HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - SPANISH/ESPAÑOL
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in subjective cognition as measured by comparing the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on NeuroQOL - Cognitive Function sub-scale.
Study Overview
Brief Summary
The goal of this pilot study is to assess the feasibility of translating and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with epilepsy whose primary language is Spanish.
The main questions it aims to answer are:
- Can the current HOBSCOTCH program be successfully translated for Spanish speaking people with epilepsy?
- Will people with epilepsy who speak Spanish experience improved quality of life similar to that found in people with epilepsy who received the HOBSCOTCH program in English?
Participants will be asked to:
- attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-SPANISH sessions with a one-on-one certified bilingual HOBSCOTCH coach
- complete a brief clinical questionnaire about their diagnosis of epilepsy
- complete two questionnaires before and after the HOBSCOTCH sessions about their quality of life and about memory and thinking processes
- keep a short daily diary about their seizures, symptoms and use of the self-management strategies taught in the HOBSCOTCH program
- complete a brief Satisfaction Survey and a 3 question survey about shared decision making after the entire HOBSCOTCH program
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (18 + years)
- •Self-reported epilepsy with controlled or uncontrolled seizures
- •Spanish as primary language
- •Literate in Spanish (per bilingual Cognitive Coach)
- •Access to the internet and/or a telephone
Exclusion Criteria
- •Self-report of a dementing illness, a dementing illness appearing in their medical record if available or in the judgment of the Principal Investigator or Bilingual Coach
- •Severe mental disability or estimated IQ less than 70 per clinical judgement of the Principal Investigator or Bilingual Coach
- •Significant visual impairment precluding reading or writing
- •No reliable telephone or internet access
- •No self-reported diagnosis of epilepsy
Arms & Interventions
Spanish speaking participant with self-reported epilepsy and cognitive and memory dysfunction
Participants will receive the HOBSCOTCH intervention (in Spanish) 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)
Intervention: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) - Spanish/Espanol (Behavioral)
Outcomes
Primary Outcomes
Change in subjective cognition as measured by comparing the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on NeuroQOL - Cognitive Function sub-scale.
Time Frame: Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
The Cognitive Function sub-scale of the NeuroQOL 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.
Change in quality of life as measured by comparing the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on the Quality of Life in Epilepsy-10 (QOLIE-10).
Time Frame: Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
The QOLIE-10 is a standard, brief questionnaire that asks people with epilepsy about the impact of their condition on their lives. It consists of 10 questions based on a 5-point Likert scale ranging from "none of the time or not at all" to "all of the time or extremely." The scoring ensures that positive responses are represented by lower numbers, while negative responses correspond to higher numbers. The total score is calculated by summing the scores for all answered questions and dividing by the number of items answered. Patients with lower scores experience fewer problems related to their epilepsy.
Secondary Outcomes
- Evaluation of participants' perception of shared-decision making during HOBSCOTCH-Spanish/Espanol intervention as measured by CollaboRATE score.(After the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.)
- Participant satisfaction with the HOBSCOTCH-Spanish/Espanol program as measured by analyzing a Participant Satisfaction Survey at the end of the study.(After the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.)
Investigators
Elaine T. Kiriakopoulos
Elaine T. Kiriakopoulos, MD, MPH, MSc 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