Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy

NCT04240977 | Unknown

• 2 other identifiers: L -1063-1990SFGE0010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether a phone-intervention called HOBSCOTCH will improve health, daily functioning and quality of life among patients with refractory epilepsy. HOBSCOTCH stands for "Home-Based Self-Management and Cognitive Training Changes Lives." This study will also help to find the best ways of integrating this telehealth intervention to routine clinic use.

Conditions

Refractory Epilepsy

Keywords

Refractory epilepsy, self-management; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life in Epilepsy - 31 score

  overall raw score \[15-97\] that corresponds to reported levels of worry, emotional well-being, energy/fatigue, cognitive functioning, medication effects and social functioning

  baseline & 8-10 weeks after baseline

Secondary Outcomes (1)

• Feasibility of HOBSCOTCH in the clinical setting

  baseline

Study Arms (1)

Treatment Group

EXPERIMENTAL

Behavioral: HOBSCOTCH: "Home-Based Self-Management and Cognitive Training Changes Lives"

Interventions

HOBSCOTCH: "Home-Based Self-Management and Cognitive Training Changes Lives" BEHAVIORAL

Home-Based Self-Management and Cognitive Training Changes Lives (HOBSCOTCH) is a novel phone-based intervention that is enables acquisition of cognitive skills in line with problem solving therapy (PST), and is well suited for PWRE who have failed all other treatment alternatives. Sessions #2 through #7 focus on building patient's awareness for their own day-to-day memory problems, brainstorming, implementing and reviewing the outcomes of potential solutions they generate themselves using the PST framework. In each of these sessions, providers will assist patients in generating alternative solutions, in thinking through what the implementation of each strategy would entail, and in helping them review outcomes for adopted strategies to refine their approach for optimized adoption and generalization.

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Patient is able to read and speak English.
• Patient has a reliable telephone connection and a private place they can use during the course of this study
• They do not have any treatment or intervention plan in place for the next 6 months. They may be on an anti-epileptic drug regimen that has not been changed in the past 3 months.

Sponsors & Collaborators

• Kessler Foundation: lead
• NYU Langone Health: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study utilizes a single-arm pre/post experimental design with an additional 3-month maintenance assessment.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 27, 2020
• Study Start: June 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)