Take 2 Pills and Go Volunteer in the Morning
|ClinicalTrials.gov Identifier: NCT04038775|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Volunteers||Behavioral: Volunteering||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038775
|Contact: Julie S Darnell, PhDemail@example.com|
|United States, Illinois|
|Access to Care Clinic||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Matt Fitz, MD 708-216-8757 firstname.lastname@example.org|
|Sub-Investigator: Abigail Silva, PhD|
|Sub-Investigator: Nallely Mora, MD|
|Principal Investigator:||Julie S Darnell, PhD||Loyola University Chicago|