Epilepsy Self-Management for Spanish Speakers: HOBSCOTCH - ESPANOL

HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - SPANISH/ESPAÑOL

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

Study Overview

• Status: Withdrawn
• Conditions: Epilepsy; Cognitive Dysfunction; Memory Disorders
• Intervention / Treatment: Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) - Spanish/Espanol

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Contact: Sarah J Kaden, BA; Phone Number: 603-650-4225; Email: sarah.j.kaden@hitchcock.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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)

Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) - Spanish/Espanol; 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. The entire HOBSCOTCH program has been translated into Spanish for people with epilepsy who speak Spanish.; Other Names: HOBSCOTCH-Spanish/Espanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
Change in subjective cognition as measured by comparing the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on NeuroQOL - Cognitive Function sub-scale.	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.	Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction with the HOBSCOTCH-Spanish/Espanol program 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 program and is used in clinical practice for quality improvement and was translated into Spanish. It contains 10 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program.	After the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.
Evaluation of participants' perception of shared-decision making during HOBSCOTCH-Spanish/Espanol 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 the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Elaine T Kiriakopoulos, MD, MPH, MSc, Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Epilepsy; Memory; Cognitive training; Self management
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Epilepsy; Cognitive Dysfunction; Memory Disorders
• Other Study ID Numbers: STUDY02002468

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No