Epilepsy Self-Management for Spanish Speakers: HOBSCOTCH - ESPANOL

NCT06462911 | Withdrawn

• 1 other identifier: STUDY02002468
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Epilepsy; Cognitive Dysfunction; Memory Disorders

Keywords

Epilepsy; Memory; Cognitive training; Self management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (1)

Spanish speaking participant with self-reported epilepsy and cognitive and memory dysfunction

EXPERIMENTAL

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

Interventions

HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) - Spanish/Espanol BEHAVIORAL

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.

Also known as: HOBSCOTCH-Spanish/Espanol

Spanish speaking participant with self-reported epilepsy and cognitive and memory dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Epilepsy; Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine T Kiriakopoulos, MD, MPH, MSc

  Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 17, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

US (1)