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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in overall quality of life as measured by comparing PROMIS-10 Global Health scores pre- and post-HOBSCOTCH-PACS intervention.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Literate, English-speaking with grade 12 or equivalent in education
- •Self-reported diagnosis of PACS
- •Self-reported cognitive/memory difficulties
- •Telephone and internet access
排除标准
- •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
研究组 & 干预措施
PACS Participant With Cognitive and Memory Dysfunction
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)
干预措施: HOBSCOTCH-PACS (Behavioral)
结局指标
主要结局
Change in overall quality of life as measured by comparing PROMIS-10 Global Health scores pre- and post-HOBSCOTCH-PACS intervention.
时间窗: 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.
Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PACS intervention.
时间窗: 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.
次要结局
- 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.(Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.)
- 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 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 participants' self-reports of mood as measured by comparing scores on the PHQ-8 pre- and post-HOBSCOTCH-PACS intervention.(Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.)
- Change in participants' self-reports of anxiety as measured by comparing scores on the GAD-7 pre- and post-HOBSCOTCH-PACS intervention.(Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.)
- 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.(Recorded daily and compared between baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.)
- 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.)
- Evaluation of participants' perception of shared-decision making during HOBSCOTCH-PACS intervention as measured by CollaboRATE score.(After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment.)
- 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.)
- Changes in autonomic symptom frequency as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.(Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.)
- 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.(Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.)
- Changes in brain fog symptoms as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.(Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later.)
- 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.(After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment.)
研究者
Elaine T. Kiriakopoulos
Assistant Professor of Neurology, Geisel School of Medicine at Dartmouth Director, HOBSCOTCH Institute for Cognitive Health & Well-Being Dartmouth Hitchcock Epilepsy Center
Dartmouth-Hitchcock Medical Center