Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy

NCT ID: NCT04240977

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-06-30

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.

Detailed Description

The proposed project will assess the efficacy of an 8-week phone-delivered, experimental treatment called "Home-Based Self-Management and Cognitive Training Changes Lives" (HOBSCOTCH) on sixty patients with refractory epilepsy (PWRE). The investigators will employ a prospective, single blind randomized clinical trial design with wait-list controls to examine both objective and subjective measures of daily life, daily functioning, cognition, and emotional well-being. Investigators will also assess the impact of HOBSCOTCH on employment and work productivity using the Lam Employment absence and Disability Scale (LEAPS) and the Sheehan Disability Scale (SDS). Lastly, the investigators will examine whether changes in these domains are maintained three months after completion of the intervention. The study will expand the efficacy literature for HOBSCOTCH and further refine its use in a busy clinical environment, and therefore has potential to benefit the patient population (PWRE), who currently lacks treatment options besides the pharmacological and surgical care currently available.

Conditions

Refractory Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment Group

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Erkut Kucukboyaci, Doctoral

Role: primary

ekucukboyaci@kesslerfoundation.org

973-324-8391

Nancy Moore, Masters

Role: backup

9733248450

Other Identifiers

90SFGE0010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

L -1063-19

Identifier Type: -

Identifier Source: org_study_id