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

March 3, 2020 updated by: AdventHealth

Validation of a CREATION Health Assessment Tool for Patients (CHAT-P) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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"

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Center for Whole-Person Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with type 2 diabetes mellitus

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CHAT-P
Survey
Other: CHAT-P
Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Survey administered one time at baseline during the single study visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Collected one time at baseline during the single study visit.
Self reported demographics, including age, gender, and race
Collected one time at baseline during the single study visit.
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
Collected one time at baseline during the single study visit.
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.
Collected one time at baseline during the single study visit.
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".
Collected one time at baseline during the single study visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1304646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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