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Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy (HOBSCOTCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240977
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Behavioral: HOBSCOTCH: "Home-Based Self-Management and Cognitive Training Changes Lives" Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study utilizes a single-arm pre/post experimental design with an additional 3-month maintenance assessment.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Single-arm Trial of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Treatment Group 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.




Primary Outcome Measures :
  1. Change in Quality of Life in Epilepsy - 31 score [ Time Frame: baseline & 8-10 weeks after baseline ]
    overall raw score [15-97] that corresponds to reported levels of worry, emotional well-being, energy/fatigue, cognitive functioning, medication effects and social functioning


Secondary Outcome Measures :
  1. Feasibility of HOBSCOTCH in the clinical setting [ Time Frame: baseline ]
    Physicians involved (count), referrals made (count), patients contacted and screened (count), patients enrolled (count), patient completing the intervention (count)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240977


Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Erkut Kucukboyaci, Doctoral    973-324-8425    kucukboyaci@kesslerfoundation.org   
Contact: Nancy Chiaravalloti, Doctoral         
Principal Investigator: Erkut Kucukboyaci, PhD         
Sponsors and Collaborators
Kessler Foundation
NYU Langone Health
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT04240977    
Other Study ID Numbers: L -1063-19
90SFGE0010 ( Other Grant/Funding Number: NIDILRR )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual level data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kessler Foundation:
Refractory epilepsy, self-management
Quality of life
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases