NCT04038775

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

May 29, 2019

Last Update Submit

July 28, 2019

Conditions

Keywords

medically uninsured

Outcome Measures

Primary Outcomes (1)

  • Total volunteer hours

    Investigators will sum the reported volunteer hours, which will be tracked at baseline and monthly for 6 months.

    Baseline to six months

Secondary Outcomes (3)

  • Change in Rosenberg Self-Esteem Scale Score

    Baseline to six months

  • Change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Short Form Scale

    Baseline to six months

  • Change in the Arizona Integrative Outcomes Scale

    Baseline to six months

Study Arms (2)

Volunteering

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

VolunteeringBEHAVIORAL

Subjects recommended volunteer by their provider.

Volunteering

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • \* None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Access to Care Clinic

Maywood, Illinois, 60153, United States

RECRUITING

Study Officials

  • Julie S Darnell, PhD

    Loyola University Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie S Darnell, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 29, 2019

First Posted

July 31, 2019

Study Start

May 28, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

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

Locations