GlaucomaNCT03304535
Social Worker in an Eye-Care Service
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with any type of Glaucoma
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Impact of a Social Worker in a Glaucoma Eye-Care Service: A Prospective Study
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.
Read the detailed 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.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Social Worker
- Medical subject headings
- Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
Change in response to Modified Patient Activation Measure 13
Measures participant self-capacity for and confidence regarding glaucoma management.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Fudemberg, MD, Wills Eye
- Investigators
- Scott J Fudemberg, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304535
- Sponsor's protocol ID
- IRB#15-XXX
- Status last verified
- Oct 2017
- First submitted
- 22 Feb 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26860278
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Social Worker in a Glaucoma Eye-Care Service: A Prospective Study
- ClinicalTrials.gov ID
- NCT03304535
- Acronym / sponsor ID
- IRB#15-XXX
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Social Worker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with any type of Glaucoma
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in response to Patient Health Questionnaire 9
Time frame: 6 months
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.
3 secondary outcomes
Change in response to Distress thermometer
Time frame: 6 months
Change in response to Modified Patient Activation Measure 13
Time frame: 6 months
Descriptive results of the Social Worker Baseline Assessment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Background: PubMed 26860278Fudemberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott J Fudemberg, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in response to Patient Health Questionnaire 9 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03304535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.