NCT03686917

Validation of a CREATION Health Assessment Tool for Patients in a Diabetic Outpatient Population

Validation of a CREATION Health Assessment Tool for Patients (CHAT-P) in a Diabetic Outpatient Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 260 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Participants will complete a survey before an educational session, during the "break" of an educational session, or after the session.

Detailed description

Participants will be recruited from diabetes education sessions at selected locations and at FHMG physician practices. For the diabetes education setting, ta research team member will introduce this study to a group of patients before educational sessions, during "break" of the educational sessions, and after sessions. If the patient is interested, an envelope with the Invitation to Participant letter attached to it and the survey enclosed will be given to them. Also, a NOTE will be attached to the envelope with the instructions: "Please drop your completed survey in the drop-box at \_\_\_." The drop-box location will be identified within each setting and provided to the participants in the note or indicated verbally. For patients at physician practices, an envelope with the Invitation to Participant letter attached to it and survey enclosed will be given by a staff member. Invitation to Participant letter contains all portions of the consent process. A NOTE will be attached to the envelope with the instructions: "Please drop your completed survey in the drop box at\_\_\_\_." The drop-box location will be identified within each setting and provided to the participants in the note or indicated verbally. If patient does not meet the inclusion criteria, they will be asked to return the envelope to the staff member who provided it. Patients will be provided with Invitation to Participate letter along with survey. The Invitation to Participate letter provides patients with study details including inclusion/exclusion criteria, duration of participation, procedures to ensure confidentiality, and an overview of voluntary participation conditions. Implied consent will be used. In addition to the Invitation to Participate letter, there is a statement at the top of the survey "return of completed surveys implies consent to participate in the study"

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	CHAT-P	Survey

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-09-01
• Completion: 2019-10-31
• First posted: 2018-09-27
• Last updated: 2020-03-04

Locations

1 site across 1 country: United States