HOBSCOTCH Phase III

NCT04519775 | Completed

• 1 other identifier: D12217 Phase III
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Epilepsy

Keywords

Epilepsy Memory Problems; Self-Management

Outcome Measures

Primary Outcomes (2)

• Change in quality of life

  The researchers will use the 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. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.

  Baseline and at months 3, 6, 9, 12

• Change in cognitive function

  The researchers will use 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. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.

  Baseline and at months 3, 6, 9, 12

Secondary Outcomes (7)

• Change in depression

  Baseline and at months 3, 6, 9, 12

• Change in self-management practices

  Baseline and at months 3, 6, 9, 12

• Changes in self-reported seizure frequency

  Ongoing through entire study baseline - 12 months

• Changes in medication adherence

  Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12

• Changes in health confidence

  Baseline and at months 3, 6, 9, 12

Study Arms (2)

HOBSCOTCH-V (virtual)

EXPERIMENTAL

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.

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

Control

OTHER

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

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

Interventions

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

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.

Also known as: HOBSCOTCH

Control; HOBSCOTCH-V (virtual)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

• Caller TA, Secore KL, Ferguson RJ, Roth RM, Alexandre FP, Henegan PL, Harrington JJ, Jobst BC. Design and feasibility of a memory intervention with focus on self-management for cognitive impairment in epilepsy. Epilepsy Behav. 2015 Mar;44:192-4. doi: 10.1016/j.yebeh.2014.12.036. Epub 2015 Feb 27.

  PMID: 25731132 BACKGROUND

• Caller TA, Ferguson RJ, Roth RM, Secore KL, Alexandre FP, Zhao W, Tosteson TD, Henegan PL, Birney K, Jobst BC. A cognitive behavioral intervention (HOBSCOTCH) improves quality of life and attention in epilepsy. Epilepsy Behav. 2016 Apr;57(Pt A):111-117. doi: 10.1016/j.yebeh.2016.01.024. Epub 2016 Mar 2.

  PMID: 26943948 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Barbara Jobst, MD

  Dartmouth-Hitchcock Medical Center and Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Neurology

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: November 12, 2020
• Primary Completion: September 26, 2024
• Study Completion: November 19, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)