We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: HOBSCOTCH Phase II: A Pragmatic Study of HOBSCOTCH in New England.
Actual Study Start Date : March 2015
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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.
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.
 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.
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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394509


Locations
Layout table for location information
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, New Hampshire
Dartmouth-Hitchcock Medical Center in Lebanon, NH
Lebanon, New Hampshire, United States, 03766
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Centers for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Barbara C Jobst, MD Dartmouth-Hitchcock Medical Center and Dartmouth College
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Barbara Jobst, Staff Physician, Neurology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02394509    
Other Study ID Numbers: D12217 Phase II
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Keywords provided by Barbara Jobst, Dartmouth-Hitchcock Medical Center:
Epilepsy Memory Problems
Self-Management
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases