Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492590
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Long COVID-19 Intervention COVIDLMIQoL
Sponsor:
Consorci Sanitari de Terrassa
Organization:
Consorci Sanitari de Terrassa
Study Overview
Official Title:
Assessing a Multicomponent Intervention to Improve Quality of Life in Individuals With Long COVID-19 COVIDLMIQoL A Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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:
COVIDLMIQoL
Brief Summary:
The goal of this clinical trial is to assess the effectiveness of a multicomponent intervention in individuals with Long COVID The main questions it aims to answer are
Does the intervention increase quality of life mental well-being resilience and physical condition in individuals with Long COVID
Does the intervention decrease anxiety depressed mood and fatigue in individuals with Long COVID The researchers will compare the multicomponent intervention with a control non-intervention group
Participants will
Participate in a multicomponent intervention for 9 weeks 2 sessions each week one of psycho-education and one of physical rehabilitation
Does the intervention increase quality of life mental well-being resilience and physical condition in individuals with Long COVID
Does the intervention decrease anxiety depressed mood and fatigue in individuals with Long COVID The researchers will compare the multicomponent intervention with a control non-intervention group
Participants will
Participate in a multicomponent intervention for 9 weeks 2 sessions each week one of psycho-education and one of physical rehabilitation
Detailed Description:
Background The persistence of symptoms after acute SARS-CoV-2 infection known as Long COVID has emerged as a wide-ranging public health challenge This condition characterised by a wide range of physical and psychological symptoms that persist months after initial recovery significantly affects patientsamp39 quality of life
To our knowledge in the Primary Health Care setting there are few published clinical trials of multicomponent interventions involving psycho-educational and physical rehabilitation activities to improve quality of life of individuals with Long COVID Therefore the purpose of this trial is to assess the effectiveness of an innovative multicomponent intervention which includes psycho-education and physical rehabilitation and which is in line with the complex needs of individuals with Long COVID
The investigators hypothesize that participants with Long COVID who receive the multicomponent intervention psycho-education and physical rehabilitation will increase their quality of life mental well-being resilience and physical condition and decreased anxiety depressed mood and fatigue compared to the control group
Method The study is a Randomized Controlled Trial RCT Participants will sign an agreement to participate in the study and will be randomly allocated in control and intervention groups by external researcher using a computer-generated random number
The intervention will be carried out during January 2025- September 2025 Participants will follow a specific training consisting of 18 sessions 9 sessions psycho-education of 90 minutes one per week conducted by specialized therapist and 9 sessions physical rehabilitation of 60 minutes one per week conducted by an expert physiotherapist
The data collection will start in January 2025 and will finish in September 2025 Data will be collected at baseline before the intervention T0 after 9 weeks post-intervention T1 and 24 weeks follow-up T2
The assessment of the effectiveness of the intervention will be carried out using the psychometric scale EuroQol5D-5L as the primary outcome which will allow the investigators to determine changes in quality of live
Using SD of the primary outcome EuroQol5D-5L minimum sample size was calculated to be 54 participants in each group using GRANMO httpswwwimimesofertadeserveissoftware-publicgranmo A follow-up loss rate of 10 was estimated
To our knowledge in the Primary Health Care setting there are few published clinical trials of multicomponent interventions involving psycho-educational and physical rehabilitation activities to improve quality of life of individuals with Long COVID Therefore the purpose of this trial is to assess the effectiveness of an innovative multicomponent intervention which includes psycho-education and physical rehabilitation and which is in line with the complex needs of individuals with Long COVID
The investigators hypothesize that participants with Long COVID who receive the multicomponent intervention psycho-education and physical rehabilitation will increase their quality of life mental well-being resilience and physical condition and decreased anxiety depressed mood and fatigue compared to the control group
Method The study is a Randomized Controlled Trial RCT Participants will sign an agreement to participate in the study and will be randomly allocated in control and intervention groups by external researcher using a computer-generated random number
The intervention will be carried out during January 2025- September 2025 Participants will follow a specific training consisting of 18 sessions 9 sessions psycho-education of 90 minutes one per week conducted by specialized therapist and 9 sessions physical rehabilitation of 60 minutes one per week conducted by an expert physiotherapist
The data collection will start in January 2025 and will finish in September 2025 Data will be collected at baseline before the intervention T0 after 9 weeks post-intervention T1 and 24 weeks follow-up T2
The assessment of the effectiveness of the intervention will be carried out using the psychometric scale EuroQol5D-5L as the primary outcome which will allow the investigators to determine changes in quality of live
Using SD of the primary outcome EuroQol5D-5L minimum sample size was calculated to be 54 participants in each group using GRANMO httpswwwimimesofertadeserveissoftware-publicgranmo A follow-up loss rate of 10 was estimated
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