Clinical trial NCT06462911: Epilepsy Self-Management for Spanish Speakers: HOBSCOTCH - ESPANOL
Official title: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - SPANISH/ESPAÑOL
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Cognitive Dysfunction
Memory Disorders
Keywords: Epilepsy
Memory
Cognitive training
Self management
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 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:

1. Can the current HOBSCOTCH program be successfully translated for Spanish speaking people with epilepsy?
2. 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


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
measure: Change in subjective cognition as measured by comparing the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on NeuroQOL - Cognitive Function sub-scale.
timeFrame: Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
Secondary outcomes:
measure: Participant satisfaction with the HOBSCOTCH-Spanish/Espanol program as measured by analyzing a Participant Satisfaction Survey at the end of the study.
timeFrame: After the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.
measure: Evaluation of participants' perception of shared-decision making during HOBSCOTCH-Spanish/Espanol intervention as measured by CollaboRATE score.
timeFrame: After the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College
name: Elaine T Kiriakopoulos, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References: