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临床试验/NCT02128854
NCT02128854已完成不适用

Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年8月14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
60
试验地点
2
主要终点
Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities

研究概览

简要总结

The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural African American (AA) adults in South Carolina (SC) for assessing the usefulness of tablet-based resources in good diabetes self-management behaviors, and (2) to test a tablet-aided intervention for improving diabetes self-management behaviors

详细描述

The proposed study will assess the feasibility of recruitment of African American adults residing in rural South Carolina who will assist with improving the usability of tablet computers. In addition, we will implement a pilot trial of the TABLETS (Tablet-Aided BehavioraL intervention Effect on Self-management skills) intervention for diabetes, using motivational strategies, among rural African Americans. The proposed project is designed to address 3 important issues: recruitment for a hard-to-reach population, utility of technology-enabled intervention, and development of a tablet-aided intervention tailored to understand best practices for diabetes self-management

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
45 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥45 years
  • Clinical diagnosis of diabetes with HbA1c ≥8% and either diagnosis of hyperlipidemia with LDL >100mg/dL or hypertension with BP >140/80mmHg
  • Self-identified as African American
  • Residence in a 4G cellular service area
  • Able to communicate in English

排除标准

  • Cognitive impairment
  • Active alcohol or drug abuse/dependency
  • Acute decompensation of chronic conditions precluding participation
  • Participation in other diabetes clinical trials
  • A life expectancy <6 months

结局指标

主要结局

Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities

时间窗: 6 months post-randomization

This will be done to assess self-management behaviors for diabetes.

Physical Activity Score on the Global Physical Activity Questionnaire

时间窗: 6 months post-randomization

Information will be collected to assess physical activity in three domains and sedentary behaviors.

Medication Adherence on the Morisky Medication Adherence Scale

时间窗: 6 months post-randomization

Scale will be used to assess specific medication-taking behaviors.

Diet Score on the Rapid Eating and Activity Assessment for Participants

时间窗: 6 months post-randomization

Dietary intake will be assessed.

次要结局

  • Quality of Life Using the Medical Outcomes Study Short Form(6 months post-randomization)
  • Glycosylated Hemoglobin A1c (HbA1c)(6 months post-randomization)
  • Low-Density Lipoprotein Cholesterol (LDL-c)(6 months post-randomization)
  • Blood Pressure(6 months post-randomization)
  • Cardiovascular Disease (CVD) Risk Using the Framingham Risk Score(6 months post-randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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