HOBSCOTCH Phase III

Epilepsy Clinical Trial

Official title:

HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04519775
• Other study ID #: D12217 Phase III
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Elaine T Kiriakopoulos, MD, MSc
• Phone: 603-306-1538
• Email: Elaine.T.Kiriakopoulos[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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