Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy (HOBSCOTCH)
Primary Purpose
Refractory Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HOBSCOTCH: "Home-Based Self-Management and Cognitive Training Changes Lives"
Sponsored by
About this trial
This is an interventional supportive care trial for Refractory Epilepsy focused on measuring Refractory epilepsy, self-management, Quality of life
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.
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04240977
First Posted
December 17, 2019
Last Updated
February 3, 2021
Sponsor
Kessler Foundation
Collaborators
NYU Langone Health
1. Study Identification
Unique Protocol Identification Number
NCT04240977
Brief Title
Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy
Acronym
HOBSCOTCH
Official Title
Feasibility and Single-arm Trial of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy
Keywords
Refractory epilepsy, self-management, Quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study utilizes a single-arm pre/post experimental design with an additional 3-month maintenance assessment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
HOBSCOTCH: "Home-Based Self-Management and Cognitive Training Changes Lives"
Intervention Description
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 Measure Information:
Title
Change in Quality of Life in Epilepsy - 31 score
Description
overall raw score [15-97] that corresponds to reported levels of worry, emotional well-being, energy/fatigue, cognitive functioning, medication effects and social functioning
Time Frame
baseline & 8-10 weeks after baseline
Secondary Outcome Measure Information:
Title
Feasibility of HOBSCOTCH in the clinical setting
Description
Physicians involved (count), referrals made (count), patients contacted and screened (count), patients enrolled (count), patient completing the intervention (count)
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erkut Kucukboyaci, Doctoral
Phone
973-324-8391
Email
ekucukboyaci@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nancy Moore, Masters
Phone
9733248450
First Name & Middle Initial & Last Name & Degree
Erkut Kucukboyaci, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual level data will be shared.
Learn more about this trial
Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy
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