Epilepsy Self-Management for Spanish Speakers: HOBSCOTCH - ESPANOL

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462911
• Other study ID #: STUDY02002468
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Sarah J. Kaden, BA
• Phone: 603-650-4225
• Email: sarah.j.kaden[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Epilepsy
• Memory Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.