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

Type 2 Diabetes Mellitus Clinical Trial

— CHAT-P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686917
• Other study ID #: 1304646
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2020
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: October 31, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• CHAT-P
Survey

Locations

Country	Name	City	State
United States	Center for Whole-Person Research	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

Billioux, A., Verlander, K., Anthony, S., & Alley, D. (2017). Standardized screening for health-related social needs in clinical settings: The accountable health communities screening tool. Discussion Paper, National Academy of Medicine, Washington, DC. Retrieved from https://nam.edu/wp-content/uploads/2017/05/ Standardized-Screening-for-Health-Related-Social-Needsin-Clinical-Settings.pdf.

Cummings, D., Reed, M., & Chobotar, T. (2015). Creation Health Discovery: Live Life to The Fullest (5th ed.). Maitland, FL: Florida Hospital Publishing.

Polit, D. F. (2009) Data analysis & statistics for nursing research (2nd ed.). Upper Saddle River, NJ: Prentice Hall.

Roozen HG, Wiersema H, Strietman M, Feij JA, Lewinsohn PM, Meyers RJ, Koks M, Vingerhoets JJ. Development and psychometric evaluation of the pleasant activities list. Am J Addict. 2008 Sep-Oct;17(5):422-35. doi: 10.1080/10550490802268678. — View Citation

Stevens, J. (2002). Applied multivariate statistics for the social sciences (4th ed.). Mahwah, NJ: Lawrence Erlbaum Associates

van Bokhorst-de van der Schueren MA, Guaitoli PR, Jansma EP, de Vet HC. Nutrition screening tools: does one size fit all? A systematic review of screening tools for the hospital setting. Clin Nutr. 2014 Feb;33(1):39-58. doi: 10.1016/j.clnu.2013.04.008. Epub 2013 Apr 19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographics	Self reported demographics, including age, gender, and race	Collected one time at baseline during the single study visit.
Secondary	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.
Secondary	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.
Secondary	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.