Clinical trial NCT03686917: Validation of a CREATION Health Assessment Tool for Patients in a Diabetic Outpatient Population
Official title: Validation of a CREATION Health Assessment Tool for Patients (CHAT-P) in a Diabetic Outpatient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
type 2 diabetes
diabetes mellitus
type 2 diabetes mellitus
outpatient
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with type 2 diabetes mellitus

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"

Eligibility criteria: 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

Primary outcomes:
measure: CHAT-P Score
timeFrame: Survey administered one time at baseline during the single study visit.
Secondary outcomes:
measure: Demographics
timeFrame: Collected one time at baseline during the single study visit.
measure: Adventist Wholeness Screening
timeFrame: Collected one time at baseline during the single study visit.
measure: Personal Wellbeing Index
timeFrame: Collected one time at baseline during the single study visit.
measure: Multicultural Quality of Life Index
timeFrame: Collected one time at baseline during the single study visit.
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Center for Whole-Person Research
state: Florida
Study officials:
affiliation: AdventHealth
name: Hong Tao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cummings, D., Reed, M., & Chobotar, T. (2015). Creation Health Discovery: Live Life to The Fullest (5th ed.). Maitland, FL: Florida Hospital Publishing.
citation: Polit, D. F. (2009) Data analysis & statistics for nursing research (2nd ed.). Upper Saddle River, NJ: Prentice Hall.
citation: 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.
citation: Stevens, J. (2002). Applied multivariate statistics for the social sciences (4th ed.). Mahwah, NJ: Lawrence Erlbaum Associates
citation: 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.