Clinical trial NCT06391489: HOBSCOTCH for People With Post Acute COVID-19 Syndrome (PACS)
Official title: Piloting A Telehealth Deliverable Self-Management and Cognitive Training Program (HOBSCOTCH, HOme Based Self-Management and COgnitive Training CHanges Lives) for People With Post Acute COVID-19 Syndrome (PACS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in overall quality of life as measured by comparing PROMIS-10 Global Health scores pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary outcomes:
measure: Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Change in objective cognition as measured by comparing Montreal Cognitive Assessment (MOCA) scores pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Change in self-reported autonomic symptoms as measured by comparing COMPASS-31 scores pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Change in subjective physical and mental health as measured by comparing PROMIS-29+2 scores pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Change in participants' self-reports of mood as measured by comparing scores on the PHQ-8 pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Change in participants' self-reports of anxiety as measured by comparing scores on the GAD-7 pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Changes in brain fog symptoms as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Changes in autonomic symptom frequency as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Changes in participants' use of memory strategies as measured by a daily self-reported diary compared at baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.
timeFrame: Recorded daily and compared between baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.
measure: Changes in participants' self-reports of wellbeing as measured by comparing daily reports of well-being at baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Evaluation of participants' engagement and compliance in HOBSCOTCH-PACS by measuring completed HOBSCOTCH sessions and use of smart phone app/daily diary from baseline (pre-HOBSCOTCH-PACS) through post-HOBSCOTCH-PACS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
measure: Evaluation of participant satisfaction with the HOBSCOTCH-PACS intervention as measured by Satisfaction for PTE Participants as measured by analyzing a Participant Satisfaction Survey at the end of the study.
timeFrame: After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment.
measure: Evaluation of participants' perception of shared-decision making during HOBSCOTCH-PACS intervention as measured by CollaboRATE score.
timeFrame: After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock, Dartmouth College
name: Elaine T Kiriakopoulos, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References: