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临床试验/NCT03686917
NCT03686917已完成不适用

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

AdventHealth1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AdventHealth
入组人数
260
试验地点
1
主要终点
CHAT-P Score

研究概览

简要总结

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

详细描述

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"

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and above
  • Diagnosis of type II diabetes
  • Able to speak and understand English
  • Able to provide informed consent

排除标准

  • Children under 18
  • Does not speak or understand English
  • Not of cognitive capacity to provide valid responses

结局指标

主要结局

CHAT-P Score

时间窗: 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

次要结局

  • Adventist Wholeness Screening(Collected one time at baseline during the single study visit.)
  • Demographics(Collected one time at baseline during the single study visit.)
  • Personal Wellbeing Index(Collected one time at baseline during the single study visit.)
  • Multicultural Quality of Life Index(Collected one time at baseline during the single study visit.)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (1)

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