Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy

Refractory Epilepsy Clinical Trial

— HOBSCOTCH  

Official title:

Feasibility and Single-arm Trial of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240977
• Other study ID #: L -1063-19
• Secondary ID: 90SFGE0010
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2021
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of HOBSCOTCH in the clinical setting	Physicians involved (count), referrals made (count), patients contacted and screened (count), patients enrolled (count), patient completing the intervention (count)	baseline