HOBSCOTCH Phase III

Dartmouth Health

Status: Completed

Conditions: Epilepsy

Treatments: Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04519775

D12217 Phase III

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH." It will test whether HOBSCOTCH can be delivered nationally from a distance utilizing e-health tools (telephone, computer, and phone).

Full 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 III is a study to examine an entirely virtual version of the program. While HOBSCOTCH was shown to be effective as an in-person and telephone-based program in previous trials (HOBSCOTCH Phase I and II), this study aims to test a version of the program adapted for entirely virtual delivery. This is a single-center study, with the HOBSCOTCH intervention being delivered by staff affiliated with Dartmouth-Hitchcock Medical Center in Lebanon, NH.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18+
• 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
• Internet access

Exclusion criteria

• Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record
• Severe mental disability or estimated IQ less than 70 per clinical judgement
• Significant visual impairment precluding reading or writing
• No reliable telephone or internet access
• No diagnosis of epilepsy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

HOBSCOTCH-V (virtual)

Experimental group

Description:

Participants will receive the HOBSCOTCH intervention consisting of 1:1 sessions delivered once per week, including: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions * 1 wrap-up session (webcam or telephone) Participants will also receive 3 booster sessions, via webcam or telephone, once per month.

Treatment:

Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)

Control

Other group

Description:

Participants will be wait listed and will receive HOBSCOTCH-V (above) following a 6 month wait period.

Treatment:

Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)