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

Cognitive Dysfunction Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391489
• Other study ID #: STUDY 02002402
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Sarah J Kaden, BA
• Phone: 603-540-5824
• Email: sarah.j.kaden[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19
• Memory Dysfunction
• Memory Impairment
• Syndrome

Intervention

Behavioral:
• HOBSCOTCH-PACS
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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-PACS intervention.	The Symbol Digit Modalities Test (SDMT) is a validated tool that measures cognitive processing speed. It requires a person to substitute a number (1 - 9), either orally or written, for randomized presentations of geometric figures over 90 seconds. Scores range between 0 and 100 with a lower score representing poorer performance.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-PACS intervention.	The California Verbal Learning Test-III is a validated verbal learning and memory assessment. It consists of a 16-word, list-recall task with up to five learning/recall trials. Higher scores of recall over time are associated with better performance.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	Change in objective cognition as measured by comparing Montreal Cognitive Assessment (MOCA) scores pre- and post-HOBSCOTCH-PACS intervention.	The Montreal Cognitive Assessment (MOCA) is a validated 30 item test that helps healthcare professionals detect cognitive impairments. The test examines seven domains (aspects) of cognitive function with a total of 11 different exercises and tasks including: executive and visuospatial function, naming, attention, language, abstraction, delayed recall, orientation.; Scores range from 0 - 30 with higher scores indicating less cognitive impairment.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	Change in self-reported autonomic symptoms as measured by comparing COMPASS-31 scores pre- and post-HOBSCOTCH-PACS intervention.	COMPASS 31 is an abbreviated quantitative measure of autonomic symptoms based on the 169-item Autonomic Symptom Profile (ASP) and its validated 84-question scoring instrument, the Composite Autonomic Symptom Score (COMPASS). The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	Change in subjective physical and mental health as measured by comparing PROMIS-29+2 scores pre- and post-HOBSCOTCH-PACS intervention.	PROMIS-29+2 is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It assesses pain intensity and seven health domains: physical functioning, fatigue, pain interference, depression, anxiety, social participation, and sleep disturbance in addition to two (+2) subjective cognition questions. The test is scored on a 5-point Likert scale, except for one question on subjective pain that uses a scale of 1 - 10. The domains are scored separately and compared to a mean score. Scores below 1 SD above the mean do not represent a problem for the person, or perhaps a mild concern. Between 1 and 2 SD reflect a moderate concern or interference in day to day function. Scores worse than 2SD beyond the mean score are considered to reflect poorer subjective physical or mental health.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	Change in participants' self-reports of mood as measured by comparing scores on the PHQ-8 pre- and post-HOBSCOTCH-PACS intervention.	The PHQ-8 is a self-reported, standardized set of 8 questions used to assess the presence and severity of depression symptoms. It is a shortened version of the PHQ-9, omitting the last question about suicidal thoughts or self-harm. The items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores are consistent with greater symptoms of poor mood or depression.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	Change in participants' self-reports of anxiety as measured by comparing scores on the GAD-7 pre- and post-HOBSCOTCH-PACS intervention.	The Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for measuring symptoms of generalized anxiety disorder (GAD). The seven items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores suggest greater symptoms of anxiety.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	Changes in brain fog symptoms as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.	Participants will self-report their brain fog symptoms using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	Changes in autonomic symptom frequency as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.	Participants will self-report their autonomic symptom frequency using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	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.	Participants will self-report their use of the memory strategies they learn in the HOBSCOTCH-PACS program using a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in a paper log.	Recorded daily and compared between baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.
Secondary	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.	Participants will self-report daily well-being information on a single item Likert-scale of well-being throughout the entire study by use of a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in paper log.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	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.	Participants' completed HOBSCOTCH-PACS sessions and smart phone app/daily diary logs will be assessed and recorded weekly. Greater number of sessions and daily diary records indicate better engagement and compliance.	Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
Secondary	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.	The Participant Satisfaction Survey has been developed through the original HOBSCOTH Institute at Dartmouth and is used in clinical practice for program evaluation and quality improvement. It contains 9 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program. Four open-ended questions exist for participants to express likes, dislikes, areas for improvement and additional comments.	After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment.
Secondary	Evaluation of participants' perception of shared-decision making during HOBSCOTCH-PACS intervention as measured by CollaboRATE score.	CollaboRATE is a brief patient survey focused on shared decision making. It employs a 3-item assessment of patient perception of how much effort was made to hear, understand and incorporate their concerns into the program. The items are measured on a 10-point Likert scale in which 0 indicates that no effort was made and 9 indicates every effort was made. Higher scores indicate a greater degree or positive impression of patient perception of shared decision making.	After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment.