH guidelines for Good Clinical Practice
Despite the high level of recommendation only a small fraction of patients after the acute hospital phase is currently initiated to PR programs for several reasons including the limited number of specialized rehabilitation facilities
This unmet need can cause a potential damage to patients health failure to reduce disability higher risk of further pathological relapses and generates an increase in social and healthcare costs especially related to subsequent hospitalizations and loss of working capacity
In order to fill the gap between PR need and demand health systems are have to adopt not only organizational changes but also to implement innovative solutions based on new technologies In particular wearables and mobile health devices seem to be promising tools to deliver a sort of light PR intervention promoting healthier lifestyle even in the long term
Primary aim The primary objective of the study is to evaluate the feasibility and the medium-term effect on quality of life measured by Visual Analogue Scale VAS contained in the EuroQoL 5D-5L questionnaire of a digital home-based telerehabilitation program in patients with chronic obstructive pulmonary disease COPD asthma bronchiectasis pulmonary fibrosis obesity and long COVID syndrome
Secondary aims The secondary objectives are to evaluate the impact of the intervention on functional capacity through the Six-Minute Walking test 6MWT evaluate changes in dyspnea perception evaluate the impact of the intervention on spirometric indices evaluate adherence to the intervention delivered via digital app evaluate usability satisfaction adverse events and exacerbations during the intervention delivered through the digital app
Study design Monocentric before-after study Assessment a baseline T0 and after 8 weeks of intervention T1
Population 30 patients discharged from the Pulmonary Rehabilitation Unit of ICS Maugeri - IRCCS Lumezzane Lumezzane - BS Italy affected by COPD asthma pulmonary fibrosis bronchiectasis obesity or long COVID syndrome
Inclusion criteria Age 18 years old Diagnosis of COPD with Tiffenau index 70 FEV1 80 asthma bronchiectasis pulmonary fibrosis obesity BMI 30 long COVID syndrome Mini-mental status examination 22 Ability to perform a 6MWT with or without assistive devices Patients discharged from the Unit less than two weeks before the enrollment Written informed consent
Exclusion criteria Simultaneous participation to other research projects Simultaneous participation to other rehabilitation interventions High risk of heart failure andor ventricular dysfunction High thrombotic risk Cardiac surgery within 3 months after the study enrollment High risk of arrhythmias Atrial fibrillation Moderate to severe valvulopathy Severe or not adequately controlled respiratory diseases Hemodynamic instability Anemia Hb 10 gdl Pregnancy History of drugs abuse Total or partial inability to use digital devices Barriers to exercise training completion Full-day ventilotherapy
Materials and methods
At the hospital discharge T0 a digital kit will be delivered in order to perform a home-based monitored telerehabilitation program Using this kit participants will undergo an 8-weeks exercise training and educational program to preserve the rehabilitative outcomes gained during hospital rehabilitation phase
Every week participants will undergo a video-coaching session with a respiratory physiotherapist
Primary endpoint Changes EuroQoL 5D-5L VAS score
Secondary endpoint Change in COPD Assessment Test CAT and EuroQoL VAS excluded scores Variation of 6MWT performance at 8 weeks T1 compared to T0 Variations of mean maximal and at rest saturation during 6MWT at T1 compared to T0 Variations of mean maximal and at rest heart rate as well as fatigue perception during 6MWT at T1 compared to T0 Change in Barthel Dyspnea and Medical Research Council MRC scores Variations of spirometric parameters FVC FEV1 Tiffeneau index FEF75 FEF50 FEF25 FEF25-75 Adherence number of sessions completednumber of sessions programmed ratio Satisfaction and user experience assessment with Technology Acceptance Model TAM Assessment of adverse events and number of pathological relapses
Sample size Considering a Minimal Clinical Important Difference of 8 points at EuroQoL VAS a standard deviation of 15 points an alpha error of 5 and a power of 80 the estimated sample size will be of 30 participants
Statistical analysis Data will be synthetized using descriptive statistics quantitative variables will be summarized with means and standard deviations or medians and interquartile ranges as appropriate categorical variables will be expressed as absolute frequencies and percentages
To assess outcomes changes following the 8-weeks intervention parametric and non-parametric within group tests will be applied as appropriate
Correlations between variables will be assessed using partial correlation analysis
All the analyses will be conducted using SPSS 26 IBM Armonk NY USA
Ethical and regulatory considerations This study will be conducted in accordance with the principles laid down by the 18th World Medical Assembly Helsinki 1964 and all applicable amendments laid down by the World Medical Assemblies and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ICH guidelines for Good Clinical Practice
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