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临床试验/NCT01945996
NCT01945996已完成不适用

Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter

University of Southern California2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Acceptability 2: Would Patients Recommend the Program to Family or Friends?

研究概览

简要总结

In this study, an existing mobile health intervention to improve diabetes self-management will be combined with a social support module and tested for feasibility. The investigators hypothesize that this combination will be feasible and acceptable to both patients and their loved ones.

详细描述

This will be the first ever evaluation of a highly scalable and low-cost social support intervention for patients with diabetes delivered entirely via mobile phones. TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) will unite the benefits of mHealth (scalability, ease of access) and social support interventions (personalized motivation, emotional support). The Diabetes FANS text message based curriculum will make it easier for friends and family to become supporters. Additionally, augmenting TExT-MED with the FANS social support module will be more effective than TExT-MED alone. The personalized support of TExT-MED FANS will also be more effective than providing TExT-MED in combination with a community health worker supporter who lacks a pre-existing relationship with the patient. Through this innovative combination, I can create a more cost-effective and diffusible mHealth solution that maintains the personal connection of social support interventions. To date there has only been one study evaluating social support interventions for patients with diabetes using mHealth, but in this study participants were paired with other subjects with diabetes (not friends or family) and it required intensive face-to-face support group time. TExT-MED FANS will provide key insights into the utility of combining social support interventions delivered solely via mHealth in low-income Latino patients. These insights will help future interventions achieve maximal impact on diabetes and other chronic disease management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

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

  • type II diabetes
  • HbA1c >or=8 at enrollment
  • speak English or Spanish
  • has support person willing to participate

排除标准

  • unable to consent
  • pediatric patient

研究组 & 干预措施

TExT-MED only

Active Comparator

Patients will receive TExT-MED intervention, but supporters will not receive additional messages

干预措施: TExT MED (Behavioral)

TExT-MED FANS

Experimental

Patients get TExT-MED intervention, supporter gets FANS curriculum

干预措施: TExT MED (Behavioral)

TExT-MED FANS

Experimental

Patients get TExT-MED intervention, supporter gets FANS curriculum

干预措施: FANS (Behavioral)

结局指标

主要结局

Acceptability 2: Would Patients Recommend the Program to Family or Friends?

时间窗: 3 months follow up

Response to: Would you recommend TExT-MED FANS to family or friends?

Feasibility

时间窗: 3 months after enrollment

Number of patients lost to follow-up

Acceptability

时间窗: 3 months after enrollment

Patient response to: I have enjoyed the TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) program?

次要结局

  • Change in Problem Areas in Diabetes Scale(3 months after enrollment)
  • Body Mass Index(3 months after enrollment)
  • Diabetes Knowledge Test Scale(3 months after enrollment)
  • Change in Self-efficacy(3 months after enrollment)
  • Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score(3 months follow up)
  • Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score(3 months follow up)
  • Change in Summary of Diabetes Self-care Activities - General Diet Sub Score(3 months follow up)
  • Change in Summary of Diabetes Self-care Activities - Exercise Sub Score(3 months follow up)
  • Glycemic Control(3 months after enrollment)
  • Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score(3 months follow up)
  • Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score(3 months follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Burner

Assistant Professor of Clinical Emergency Medicine

University of Southern California

研究点 (2)

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