HOBSCOTCH Phase III
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring Epilepsy Memory Problems, Self-Management
Eligibility Criteria
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
Sites / Locations
- Dartmouth-Hitchcock Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
HOBSCOTCH-V (virtual)
Control
Arm Description
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.
Participants will be wait listed and will receive HOBSCOTCH-V (above) following a 6 month wait period.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04519775
First Posted
August 17, 2020
Last Updated
August 28, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04519775
Brief Title
HOBSCOTCH Phase III
Official Title
HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy Memory Problems, Self-Management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HOBSCOTCH-V (virtual)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Participants will be wait listed and will receive HOBSCOTCH-V (above) following a 6 month wait period.
Intervention Type
Behavioral
Intervention Name(s)
Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
Other Intervention Name(s)
HOBSCOTCH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quality of life
Description
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.
Time Frame
Baseline and at months 3, 6, 9, 12
Title
Change in cognitive function
Description
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.
Time Frame
Baseline and at months 3, 6, 9, 12
Secondary Outcome Measure Information:
Title
Change in depression
Description
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.
Time Frame
Baseline and at months 3, 6, 9, 12
Title
Change in self-management practices
Description
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.
Time Frame
Baseline and at months 3, 6, 9, 12
Title
Changes in self-reported seizure frequency
Description
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.
Time Frame
Ongoing through entire study baseline - 12 months
Title
Changes in medication adherence
Description
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.
Time Frame
Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12
Title
Changes in health confidence
Description
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.
Time Frame
Baseline and at months 3, 6, 9, 12
Title
Changes in healthcare utilization
Description
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.
Time Frame
Baseline and at months 3, 6, 9, 12
Title
Changes in overall well-being
Description
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.
Time Frame
Ongoing through entire study baseline - 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine T Kiriakopoulos, MD, MSc
Phone
603-306-1538
Email
Elaine.T.Kiriakopoulos@dartmouth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne B Lenz, MA, CCRC
Phone
603-650-4225
Email
Suzanne.B.Lenz@hitchcock.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Jobst, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center and Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trina K Dawson, BA
Phone
603-650-8165
Email
trina.k.dawson@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Suzanne Lenz
Phone
603-543-7885
Email
suzanne.b.lenz@htichcock.org
First Name & Middle Initial & Last Name & Degree
Elaine T Kiriakopoulos, MD, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25731132
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.
Results Reference
background
PubMed Identifier
26943948
Citation
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.
Results Reference
background
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HOBSCOTCH Phase III
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