A Pragmatic Trial of HOBSCOTCH in Georgia

NCT04639206 | Completed

• 2 other identifiers: STUDY00000913CDC-STUDY00000913
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to answer the question: Will a home-based self-management program, HOBSCOTCH, be effective in improving quality of life and perceived difficulties in cognitive abilities by teaching problem-solving strategies? The research team is also looking at a new mobile application that was developed to go with the program, and looking at extra booster sessions to improve long-term outcomes. In order to learn about the effectiveness of the program, half of the people in this study will be randomly assigned to be in the intervention immediately. The other half will be randomly assigned to a 6-month waitlist period before getting the intervention. All participants will receive the program at some point during the study.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Life in Epilepsy (QOLIE-31) Score

  Efficacy of the HOBSCOTCH intervention will be assessed with the QOLIE-31 instrument. The QOLIE includes 31 questions about health and daily activities. Responses are given on a range of scales. Responses are coded to 0 to 100 point scales where higher scores indicate better quality of life. The final score is the average of scores for the individual items. Final scores can be converted to a T-score with a mean of 50 and standard deviation of 10, where higher T-scores indicate better quality of life.

  Baseline, Months 3, 6, 9, 12

• Change in Neuro Quality of Life (Neuro-QOL) Item Bank v2.0 - Cognitive Function Score

  Efficacy of the HOBSCOTCH intervention will be assessed with the Neuro-QOL instrument.The Neuro-QOL - Cognitive Function questionnaire includes 28 items asking about how much difficulty they are experiencing and how often they have had trouble with certain tasks during the past 7 days. Responses are given on a scale from 1 to 5 where 1 = cannot do/very often and 5 = none/never. Total scores range from 28 to 140 and higher scores indicate improved cognitive function.

  Baseline, Months 3, 6, 9, 12

Secondary Outcomes (7)

• Change in Patient Health Questionnaire - 9 Depression (PHQ-9) Score

  Baseline, Months 3, 6, 9, 12

• Change in Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65) Score

  Baseline, Months 3, 6, 9, 12

• Seizure Frequency

  Baseline to Month 12

• Change in Medication Adherence Rating Scale (MARS) Score

  Baseline, Months 3, 6, 9, 12

• Change in Health Confidence Score (HCS)

  Baseline, Months 3, 6, 9, 12

Study Arms (2)

HOBSCOTCH group

EXPERIMENTAL

Participants in this study arm will receive the HOBSCOTCH intervention immediately.

Behavioral: HOBSCOTCH

Wait-listed control

NO INTERVENTION

Participants in this study arm will be wait-listed for 6 months and will then receive the HOBSCOTCH intervention.

Interventions

HOBSCOTCH BEHAVIORAL

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. The HOBSCOTCH intervention consists of 8 weekly sessions conducted in-person, over the telephone, or via video-conferencing. A smart phone application will be used to collect data on seizure frequency, medication adherence, and patient engagement.

HOBSCOTCH group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of epilepsy (self-reported by participant), 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 electroencephalogram (EEG) evaluation is acceptable
• Literate
• Telephone access
• Internet access

You may not qualify if:

• Participants self-reporting a dementing illness or a dementing illness appearing in their medical record.
• Severe mental disability or estimated intelligence quotient (IQ) less than 70 per clinical judgement
• Significant visual impairment precluding reading or writing
• No reliable telephone or internet access
• No diagnosis of epilepsy

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Emory Brain Health Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cam Escoffery, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

• Katie Bullinger, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 20, 2020
• Study Start: March 17, 2021
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)