Validation of a CREATION Health Assessment Tool for Patients in a Diabetic Outpatient Population
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT03686917
- Lead Sponsor
- AdventHealth
- Brief 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"
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- Age 18 and above
- Diagnosis of type II diabetes
- Able to speak and understand English
- Able to provide informed consent
- Children under 18
- Does not speak or understand English
- Not of cognitive capacity to provide valid responses
- Prisoners
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CHAT-P Score Survey administered one time at baseline during the single study visit. Total score of 28 item survey. Survey scored using a 5-point scale: Strongly disagree, Disagree, Neutral, Agree, Strongly Agree
- Secondary Outcome Measures
Name Time Method Adventist Wholeness Screening Collected one time at baseline during the single study visit. 4 item survey. Q1 is YES/NO. Q2-4 are Yes/No/Not Sure
Demographics Collected one time at baseline during the single study visit. Self reported demographics, including age, gender, and race
Personal Wellbeing Index Collected one time at baseline during the single study visit. 9 items. Items are scored over an 11-point satisfaction scale with two response anchors of No Satisfaction at All / Completely Satisfied.
Multicultural Quality of Life Index Collected one time at baseline during the single study visit. 10 items, answers on a scale of 1-10, with one being "Poor" and 10 being "Excellent".
Trial Locations
- Locations (1)
Center for Whole-Person Research
🇺🇸Orlando, Florida, United States
Center for Whole-Person Research🇺🇸Orlando, Florida, United States