Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundació Institut Germans Trias i Pujol | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this study is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment in people with Post-COVID-19 Condition.
The main question it aims to answer is whether participants assigned to SuperCAP experience a greater reduction in disability, defined as an improvement of at least 5 points on the WHODAS 2.0 from baseline to the post-intervention visit, compared with participants in the control group.
Participants assigned to the SuperCAP intervention will undergo a series of sessions that include psychoeducation, adaptive cognitive training exercises, fatigue self-management strategies, and multidisciplinary content.
-COVID-19 Condition (PCC) is a major public health challenge, with cognitive impairment and fatigue among its most prevalent and disabling symptoms, leading to substantial limitations in quality of life and daily functioning. Digital health solutions provide an opportunity to expand access to structured, evidence-informed care. SuperCAP was developed as a multidisciplinary digital therapeutic program to support cognitive and functional recovery in individuals with PCC. A randomized pilot study demonstrated its feasibility and acceptability, supporting the conduct of a larger randomized controlled trial to evaluate its efficacy on disability and cognitive outcomes.
Participants will be randomized (1:1) to receive the digital intervention (SuperCAP) or Standard of Care (SoC) during 13 weeks, followed by a 12-week observation period.
The primary objective is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment.
The secondary objectives include evaluating the effects of SuperCAP on quality of life, daily functioning, cognitive and emotional outcomes, the durability of these effects at follow-up, and the feasibility and acceptability of program implementation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SuperCAP Arm | Experimental | The intervention comprises 60 sessions delivered over 12 weeks (5 sessions/week), with flexibility up to 15 weeks to accommodate symptom fluctuation. Each session follows a standardized structure to reinforce self-management and cognitive engagement. The sessions includes psychoeducation, adaptive cognitive training exercises, fatigue self-management strategies, and multidisciplinary content. |
|
| Standard of Care Arm | Active Comparator | The Standard of Care consists in a psychoeducational intervention on the cognitive disorders and fatigue associated with long COVID, and general guidelines on how to manage these symptoms so that they have the least possible impact on daily life. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SuperCAP intervention program | Device | The SuperCAP (Supervised Computerized Active Program) is an online, multidimensional therapeutic program integrated into eSalut, the Catalan Institute of Health's digital platform, designed to improve daily functioning and quality of life in individuals with PCC who experience cognitive symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether the SuperCAP intervention program is superior to control in reducing disability. | Change in total WHODAS 2.0 score from baseline to post-intervention. | From baseline (week 0) to the post-intervention assessment (week 13). |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether the SuperCAP intervention leads to greater improvements in quality of life compared with control. | Change in EuroQol 5 Dimensions (EQ-5D) score from -0,654 to 1 where higher scores mean better outcome. | From baseline (week 0) to post-intervention (week 13) |
| To assess whether the SuperCAP intervention leads to greater improvements in instrumental daily functioning compared with control. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Prats, PhD | Contact | +34934657897 | aprats@lluita.org | |
| David Rovira | Contact | +34934978849 | drovira@scienhub.org |
| Name | Affiliation | Role |
|---|---|---|
| Anna Prats, PhD | Fundació Lluita contra les Infeccions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
The individual participant data (IPD) will not be shared publicly due to the nature of the study, the limited sample size, and the sensitive nature of the data related to cognitive status of the participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Psychoeducational intervention | Other | The psychoeducational intervention is a non-pharmacological interventions that teach practical strategies to help individuals with the cognitive disorders and fatigue associated with long COVID and provide general guidelines on how to manage these symptoms so that they have the least possible impact on daily life. |
|
Change in Instrumental Activities of Daily Living (IADL) score from 0 to 8 where higher score mean better outcomes. |
| From baseline (week 0) to post-intervention (week 13). |
| To evaluate whether the intervention improves performance-based cognitive measures. | Change in Montreal Cognitive Assessment (MoCA) total score from 0 to 30 where higher scores mean better outcomes. | From baseline (week 0) to post-intervention (week 13). |
| To evaluate whether the intervention improves patient-reported cognitive functioning. | Change in subjective cognitive functioning in daily life by Memory Failures of Everyday Questionnaire (MFE-30) with scores from 0 to 120 where higher scores mean worse outcomes. | From baseline (week 0) to post-intervention (week 13). |
| To assess reductions in depressive symptoms following the intervention. | Change in Patient Health Questionnaire-9 (PHQ-9) with scores from 0 to 27 where higher scores means worse outcomes. | From baseline (week 0) to post-intervention (week 13) |
| To assess reductions in anxiety symptoms following the intervention. | Change in Generalized Anxiety Disorder-7 (GAD-7) score from 0 to 21 where higher scores mean worse outcomes. | From baseline (week 0) to post-intervention (week 13). |
| To determine whether improvements in functional outcomes are sustained at follow-up. | Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) score from 0 to 144 where higher scores mean worse outcomes. | From post-intervention (week 13) to follow-up (week 25). |
| To determine whether improvements in cognitive outcomes are sustained at follow-up. | Change in Montreal Cognitive Assessment (MoCA) score from 0 to 30 where higher scores mean better outcomes. | From post-intervention (week 13) to follow-up (week 25). |
| To determine whether improvements in emotional outcomes are sustained at follow-up. | Change in EuroQol 5 Dimensions (EQ-5D) score from -0,654 to 1 where higher scores mean better outcomes. | From post-intervention (week 13) to follow-up (week 25). |
| To evaluate feasibility of implementation, including adherence to the program. | Program adherence captured through platform telemetry. | From post-intervention (week 13) to follow-up (week 25) |
| To evaluate feasibility of implementation, including usability. | Usability measured by System Usability Score (SUS) score from 0 to 100 where higher scores mean better outcomes. | From post-intervention (week 13) to follow-up (week 25) |
| To evaluate feasibility of implementation, including satisfaction and retention. | Participant satisfaction and perceived benefit will be assessed through a brief set of items evaluating overall satisfaction with the program, perceived usefulness and perceived improvement in daily functioning. | From post-intervention (week 13) to follow-up (week 25). |
| To explore indicators of acceptability. | Acceptability assessed using the Acceptability of Intervention Measure (AIM) scale which goes from 1 to 5 and higher scores mean better outcomes. | From post-intervention (week 13) to follow-up (week 25). |
| To explore indicators of appropriateness. | Appropriateness assessed using Intervention Appropriateness Measure (IAM) scale which goes from 1 to 5 where higher scores mean better outcomes. | From post-intervention (week 13) to follow-up (week 25). |
| To explore indicators of implementation. | Feasibility assessed using the Feasibility of Intervention Measure (FIM) scale which goes from 1 to 5 and higher scores mean better outcomes. | From post-intervention (week 13) to follow-up (week 25). |
| To explore preliminary economic feasibility indicators. | Economic feasibility will be explored through resource-use variables professional time required for support or monitoring, number and type of user support contacts or technical incidents requiring intervention). | From post-intervention (week 13) to follow-up (week 25). |
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided