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Take 2 Pills and Go Volunteer in the Morning

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ClinicalTrials.gov Identifier: NCT04038775
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Darnell, Loyola University

Brief Summary:
In this study, doctors will "prescribe" volunteer work for their patients. The investigators are determining whether it is feasible for providers to recommend volunteering to their patients, and whether patients who are recommended this "treatment" actually do volunteer work (i.e., find it "acceptable"). The study is focused on uninsured patients at Loyola Medicine's Access to Care (ATC) Clinic. The study's secondary aim is to determine whether or not engaging in volunteer work yields health benefits.

Condition or disease Intervention/treatment Phase
Volunteers Behavioral: Volunteering Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The first 25 patients are placed into the intervention group (recommended volunteering by their provider) and the next 25 patients are placed into the control group (not recommended volunteering).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Take 2 Pills and Go Volunteer in the Morning: A Feasibility Study of Engaging Patients as Volunteers
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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.
Behavioral: Volunteering
Subjects recommended volunteer by their provider.

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria * Access to Care patient

Exclusion Criteria

* None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038775


Contacts
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Contact: Julie S Darnell, PhD 708-327-9022 jdarnell1@luc.edu

Locations
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United States, Illinois
Access to Care Clinic Recruiting
Maywood, Illinois, United States, 60153
Contact: Matt Fitz, MD    708-216-8757    mfitz1@luc.edu   
Sub-Investigator: Abigail Silva, PhD         
Sub-Investigator: Nallely Mora, MD         
Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Julie S Darnell, PhD Loyola University Chicago
  Study Documents (Full-Text)

Documents provided by Julie Darnell, Loyola University:
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Responsible Party: Julie Darnell, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT04038775    
Other Study ID Numbers: 210989
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a feasibility study. There are no plans to share data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Darnell, Loyola University:
medically uninsured