Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756, United States
NCT Number: NCT06391489
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
This study is active but is not currently recruiting participants.
Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Lebanon, New Hampshire, 03756, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Recorded daily and compared between 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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.
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.
Time frame: After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment.
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.
Time frame: After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment.
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.
Dartmouth-Hitchcock Medical Center
Other
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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