NCT06631105

Brief Summary

This study investigates the capabilities related to diet, physical activity, screening, and knowledge among diabetic adults with or without a history of hospital admissions in Central Florida. The hypothesis is that enhancing these capabilities, based on the Capability Approach framework, can significantly reduce hospital readmissions and improve diabetes management outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

October 4, 2024

Last Update Submit

March 19, 2025

Conditions

Keywords

DiabetesHospital AdmissionHospital

Outcome Measures

Primary Outcomes (1)

  • The assessment of relationships between capabilities and health outcomes using the Structural Equation Modeling (SEM) based on the Capability Approach

    The research employs a survey instrument with Likert-scale and open-ended questions, targeting diabetic adults with or without previous hospital admissions in Central Florida. Structural Equation Modeling (SEM) based on the Capability Approach will be used to analyze the data, allowing for the examination of relationships between capabilities (diet, activity, screening, knowledge) and health outcomes. The SEM will help identify the direct and indirect effects of these capabilities on diabetes management, providing insights into potential intervention points for improving health outcomes in this population.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants must be 18 years of age or older and diagnosed with diabetes to take part in this research study . Participants do not need to have ever been hospitalized to take part in this study. Participants will provide informed consent online and complete the survey online at their convenience. This study is available in English and Spanish.

You may qualify if:

  • Adults over the age of 18.
  • Persons diagnosed with diabetes
  • Have an email account with access to a reliable internet connection or smartphone

You may not qualify if:

  • Minors , ages under 18
  • Adults not diagnosed with diabetes
  • Adults who are unable to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Amoy Fraser, PhD, CCRP, PMP

CONTACT

Britney-Ann Wray, BS, CTBS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

January 10, 2025

Primary Completion

January 10, 2026

Study Completion

January 10, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations