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Completed

NCT Number: NCT04519775

HOBSCOTCH Phase III

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).

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

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 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.

Who can participate

Healthy volunteers accepted: No

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

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

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.

Other names: HOBSCOTCH

Primary outcomes

  1. Change in quality of life

    Time frame: Baseline and at months 3, 6, 9, 12

    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.

  2. Change in cognitive function

    Time frame: Baseline and at months 3, 6, 9, 12

    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 outcomes

  1. Change in depression

    Time frame: Baseline and at months 3, 6, 9, 12

    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.

  2. Change in self-management practices

    Time frame: Baseline and at months 3, 6, 9, 12

    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.

  3. Changes in self-reported seizure frequency

    Time frame: Ongoing through entire study baseline - 12 months

    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.

  4. Changes in medication adherence

    Time frame: Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12

    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.

  5. Changes in health confidence

    Time frame: Baseline and at months 3, 6, 9, 12

    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.

  6. Changes in healthcare utilization

    Time frame: Baseline and at months 3, 6, 9, 12

    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.

  7. Changes in overall well-being

    Time frame: Ongoing through entire study baseline - 12 months

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2020
Registry last updated
Jul 1, 2025

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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