Validation of a CREATION Health Assessment Tool for Patients in a Diabetic Outpatient Population (CHAT-P)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03686917 |
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Recruitment Status :
Completed
First Posted : September 27, 2018
Last Update Posted : March 4, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Type 2 Diabetes Mellitus | Other: CHAT-P |
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"
| Study Type : | Observational |
| Actual Enrollment : | 260 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Validation of a CREATION Health Assessment Tool for Patients (CHAT-P) in a Diabetic Outpatient Population |
| Actual Study Start Date : | October 1, 2018 |
| Actual Primary Completion Date : | September 1, 2019 |
| Actual Study Completion Date : | October 31, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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CHAT-P
Survey
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Other: CHAT-P
Survey |
- CHAT-P Score [ Time Frame: 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
- Demographics [ Time Frame: Collected one time at baseline during the single study visit. ]Self reported demographics, including age, gender, and race
- Adventist Wholeness Screening [ Time Frame: Collected 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 Index [ Time Frame: 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 [ Time Frame: 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".
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686917
| United States, Florida | |
| Center for Whole-Person Research | |
| Orlando, Florida, United States, 32804 | |
| Principal Investigator: | Hong Tao, PhD | AdventHealth |
| Responsible Party: | AdventHealth |
| ClinicalTrials.gov Identifier: | NCT03686917 |
| Other Study ID Numbers: |
1304646 |
| First Posted: | September 27, 2018 Key Record Dates |
| Last Update Posted: | March 4, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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diabetes type 2 diabetes diabetes mellitus type 2 diabetes mellitus outpatient |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |