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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03304535
Other study ID # IRB#15-XXX
Secondary ID
Status Completed
Phase N/A
First received February 22, 2016
Last updated October 3, 2017
Start date January 2016
Est. completion date August 2017

Study information

Verified date October 2017
Source Wills Eye
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

An appointment will be scheduled for participant to meet with a social worker. The appointment may happen on day of participant's scheduled clinic appointment or on another mutually decided upon date and time. Should participant choose to participate, this first visit will be Visit 1 for the study.

Visit 1: Baseline

Informed consent will be obtained demonstrating an interest in participating.

A visit with the social worker will take place during Visit 1. This session will be held in a private office and allows participant time for discussion regarding any challenges, struggles and/or barriers they may be experiencing.

The following baseline questionnaires/surveys will be administered:

Modified Patient Activation Measure - measures participant confidence in taking care of their own health.

Distress Thermometer - measures participant distress level during the past week.

Patient Health Questionnaire -measures depression symptoms and severity if any.

Clinical information will be taken from participant's medical record. There may be follow-up questions related to data if information is unclear or incomplete.

Upon completion of Visit 1, participant will receive a satisfaction survey to evaluate how participant satisfaction with social worker interaction.

Social Worker Interventions: After Visit 1 and before Visit 2

The social worker will develop an intervention for participant during Visit 1 appointment. As many calls or in person meetings participant requires will take place. There will be no limit and it will be determined by participant's needs.

Visit 2: Follow-up After 6 Months

Upon completion of participant's six month follow-up in the study, the following questionnaires/surveys will be administered:

Modified Patient Activation Measure - measures how confident participant is at taking care of their own health.

Distress Thermometer - measures how much distress participant has been experiencing in the past week.

Patient Health Questionnaire - measures if participant has symptoms of depression and the severity of those symptoms.

Satisfaction Survey - measures how satisfied participant is with the social worker interaction.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wills Eye Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in response to Distress thermometer Measures participant level of distress on a scale of 1 to 10 and asks additional questions regarding contributors to distress. 6 months
Secondary Change in response to Modified Patient Activation Measure 13 Measures participant self-capacity for and confidence regarding glaucoma management. 6 months
Secondary Descriptive results of the Social Worker Baseline Assessment Social worker will assess each participant's internal and external barriers to care, limitations, and strengths that may help them to manage their glaucoma. 6 months
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