Take 2 Pills and Go Volunteer in the Morning

July 28, 2019 updated by: Julie Darnell, Loyola University

Take 2 Pills and Go Volunteer in the Morning: A Feasibility Study of Engaging Patients as Volunteers

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Illinois
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Access to Care Clinic
        • Contact:
        • Sub-Investigator:
          • Abigail Silva, PhD
        • Sub-Investigator:
          • Nallely Mora, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria * Access to Care patient

Exclusion Criteria

* None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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.
Baseline to six months

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.
Baseline to six months
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.
Baseline to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julie S Darnell, PhD, Loyola University Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

July 28, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 28, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 210989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a feasibility study. There are no plans to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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