NCT02970396

Brief Summary

This is an investigation of adult individuals with epilepsy, and involves educational and behavioral interventions intended to enhance treatment adherence and self-management. The investigators are adapting a self-management intervention that they developed in a previous study to individuals with epilepsy and a history of negative health events (NHEs), such as accidents and emergency department (ED) visits, diminished quality of life and poor mental well-being. The intervention "Self-management for people with epilepsy and a history of negative health events (SMART)" is intended to reduce NHEs and improve quality of life in people with epilepsy associated with historically disadvantaged groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

4.3 years

First QC Date

November 18, 2016

Last Update Submit

December 13, 2018

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Change in number of negative health events

    baseline, 6 months

Study Arms (2)

SMART Intervention

ACTIVE COMPARATOR

Participants (a total of 120 individuals) will be randomly assigned to either SMART (N=60) or the wait-list control (N= 60), in a 1:1 ratio.

Behavioral: self-management

Wait-list

ACTIVE COMPARATOR

Participants assigned to the wait-list will start the SMART intervention 6 months following randomization.

Behavioral: self-management

Interventions

self-managementBEHAVIORAL
SMART InterventionWait-list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of epilepsy
  • Negative health event within the last 6 months
  • Able to provide written consent and participate in study procedures

You may not qualify if:

  • Immediate risk of self-harm
  • Dementia
  • Pregnancy
  • Unable to read/understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Design

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

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 22, 2016

Study Start

September 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 17, 2018

Record last verified: 2018-12

Locations

US(1)