HOBSCOTCH Phase III

HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH

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).

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HOBSCOTCH-V (virtual); 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); 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.; Other Names: HOBSCOTCH
Other: Control; 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); 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.; Other Names: HOBSCOTCH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression	The researchers will use the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale. Scores range from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-offs for mild, moderate, moderately severe, and severe depression, respectively.	Baseline and at months 3, 6, 9, 12
Change in self-management practices	The researchers will use the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65).This is a 65 item scale that assesses use of epilepsy self-management practices. Scores range from 65 to 325, with a higher score indicating more frequent use of self-management strategies.	Baseline and at months 3, 6, 9, 12
Changes in self-reported seizure frequency	The researchers will collect seizure information throughout the entire study by use of a smartphone app or paper log to track seizures daily. No range.	Ongoing through entire study baseline - 12 months
Changes in medication adherence	Medication adherence will be collected using the Medication Adherence Rating Scale (MARS), a 10-item inventory to measure medication adherence, as well as by a daily single item medication adherence question through a smartphone app or paper log. For the MARS, scores range from 0 to 10, with a higher score indicating better adherence.	Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12
Changes in health confidence	The researchers will use the Health Confidence Score, a 4-item measure of health confidence. Scores range from 0 to 13, with a higher score indicating better health confidence.	Baseline and at months 3, 6, 9, 12
Changes in healthcare utilization	The researchers will use the Health Care Utilization 4-item measure from the Self-Management Resource Center to capture utilization of health services in the last 6 months. No range.	Baseline and at months 3, 6, 9, 12
Changes in overall well-being	The researchers will collect daily well-being information throughout the entire study by use of a smartphone app or paper log and a basic single item Likert-scale of well-being. No range.	Ongoing through entire study baseline - 12 months

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Barbara Jobst, MD, Dartmouth-Hitchcock Medical Center and Dartmouth College

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Self-Management; Epilepsy Memory Problems
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: D12217 Phase III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No