Clinical trial NCT06492590: Long COVID-19 Intervention (COVIDL/MIQoL)
Official title: Assessing a Multicomponent Intervention to Improve Quality of Life in Individuals With Long COVID-19 (COVIDL/MIQoL): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Long COVID-19
Keywords: Physical Rehabilitation
Psychological Intervention
Randomized Controlled Trial
Long COVID-19
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a Randomized controlled trial with parallel arms. Participants will be randomly allocated either to an intervention group or control by the external researcher using computer-generated random numbers
Primary purpose: SUPPORTIVE_CARE

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).

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 patients\&amp;#39; 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 34 participants in each group, using GRANMO (https://www.imim.es/ofertadeserveis/software-public/granmo/). A follow-up loss rate of 10% was estimated.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with Long COVID-19
* Present discomfort with the situation
* Individuals aged 18 to 75
* Sign the informed consent form

Exclusion Criteria:

* Severe sensory deficits
* Physical illnesses that do not allow attendance at the sessions
* Severe mental disorders that make participation in groups inadvisable
* Travel, surgery, or other event that does not allow at least 80% of the sessions
* No comprehension of the language

Primary outcomes:
measure: Improved quality of life
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
Secondary outcomes:
measure: Improve well-being
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
measure: Decreased anxiety and depression
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
measure: Increased resilience
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
measure: Improve physical activity
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
measure: Decreased fatigue
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Primary Health Care, Consorci Sanitari de Terrassa
name: Maria Llistosella, PhD
role: PRINCIPAL_INVESTIGATOR
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