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

Study Overview
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Brief Summary
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Participants will complete a survey before an educational session, during the break of an educational session, or after the session.

Detailed Description
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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

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: CHAT-P


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Diagnosis of type II diabetes Able to speak and understand English Able to provide informed consent Exclusion Criteria: Children under 18 Does not speak or understand English Not of cognitive capacity to provide valid responses Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHAT-P<br>Survey | Other: CHAT-P<br>* Survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHAT-P Score | Total score of 28 item survey. Survey scored using a 5-point scale: Strongly disagree, Disagree, Neutral, Agree, Strongly Agree | Survey administered one time at baseline during the single study visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Self reported demographics, including age, gender, and race | Collected one time at baseline during the single study visit. | 
| Adventist Wholeness Screening | 4 item survey. Q1 is YES/NO. Q2-4 are Yes/No/Not Sure | Collected one time at baseline during the single study visit. | 
| Personal Wellbeing Index | 9 items. Items are scored over an 11-point satisfaction scale with two response anchors of No Satisfaction at All / Completely Satisfied. | Collected one time at baseline during the single study visit. | 
| Multicultural Quality of Life Index | 10 items, answers on a scale of 1-10, with one being Poor and 10 being Excellent. | Collected one time at baseline during the single study visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, type 2 diabetes, diabetes mellitus, type 2 diabetes mellitus, outpatient