Health TrialsbyHealthPanel

Florida Community-Engaged Research Alliance (FL-CEAL)

ConditionHealth, Subjective
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorUniversity of Miami

About this trial

The purpose of the study is learn more about ways to help people with non-medical issues that can affect participant health. The study team will examine if Community Health Workers, members of a community who provide basic health and medical care within communities, are more helpful to people with non-medical issues than simple reading materials on how participants can do it themselves.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals living within the target community who do not plan to move out of the community within the next six months

Having two un-met SDOH needs

Age 18 and over

Age 18 and over

Disqualifiers

Are unable or unwilling to consent

Plans to move out of the community during the next six months

Enrollment in a research study addressing Social Determinants Of Health (SDOH) in the last three years.

Prisoners

Trial design

Design model

Parallel

Treatments tested in this trial

  • Community health workers (CHW)

    Behavioral

    Participants will meet with a Community Health Worker (CHW) who will help facilitate and provide personalized navigation to existing resources for addressing health challenges such as food insecurity and access to care. CHW will meet with participants in person or virtually at least three times for approximately 15-60 minutes for over the six month period

  • Educational Materials

    Behavioral

    Participants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Community Health worker GroupExperimental treatment 1 intervention
Group B: Educational material groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)

In the PWI, each item is rated on a 0-to-10 scale (0 = No satisfaction at all; 10 = Very satisfied).

Time frame
Baseline, 6 months

Secondary outcomes

1

Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)

Health insurance status will measured by the number of participants who answered yes to the health insurance status

Time frame
Baseline, 6 months
2

Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4)

Having a usual source of care will measured by the number of participants who answered yes to having usual source of care

Time frame
Baseline, 6 months
3

Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4)

Delayed medical care will measured by the number of participants who answered yes to having delayed medical care due the cost.

Time frame
Baseline, 6 months
4

Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire

Food security status is assigned as follows: Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale) Raw score 2-4-Low food security Raw score 5-6-Very low food security

Time frame
Baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Westat

Collaborator

Source ClinicalTrials.gov
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