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临床试验/NCT03863561
NCT03863561已完成不适用

The Skills, Confidence & Preparedness Index (SCPI) Version 3.0: An Online Version of the SCPI to Evaluate Self-Efficacy of Diabetes Management

LMC Diabetes & Endocrinology Ltd.7 个研究点 分布在 1 个国家目标入组 486 人开始时间: 2017年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
486
试验地点
7
主要终点
Internal consistency of the SCPI (Skills, Confidence & Preparedness Index)

研究概览

简要总结

The LMC Skills, Confidence and Preparedness Index (SCPI) is a tool that was developed by diabetes specialists to individualize the education/support that a healthcare provider delivers to patients with diabetes. It has been shown to have high reliability, validity and generalizability. This study assessed the validity and reliability of a revised, final version of the SCPI in a large sample of patients with type 1 and type 2 diabetes, as well as the clinical responsiveness of the SCPI to a diabetes self-management education intervention in a smaller cohort of patients with poor glycemic control.

详细描述

Canadian experts in diabetes care developed the Skills, Confidence & Preparedness Index (SCPI) to assess diabetes self-management in patients. The SCPI is web-based, gives immediate feedback to the healthcare provider, and is associated with glycemia. The SCPI was designed to allow a healthcare provider to individualize the education/support by assessing the three critical dimensions of self-management: knowledge of a skill; confidence in ability to change a behavior; and preparedness to begin implementing the behavior change. Two previous validation studies showed that the SCPI has high internal consistency, reliability, generalizability, and external validity.

Following further focus groups with healthcare providers and patients, the SCPI questions and response scale were edited to further optimize clarity. This study assessed the validity and reliability of a revised, final version of the LMC SCPI in a large sample of diabetes patients, as well as clinical responsiveness of the SCPI to a diabetes self-management education (DSME) program intervention.

This study recruited type 1 and type 2 patients from the waiting rooms of seven LMC Diabetes & Endocrinology specialist clinics in Ontario, Canada. Patients completed the SCPI electronically and their demographic and health information was retrieved from their electronic medical records. A smaller cohort of patients with uncontrolled glycemia were enrolled into a DSME program. Participants completed the SCPI at their baseline visit and their individual results were incorporated into the care paths that were then customized for that participant. The DSME program provided five to seven visits with a diabetes educator over three to four months. Patients completed the SCPI again at their final visit.

研究设计

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

入排标准

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

入选标准

  • Diagnosis of type 1 or type 2 diabetes
  • Age ≥ 18 years
  • Ability to read English
  • Duration of diabetes ≥ 6 months (DSME cohort only)
  • A1C ≥ 8.0% (DSME cohort only)

排除标准

  • 未提供

结局指标

主要结局

Internal consistency of the SCPI (Skills, Confidence & Preparedness Index)

时间窗: 24-hours

Cronbach's alpha score for the total SCPI score (minimum score 1, maximum score 7) and the three subscales (minimum score 1, maximum score 7) in the waiting room sample. A higher score indicates greater diabetes self-management.

Validity of the SCPI with HbA1c

时间窗: 24-hours

Correlation between the total SCPI score (minimum score 1, maximum score 7) and the three subscale scores (minimum score 1, maximum score 7) with HbA1c in the waiting room sample. A higher SCPI score indicates greater diabetes self-management.

次要结局

  • Test-retest reliability(one week)
  • Change in SCPI score(3 to 4 months)
  • Change in HbA1c(3 to 4 months)
  • Responsiveness of the total SCPI score to an intervention(3 to 4 months)
  • Validity of the SCPI with demographic and diabetes variables(24-hours)
  • Association between total SCPI score and HbA1c(Baseline)
  • SCPI completion time(24-hours)
  • Floor/ceiling effect of the total SCPI score(24-hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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