HOBSCOTCH for People With Post Acute COVID-19 Syndrome (PACS)

NCT06391489 | Active Not Recruiting

• 1 other identifier: STUDY 02002402
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Acute COVID 19 Syndrome; Memory Impairment; Memory Dysfunction; Cognitive Dysfunction

Keywords

Post Acute COVID 19 Syndrome; Long COVID; Memory; Cognitive Training; Self-Management

Outcome Measures

Primary Outcomes (2)

• Change in overall quality of life as measured by comparing PROMIS-10 Global Health scores pre- and post-HOBSCOTCH-PACS intervention.

  PROMIS Global-10 is a validated 10-question survey and part of the Patient-Reported Outcomes Measurement Information System (PROMIS) used to assess health care-related quality of life. Measures include overall health, pain, fatigue, social health, mental health, and physical health. 9 of the items are scored on a Likert Scale of 1 - 5 with 5 representing the best health care-related quality of life; higher scores are associated with better quality of life. One item related to pain is measured on a scale of 1 - 10 with 10 being the worst possible pain.

  Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.

• Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PACS intervention.

  The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.

  Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.

Secondary Outcomes (14)

• Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-PACS intervention.

  Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.

• Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-PACS intervention.

  Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.

• Change in objective cognition as measured by comparing Montreal Cognitive Assessment (MOCA) scores pre- and post-HOBSCOTCH-PACS intervention.

  Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.

• Change in self-reported autonomic symptoms as measured by comparing COMPASS-31 scores pre- and post-HOBSCOTCH-PACS intervention.

  Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.

• Change in subjective physical and mental health as measured by comparing PROMIS-29+2 scores pre- and post-HOBSCOTCH-PACS intervention.

  Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.

Study Arms (1)

PACS Participant With Cognitive and Memory Dysfunction

OTHER

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)

Behavioral: HOBSCOTCH-PACS

Interventions

HOBSCOTCH-PACS BEHAVIORAL

HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) 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 program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-PD is an adaptation of the HOBSCOTCH program for people with PD and incorporates education about Parkinson Disease and cognition into the education module.

PACS Participant With Cognitive and Memory Dysfunction

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Literate, English-speaking with grade 12 or equivalent in education
• Self-reported diagnosis of PACS
• Self-reported cognitive/memory difficulties
• Telephone and internet access

You may not qualify if:

• Cognitive dysfunction that precludes participation in giving informed consent
• Significant visual impairment precluding reading or writing
• No reliable telephone or internet access
• Neurodegenerative illness (i.e. dementia)
• Acute psychiatric disease

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Memory Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elaine T Kiriakopoulos, MD, MPH, MSc

  Dartmouth-Hitchcock, Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology, Geisel School of Medicine at Dartmouth Director, HOBSCOTCH Institute for Cognitive Health & Well-Being Dartmouth Hitchcock Epilepsy Center

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: May 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)