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NCT Number: NCT02394509

HOBSCOTCH Phase II

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center, Portland, Maine, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

HOBSCOTCH Phase II: A Pragmatic Study of HOBSCOTCH in New England.

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2015
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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