- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04038775
Take 2 Pills and Go Volunteer in the Morning
Take 2 Pills and Go Volunteer in the Morning: A Feasibility Study of Engaging Patients as Volunteers
Study Overview
Detailed Description
In this feasibility study, doctors will "prescribe" volunteer work for their patients. The setting is Loyola Medicine's Access to Care Clinic, which serves patients who are low-income and uninsured (and often members of racial/ethnic minority groups). The investigators are determining whether it is feasible for providers in a low-resourced primary care setting to recommend volunteering to their patients, and whether patients who are recommended this "treatment" actually do volunteer work (and how much). The investigators are also interested in measuring whether volunteering is associated with any potential health benefits, specifically well-being and self-esteem.
Promoting volunteerism is the intervention because research evidence suggests that volunteer work may be good for one's health. For example, research shows that volunteering is associated with numerous potential health benefits: improved mental health, increased physical activity, higher preventive health care utilization, lower cardiovascular risk and lower mortality. Besides better health, volunteering also can teach valuable skills, help individuals meet others, and foster new relationships.
Despite all these potential benefits, rates of volunteering are low. Overall, just one in four people volunteers. Additionally, people who have lower incomes are less likely to volunteer (14% of people with incomes below $20,000 vs. 35% of people with incomes above $100,000. And minority groups are less likely to volunteer than whites (just 19% of African Americans and 15% of Latinos compared with 26% of Whites).
Thus, the intervention is aimed to increase volunteer participation rates among groups unlikely to volunteer: low-income uninsured persons who are members of racial/ethnic minority groups.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julie S Darnell, PhD
- Phone Number: 708-327-9022
- Email: jdarnell1@luc.edu
Study Locations
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Illinois
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Maywood, Illinois, United States, 60153
- Recruiting
- Access to Care Clinic
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Contact:
- Matt Fitz, MD
- Phone Number: 708-216-8757
- Email: mfitz1@luc.edu
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Sub-Investigator:
- Abigail Silva, PhD
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Sub-Investigator:
- Nallely Mora, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria * Access to Care patient
Exclusion Criteria
* None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Volunteering
The experimental arm will receive a volunteer "prescription" from their provider and assistance from a study team member to find a volunteer job.
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Subjects recommended volunteer by their provider.
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No Intervention: Control
The control arm will not be recommended to volunteer or assisted in finding a volunteer activity.
They will answer the same survey questions as the intervention subjects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total volunteer hours
Time Frame: Baseline to six months
|
Investigators will sum the reported volunteer hours, which will be tracked at baseline and monthly for 6 months.
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Baseline to six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Rosenberg Self-Esteem Scale Score
Time Frame: Baseline to six months
|
Using the Rosenberg Self-Esteem Scale, investigators will compare changes in the total score from baseline to six months.
The minimum score is 10 and the maximum score is 40.
Higher scores indicate a better outcome, i.e, higher self-esteem.
The Rosenberg Self-Esteem Scale is administered twice: at baseline and at six months after baseline.
|
Baseline to six months
|
Change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Short Form Scale
Time Frame: Baseline to six months
|
Using the PROMIS Global Health Short Form Scale, investigators will compare changes in the physical and mental subscores from baseline to six months.
Higher scores reflect a better outcome, i.e., better functioning.
The range of both the physical and mental health subscales range from 2 to 10. Raw scores will be converted to t-scores to facilitate interpretation.
The PROMIS Global Health Short Form is administered twice: at baseline and at six months after baseline.
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Baseline to six months
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Change in the Arizona Integrative Outcomes Scale
Time Frame: Baseline to six months
|
Using the Arizona Integrative Outcomes Scale (AIOS), a visual analogue measure of well-being, investigators will compare changes from baseline to six months.
Scores range from 0 to 100, with higher scores reflecting a better outcome, i.e., better well-being.The AIOS is administered twice: at baseline and at six months after baseline.
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Baseline to six months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie S Darnell, PhD, Loyola University Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 210989
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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