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HOBSCOTCH Phase II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02394509
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Barbara Jobst, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE March 6, 2015
First Posted Date  ICMJE March 20, 2015
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE HOBSCOTCH Phase II
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Epilepsy
Intervention  ICMJE 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2018)
106
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2015)
88
Actual Study Completion Date  ICMJE September 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02394509
Other Study ID Numbers  ICMJE D12217 Phase II
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Barbara Jobst, Dartmouth-Hitchcock Medical Center
Original Responsible Party Dartmouth-Hitchcock Medical Center
Current Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Barbara C Jobst, MD Dartmouth-Hitchcock Medical Center and Dartmouth College
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP