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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03686917
Acronym
CHAT-P
Enrollment
260
Registered
2018-09-27
Start date
2018-10-01
Completion date
2019-10-31
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, type 2 diabetes, diabetes mellitus, type 2 diabetes mellitus, outpatient

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

Interventions

OTHERCHAT-P

Survey

Sponsors

AdventHealth
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18 and above 2. Diagnosis of type II diabetes 3. Able to speak and understand English 4. Able to provide informed consent

Exclusion criteria

1. Children under 18 2. Does not speak or understand English 3. Not of cognitive capacity to provide valid responses 4. Prisoners

Design outcomes

Primary

MeasureTime frameDescription
CHAT-P ScoreSurvey 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

MeasureTime frameDescription
DemographicsCollected one time at baseline during the single study visit.Self reported demographics, including age, gender, and race
Adventist Wholeness ScreeningCollected one time at baseline during the single study visit.4 item survey. Q1 is YES/NO. Q2-4 are Yes/No/Not Sure
Personal Wellbeing IndexCollected 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 IndexCollected 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026