NCT03304535

Brief Summary

The purpose of this research study is to determine whether involvement with a social worker helps reduce distress, depression, and increase patient activation in participants over a 6 month intervention period. The study will also describe common barriers to care that participants face.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

1.6 years

First QC Date

February 22, 2016

Last Update Submit

October 3, 2017

Conditions

Glaucoma

Keywords

GlaucomaSocial Worker

Outcome Measures

Primary Outcomes (1)

  • Change in response to Patient Health Questionnaire 9

    Measures participant levels of depression based on questions related to depressive symptoms. The investigator will assess change in the number of participants with major, moderate, and minimal depressive symptoms.

    6 months

Secondary Outcomes (3)

  • Change in response to Distress thermometer

    6 months

  • Change in response to Modified Patient Activation Measure 13

    6 months

  • Descriptive results of the Social Worker Baseline Assessment

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with any type of Glaucoma

You may qualify if:

  • Patients seen at Wills Eye Hospital in the Glaucoma Service
  • Glaucoma of any type, characterized by glaucomatous optic neuropathy and corresponding visual field (VF) defect
  • Referred to staff social worker for intervention
  • Ability to read, write, speak and understand English

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Fudemberg SJ, Amarasekera DC, Silverstein MH, Linder KM, Heffner P, Hark LA, Waisbourd M. Overcoming Barriers to Eye Care: Patient Response to a Medical Social Worker in a Glaucoma Service. J Community Health. 2016 Aug;41(4):845-9. doi: 10.1007/s10900-016-0162-1.

    PMID: 26860278BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Scott J Fudemberg, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2016

First Posted

October 9, 2017

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)