HOBSCOTCH for Post-COVID Syndrome

Overseen By Elaine T Kiriakopoulos, MD, MPH, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Dementia, Acute psychiatric disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on self-management strategies rather than medication changes.

What data supports the effectiveness of the treatment HOBSCOTCH-PACS for Post-COVID Syndrome?

A study found that a personalized computerized cognitive training (CCT) program improved cognitive function in people with post-acute sequelae of COVID-19 (PASC). Participants showed significant improvements in attention, memory, and reasoning after using the CCT application at home for eight weeks. ^{1 2 3 4 5}

Is the HOBSCOTCH treatment for Post-COVID Syndrome safe for humans?

The available research does not provide specific safety data for the HOBSCOTCH treatment, but it involves a self-administered computerized cognitive training, which is generally considered safe as it is non-invasive and conducted at home. ^{1 2 6 7 8}

How is the HOBSCOTCH-PACS treatment different from other treatments for post-COVID syndrome?

HOBSCOTCH-PACS is unique because it is a home-based, self-administered cognitive training program that uses personalized computerized tasks to improve cognitive function in people with post-COVID syndrome. Unlike other treatments, it focuses on enhancing cognitive abilities through gamified exercises that can be done at home, offering a flexible and accessible option for patients. ^{1 2 6 9 10}

What is the purpose of this trial?

The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Post Acute Covid Syndrome (PACS). The main questions it aims to answer are: Can the current HOBSCOTCH program be adapted for people with PACS? Will people with PACS experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program? Participants will be asked to: * attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PACS sessions with a one-on-one certified HOBSCOTCH-PACS coach * complete a brief clinical questionnaire about their diagnosis of PACS * complete seven questionnaires before and after the HOBSCOTCH-PACS sessions about their quality of life, memory and thinking processes (objective and subjective cognition), about their physical and mental health and about autonomic symptoms associated with their diagnosis of PACS * keep a short daily diary (using a smart phone app or on paper) about their PACS symptoms and use of the self-management strategies taught in the HOBSCOTCH-PACS program * complete two brief surveys to assess satisfaction with their experience after the entire HOBSCOTCH-PACS program

Research Team

Elaine T Kiriakopoulos, MD, MSc

Principal Investigator

Dartmouth-Hitchcock, Dartmouth College

Eligibility Criteria

This trial is for English-speaking individuals with at least a grade 12 education level who have post-acute COVID-19 syndrome (PACS) and self-reported memory or cognitive issues. They must have telephone and internet access to participate in virtual sessions.

Inclusion Criteria

I experience problems with my memory or thinking.

I have access to a telephone and the internet.

I have been diagnosed with PACS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-HOBSCOTCH Session

Participants complete a pre-HOBSCOTCH session to prepare for the intervention

1 week

1 visit (virtual)

HOBSCOTCH-PACS Intervention

Participants attend nine, one-hour virtual HOBSCOTCH-PACS sessions with a certified coach

9 weeks

9 visits (virtual)

Follow-up

Participants are monitored for changes in quality of life, cognition, and other health metrics

4 weeks

Treatment Details

Interventions

• HOBSCOTCH-PACS

Trial Overview The study tests if the HOBSCOTCH program, originally for epilepsy self-management, can help improve quality of life for people with PACS. It involves nine one-hour online sessions with a coach, questionnaires on health and cognition, daily symptom diaries, and satisfaction surveys.

Participant Groups

Group I: PACS Participant With Cognitive and Memory Dysfunction Experimental Treatment 1 Intervention

Participants will receive the HOBSCOTCH-PACS intervention consisting of 1:1 sessions delivered once per week including: 1 pre-HOBSCOTCH Session (on webcam or by phone) 1 educational session (on webcam) 6 HOBSCOTCH intervention sessions (webcam or phone) 1 wrap-up session (webcam or phone)

HOBSCOTCH-PACS is already approved in United States for the following indications:

Approved in United States as HOBSCOTCH for:

• Epilepsy
• Post-Acute COVID-19 Syndrome (PACS)

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Findings from Research

A pilot study involving 73 adults with cognitive dysfunction post-COVID-19 showed that an 8-week personalized computerized cognitive training (CCT) significantly improved cognitive function across multiple domains, including attention, memory, and reasoning.

Participants reported higher cognitive scores after the training compared to their baseline assessments, indicating that self-administered CCT could be an effective intervention for alleviating cognitive issues in individuals suffering from post-acute sequelae of COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Computerized Training for Cognitive Dysfunction after COVID-19: A Before-and-After Feasibility Pilot Study. Duñabeitia, JA., Mera, F., Baro, Ó., et al.[2023]

This study evaluates a comprehensive treatment program for post-acute COVID-19 syndrome (PACS) involving online screening and personalized support, aiming to improve diagnosis and recovery for patients.

Participants will be divided into groups receiving different levels of assessment and digital interventions, with the primary focus on symptom reduction and return to work, making it one of the first large-scale efforts to address PACS effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and assessment for post-acute COVID-19 syndrome (PACS), guidance by personal pilots and support with individual digital trainings within intersectoral care: a study protocol of a randomized controlled trial. Dahmen, A., Keller, FM., Derksen, C., et al.[2022]

A neuropsychological rehabilitation program for post-COVID-19 syndrome significantly improved cognitive functions such as working memory and verbal fluency in 123 patients, with 74% experiencing cognitive impairment before treatment.

Despite these improvements, many patients (44.9%) were still unable to return to their pre-COVID-19 work activities six months after treatment, indicating that full recovery of functional levels may not be achieved for all.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neuropsychological rehabilitation for post-COVID-19 syndrome: Results of a clinical program and six-month follow up.] García-Molina, A., García-Carmona, S., Espiña-Bou, M., et al.[2023]

A neuropsychological rehabilitation program for post-COVID-19 syndrome significantly improved cognitive functions such as working memory and verbal fluency in 91 patients with cognitive impairment, highlighting its efficacy in addressing cognitive-emotional deficits.

Despite these improvements, a follow-up six months later revealed that nearly 45% of patients were still unable to return to their pre-COVID-19 work activities, indicating that full recovery of functional levels may not be achieved for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological rehabilitation for post-COVID-19 syndrome: results of a clinical programme and six-month follow up. García-Molina, A., García-Carmona, S., Espiña-Bou, M., et al.[2023]

The LISTEN project aims to co-design personalized self-management resources for individuals with long Covid, involving 30 participants with lived experience and 15 rehabilitation practitioners to ensure the intervention meets diverse needs.

This innovative approach, which will be evaluated in a randomized controlled trial, seeks to provide effective support for those not hospitalized due to Covid, potentially improving their quality of life and being made available through the UK's National Health Service if proven effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-designing personalised self-management support for people living with long Covid: The LISTEN protocol. Heaton-Shrestha, C., Torrens-Burton, A., Leggat, F., et al.[2022]

The Victorian Post-Acute COVID-19 Study (VPACS) emphasizes the need for establishing patient registries and data linkage to better understand and manage long COVID, involving collaboration among clinicians, researchers, and patients.

Future research should focus on large, multicenter studies to explore the effects of vaccination, variant impacts, and the biological mechanisms of long COVID, ensuring that patient experiences inform care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-acute COVID-19 condition (PACC): a perspective on collaborative Australian research imperatives and primary health models of care. Tippett, E., Hitch, D., Irving, L., et al.[2023]

The COVIDCare@Home program successfully conducted 3412 virtual visits for 616 patients in its first 8 months, demonstrating its feasibility and effectiveness in providing remote care during the acute phase of COVID-19.

The program showed a high patient satisfaction score (net promoter score of 77) and effectively reached marginalized populations, indicating its potential for addressing both health care needs and social determinants of health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of COVIDCare@Home, a Family Medicine-Led Remote Monitoring Program for Patients With COVID-19: Multimethod Cross-sectional Study. Laur, C., Agarwal, P., Thai, K., et al.[2022]

In a study of 28,048 COVID-19 patients in Mexico, those who received a treatment kit and telephone follow-up had a significantly lower hospitalization rate (6.14%) compared to those who did not receive these interventions (11.71%).

Receiving a medical kit was associated with a 59% reduction in the risk of hospitalization or death from COVID-19, indicating that such multimodal strategies can effectively improve outcomes for patients with mild cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multimodal Strategy to Reduce the Risk of Hospitalization/death in Ambulatory Patients with COVID-19. Ascencio-Montiel, IJ., Tomás-López, JC., Álvarez-Medina, V., et al.[2022]

A new integrated rehabilitation pathway for post COVID-19 syndrome was developed in the UK, addressing persistent symptoms experienced by both hospitalized and non-hospitalized patients, and aligning with NHS England's plan for assessment clinics.

This pathway features a three-tier service model that includes a specialist multidisciplinary team (MDT), community therapy teams, and self-management support, aiming to provide comprehensive and individualized care for patients suffering from Long COVID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multidisciplinary NHS COVID-19 Service to Manage Post-COVID-19 Syndrome in the Community. Parkin, A., Davison, J., Tarrant, R., et al.[2022]

A community-based Long Covid support service combining psycho-educational and mind-body approaches showed positive outcomes, with participants reporting improvements in mental, physical, emotional, and spiritual wellbeing as measured by the Warwick Holistic Health Questionnaire.

Out of 25 participants, 16 showed significant improvement in their wellbeing scores after engaging with the service, indicating that this complementary approach is beneficial for individuals experiencing health challenges from Long Covid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A service evaluation of a community project combining psychoeducation and mind-body complementary approaches to support those with long covid in the UK. Brough, DN., Abel, S., Priddle, L.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Computerized Training for Cognitive Dysfunction after COVID-19: A Before-and-After Feasibility Pilot Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Screening and assessment for post-acute COVID-19 syndrome (PACS), guidance by personal pilots and support with individual digital trainings within intersectoral care: a study protocol of a randomized controlled trial. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

[Neuropsychological rehabilitation for post-COVID-19 syndrome: Results of a clinical program and six-month follow up.] [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

Neuropsychological rehabilitation for post-COVID-19 syndrome: results of a clinical programme and six-month follow up. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Co-designing personalised self-management support for people living with long Covid: The LISTEN protocol. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Post-acute COVID-19 condition (PACC): a perspective on collaborative Australian research imperatives and primary health models of care. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of COVIDCare@Home, a Family Medicine-Led Remote Monitoring Program for Patients With COVID-19: Multimethod Cross-sectional Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Multimodal Strategy to Reduce the Risk of Hospitalization/death in Ambulatory Patients with COVID-19. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Multidisciplinary NHS COVID-19 Service to Manage Post-COVID-19 Syndrome in the Community. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A service evaluation of a community project combining psychoeducation and mind-body complementary approaches to support those with long covid in the UK. [2023]