NCT03520777

Brief Summary

The purpose of the study is to assess the feasibility of a Creative Artists Program intervention with epilepsy and headache patients admitted to Dartmouth-Hitchcock Medical Center for care by the Department of Neurology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

April 13, 2018

Last Update Submit

July 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of conducting a creative arts intervention study

    The feasibility of the creative intervention will be determined by the completion rates of the initial intervention attempts. If less than 50% of patients complete the intervention it will be deemed unfeasible in the current format.

    Through study completion, approximately 1 year

Secondary Outcomes (5)

  • Change in patient anxiety before and after the intervention

    Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).

  • Change in patient distress before and after the intervention

    Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).

  • Change in patient depression before and after the intervention

    Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).

  • Change in frequency of as-needed pain medication use

    Each patient as-needed medication use will be assessed after the arts intervention and until discharge from the hospital (approximately Day 3 - 21).

  • Length of hospital stay

    Each patient's admission duration (approximately 3 - 21 Days).

Study Arms (1)

Artist Intervention

OTHER

One of the three artists (visual artist, music therapist, creative writer) will work with subjects for up to 90 minutes.

Other: Art Intervention

Interventions

Type of artist intervention will be determined by the subject and the assigned artist.

Artist Intervention

Eligibility Criteria

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

You may qualify if:

  • Age \> or = 18 years
  • Diagnosis of refractory chronic epilepsy, status migrainosus, or chronic daily headache
  • Elective admission to the Dartmouth-Hitchcock Medical Center Epilepsy monitoring unit or Headache service
  • Capable of giving informed consent

You may not qualify if:

  • Active psychiatric illness that prohibits safe visitation by artists
  • Impairment of vision or hearing that would prohibit able to participate with participation in instructions necessary for the interventions.
  • Active general medical condition that would impair consciousness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

EpilepsyMigraine Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, PrimaryHeadache Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 11, 2018

Study Start

September 19, 2017

Primary Completion

June 1, 2018

Study Completion

June 30, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations