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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a program originally designed for managing epilepsy can improve the quality of life for people with Post Acute COVID Syndrome (PACS). The program, called HOBSCOTCH-PACS, includes virtual sessions with a coach to teach self-management strategies. The goal is to determine if it can help with memory and thinking issues related to PACS. Participants will complete questionnaires and maintain a daily diary about their symptoms and progress. This trial suits English-speaking individuals with PACS who experience cognitive or memory difficulties and have access to a phone and the internet. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance the quality of life for those with PACS.

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 prior data suggests that the HOBSCOTCH program is safe for people with Post Acute Covid Syndrome?

Research has shown that the HOBSCOTCH program, initially developed for epilepsy, is safe and user-friendly. Studies have found it improves quality of life and mental abilities without causing harm. Participants can complete the program at home and manage it independently, making it accessible and low-risk. Past studies reported no serious side effects. Participants often experience emotional improvement and increased confidence in managing their condition. Because HOBSCOTCH is non-invasive and centers on mental exercises, it is considered safe for new conditions like Post Acute Covid Syndrome (PACS). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HOBSCOTCH-PACS treatment for Post-COVID Syndrome because it offers a personalized and accessible approach to managing cognitive and memory dysfunction, which is a common issue in this condition. Unlike standard treatments that might rely heavily on medication or more generalized cognitive therapies, HOBSCOTCH-PACS involves one-on-one sessions that are tailored to each participant's unique challenges. This intervention includes a mix of educational and practical sessions conducted via webcam or phone, making it convenient and adaptable to individual needs. By focusing on personalized cognitive rehabilitation techniques, this treatment has the potential to improve quality of life for those struggling with lingering cognitive effects of COVID-19.

What evidence suggests that the HOBSCOTCH program is effective for Post Acute Covid Syndrome?

Research has shown that HOBSCOTCH, a home-based self-management program, benefits people with epilepsy. Studies have found it improves thinking skills and quality of life by reducing obstacles to care. Although initially designed for epilepsy, early results suggest that similar programs have benefited people with long COVID by enhancing emotional well-being, reducing fatigue, and boosting confidence in managing their condition. While specific data for Post Acute COVID Syndrome (PACS) remains limited, these findings encourage adapting the program to support those with PACS. Participants in this trial will receive the HOBSCOTCH-PACS intervention, which includes personalized sessions to address cognitive and memory dysfunction associated with PACS. ^{1 2 3 4 6}

Who Is on the Research Team?

Elaine T Kiriakopoulos, MD, MSc

Principal Investigator

Dartmouth-Hitchcock, Dartmouth College

Are You a Good Fit for This Trial?

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 have access to a telephone and the internet.

I experience problems with my memory or thinking.

I have been diagnosed with PACS.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9169940/

Effectiveness of a Self-Management Program to Improve ... We conducted a multisite, pragmatic replication trial at 4 New England epilepsy centers to determine the effectiveness of Home-Based Self-Management and ...

2. reaganudall.org reaganudall.org/clinical-trial/hobscotch-people-post-acute-covid-19-syndrome-pacs

HOBSCOTCH for People With Post Acute COVID-19 ... HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care.

3. withpower.com withpower.com/trial/phase-syndrome-4-2024-43057

HOBSCOTCH for Post-COVID Syndrome The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11881025/

Effectiveness of a personalised self-management intervention ... Improvements in emotional wellbeing, fatigue, quality of life, and self-efficacy for people living with long covid were also reported. Physical health and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04519775

Study Details | NCT04519775 | HOBSCOTCH Phase III The purpose of this study is to determine the efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02394509

Study Details | NCT02394509 | HOBSCOTCH Phase II HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The ...