HOBSCOTCH Phase II

Epilepsy Clinical Trial

Official title:

HOBSCOTCH Phase II: A Pragmatic Study of HOBSCOTCH in New England.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394509
• Other study ID #: D12217 Phase II
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 2019

Study information

• Verified date: August 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the feasibility and efficacy of the home-based cognitive self-management program "HOBSCOTCH" delivered at four New England medical centers. It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be delivered from a distance utilizing e-health tools for parts of the program.

Description:

HOBSCOTCH (Home Based Self-management and Cognitive Training Changes lives) is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life.

HOBSCOTCH Phase II is a replication study of the original HOBSCOTCH study, designed to translate the findings of HOBSCOTCH into a real world setting. This is a multi-center study, with the HOBSCOTCH intervention being implemented at four epilepsy clinics in New England.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70

• Confirmed diagnosis of epilepsy, with controlled or uncontrolled seizures

• Subjective memory complaints

• No changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable

• Literate

• Telephone access

Exclusion Criteria:

• Subjects age 66-70 with a mention of a dementing illness in their medical record

• Severe mental disability or estimated IQ less than 70

• Significant visual impairment precluding reading or writing

• No reliable telephone access

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life.

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Dartmouth-Hitchcock Medical Center in Lebanon, NH	Lebanon	New Hampshire
United States	Maine Medical Center	Portland	Maine
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life	We will be using Quality of Life in Epilepsy (QOLIE-31). This validated tool contains 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception	Baseline and months: 3, 6, 9, 12, 15
Primary	Change in Healthcare Utilization	We will be using the Healthcare Utilization in Epilepsy (HCU-E). This validated survey is concordant with billing data. It assesses seizure frequency and whether the subject had received any of the following services because of their epilepsy over the past 3 months: hospital ER services, general practice or family doctor visits, neurologist or epilepsy specialist visits, and overnight hospital inpatient stay.	Baseline and months: 3, 6, 9, 12, 15
Secondary	Change in Depression	We will be using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale.	Baseline and months: 3, 6, 9, 12, 15
Secondary	Change in Cognition	We will be using a modified version of the Brief Test of Adult Cognition by Telephone (BTACT). This is a modified version of a validated psychometric instrument that can be delivered over the phone in 20 minutes. It includes measures of episodic memory, working memory, reasoning, verbal fluency and executive function.	Baseline and months: 3, 6, 9, 12, 15
Secondary	Change in Self-Management Practices	We will be using the Epilepsy Self-Management Scale (ESMS). This is a 38 item scale that assesses use of epilepsy self-management practices.	Baseline and months: 3, 6, 9, 12, 15
Secondary	Change in Cognitive Function	We will be using the Cognitive Function sub-scale of the NeuroQOL. This is a brief validated tool developed by the NIH for use in patients with neurological disease.	Baseline and months: 3, 6, 9, 12, 15