HOBSCOTCH Phase II

• ClinicalTrials.gov Identifier: NCT02394509
• Recruitment Status: Completed
• First Posted: March 20, 2015
• Last Update Posted: August 20, 2020
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Centers for Disease Control and Prevention
• Information provided by (Responsible Party): Barbara Jobst, Dartmouth-Hitchcock Medical Center

Tracking Information

• First Submitted Date: March 6, 2015
• First Posted Date: March 20, 2015
• Last Update Posted Date: August 20, 2020
• Actual Study Start Date: March 2015
• Actual Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2015)

• Change in Quality of Life [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  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
• Change in Healthcare Utilization [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 7, 2016)

• Change in Depression [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  We will be using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale.
• Change in Cognition [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  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.
• Change in Self-Management Practices [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  We will be using the Epilepsy Self-Management Scale (ESMS). This is a 38 item scale that assesses use of epilepsy self-management practices.
• Change in Cognitive Function [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  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.

Original Secondary Outcome Measures (submitted: March 16, 2015)

• Change in Depression [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  We will be using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale.
• Change in Cognition [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  We will be using the Brief Test of Adult Cognition by Telephone (BTACT). This is 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
• Change in Self-Management Practices [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  We will be using the Epilepsy Self-Management Scale (ESMS). This is a 38 item scale that assesses use of epilepsy self-management practices.
• Change in Positive Affect and Well-Being [ Time Frame: Baseline and months: 3, 6, 9, 12, 15 ]
  We will be using the Positive Affect and Well-Being sub-scale of the NeuroQOL. This is a brief validated tool developed by the NIH for use in patients with neurological disease.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HOBSCOTCH Phase II
• Official Title: HOBSCOTCH Phase II: A Pragmatic Study of HOBSCOTCH in New England.
• Brief 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.

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 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: 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.

Study Arms

• Experimental: HOBSCOTCH-IP (in person)
  Participants will receive the HOBSCOTCH intervention consisting of a first session conducted in-person, 3 weekly followed by 3 bi-weekly telephone coaching sessions, and a final session conducted in-person.
  Intervention: Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
• Experimental: HOBSCOTCH-V (virtual)
  Participants will receive the HOBSCOTCH intervention consisting of a first session conducted virtually, 3 weekly followed by 3 bi-weekly telephone coaching sessions, and a final session conducted virtually.
  Intervention: Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
• Control
  Participants will be wait listed and given an option whether they prefer to enroll into HOBSCOTCH-IP or HOBSCOTCH-V. Subjects in Group 3 will receive HOBSCOTCH following a 6 month wait period.
  Intervention: Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)

• Publications *: Streltzov NA, Schmidt SS, Schommer LM, Zhao W, Tosteson TD, Mazanec MT, Kiriakopoulos ET, Chu F, Henninger HL, Nagle K, Roth RM, Jobst B. Effectiveness of a Self-Management Program to Improve Cognition and Quality of Life in Epilepsy: A Pragmatic, Randomized, Multicenter Trial. Neurology. 2022 May 24;98(21):e2174-e2184. doi: 10.1212/WNL.0000000000200346. Epub 2022 Apr 6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2018): 106
• Original Estimated Enrollment (submitted: March 16, 2015): 88
• Actual Study Completion Date: September 2019
• Actual Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02394509
• Other Study ID Numbers: D12217 Phase II
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Barbara Jobst, Dartmouth-Hitchcock Medical Center
• Original Responsible Party: Dartmouth-Hitchcock Medical Center
• Current Study Sponsor: Dartmouth-Hitchcock Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Barbara C Jobst, MD; Dartmouth-Hitchcock Medical Center and Dartmouth College

• PRS Account: Dartmouth-Hitchcock Medical Center
• Verification Date: August 2020