Randomized Controlled Trial to Assess the Efficacy of a Supervised Computerized Active Program (SuperCAP) to Improve Cognition and Daily Functioning in People With Post-COVID-19 Condition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To determine whether the SuperCAP intervention program is superior to control in reducing disability.
研究概览
简要总结
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.
详细描述
-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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PCC, defined as the presence of three or more symptoms associated with COVID-19 infection for at least three months, not explained by other diseases.
- •Age 18 to 65 years.
- •Willingness to participate in an app-based intervention program aimed at improving daily Functioning in People Living with PCC.
- •Evidence of patient-reported cognitive difficulties emerging after COVID-19, operationalized as a WHODAS 2.0 Cognition Domain (D1) score > 6 at baseline via RedCAP.
- •Digital proficiency defined as scoring ≥4 on MDPQ-16 item 2a (sending emails) and ≥3 on item 6a (using the device's app store) via RedCAP.
- •Self-reported ability to use a mobile application for approximately 15 minutes per day, 5 days per week, considering their current symptoms.
- •Possession of a personal smartphone compatible with the study mobile application (eSalut), with sufficient storage space and operating system version required for installation.
排除标准
- •Inability to undergo neuropsychological tests or additional assessments.
- •Prior use of the SuperCAP program.
- •Current participation in a trial or program aimed at improving PCC symptoms.
- •Any condition that, in the investigator's opinion, could make participation unsafe, complicate interpretation of study results, interfere with achievement of study objectives, or otherwise affect the participant's ability to complete the study.
研究组 & 干预措施
SuperCAP Arm
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.
干预措施: SuperCAP intervention program (Device)
Standard of Care Arm
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.
干预措施: Psychoeducational intervention (Other)
结局指标
主要结局
To determine whether the SuperCAP intervention program is superior to control in reducing disability.
时间窗: From baseline (week 0) to the post-intervention assessment (week 13).
Change in total WHODAS 2.0 score from baseline to post-intervention.
次要结局
- To assess whether the SuperCAP intervention leads to greater improvements in quality of life compared with control.(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.(From baseline (week 0) to post-intervention (week 13).)
- To evaluate whether the intervention improves performance-based cognitive measures.(From baseline (week 0) to post-intervention (week 13).)
- To evaluate whether the intervention improves patient-reported cognitive functioning.(From baseline (week 0) to post-intervention (week 13).)
- To assess reductions in depressive symptoms following the intervention.(From baseline (week 0) to post-intervention (week 13))
- To assess reductions in anxiety symptoms following the intervention.(From baseline (week 0) to post-intervention (week 13).)
- To determine whether improvements in functional outcomes are sustained at follow-up.(From post-intervention (week 13) to follow-up (week 25).)
- To determine whether improvements in cognitive outcomes are sustained at follow-up.(From post-intervention (week 13) to follow-up (week 25).)
- To determine whether improvements in emotional outcomes are sustained at follow-up.(From post-intervention (week 13) to follow-up (week 25).)
- To evaluate feasibility of implementation, including adherence to the program.(From post-intervention (week 13) to follow-up (week 25))
- To evaluate feasibility of implementation, including usability.(From post-intervention (week 13) to follow-up (week 25))
- To evaluate feasibility of implementation, including satisfaction and retention.(From post-intervention (week 13) to follow-up (week 25).)
- To explore indicators of acceptability.(From post-intervention (week 13) to follow-up (week 25).)
- To explore indicators of appropriateness.(From post-intervention (week 13) to follow-up (week 25).)
- To explore indicators of implementation.(From post-intervention (week 13) to follow-up (week 25).)
- To explore preliminary economic feasibility indicators.(From post-intervention (week 13) to follow-up (week 25).)