Active — Not RecruitingNot Applicable

HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)

United States160 participantsStarted 2022-03-21

Plain-language summary

The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-PTE, to improve the quality of life and cognitive function in Service Members, Veterans and civilians with post traumatic epilepsy (PTE). This study will also assess the ability of the HOBSCOTCH-PTE program to improve quality of life in caregivers of PTE patients and to reduce caregiver burden.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria/PTE Participants: * Age 18+ * Diagnosis of post traumatic 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 and proficient in English * Telephone access * Internet access Exclusion Criteria/PTE Participants: * 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 Inclusion Criteria/Caregiver Participants * Age 18+ * Caregivers to a patient with a confirmed diagnosis of PTE * Literate and proficient in English * Telephone access * Internet access Exclusion Criteria/Caregiver Participants: * Significant visual impairment precluding reading or writing * No reliable telephone or internet access

What they're measuring

Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE

Timeframe: Baseline and 3 months post-intervention.

Change in subjective cognition as measured by comparing NeuroQOL - Cognitive Function sub-scale scores at baseline and 3 months post-intervention in participants with PTE

Timeframe: Baseline, 3 months, 6 months

Change in caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention in caregivers of PTE participants

Timeframe: Baseline and 3 months post-intervention

Trial details

NCT IDNCT05235061

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Epilepsy, Traumatic trials