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OpenTrials
Completed

NCT Number: NCT03686917

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

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

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Whole-Person Research

Orlando, Florida, 32804, United States

About this study

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"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHAT-P

Other

Survey

Primary outcomes

  1. 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

Secondary outcomes

  1. Demographics

    Time frame: Collected one time at baseline during the single study visit.

    Self reported demographics, including age, gender, and race

  2. 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

  3. 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.

  4. 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".

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

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

Acronym: CHAT-P

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2018
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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