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临床试验/NCT02378012
NCT02378012终止不适用

Project BUCKiPAD: The Evaluation of an iPAD Distribution Program on Anxiety and Depression in Bone and Marrow Transplant Patients

Ohio State University Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
Change in Hospital Anxiety and Depression Scale (HADS)-Anxiety score

研究概览

简要总结

This randomized clinical trial studies iPad use in reducing anxiety and depression in patients undergoing bone marrow transplant. A tablet device like the iPad can provide access to music, television, movies, books, and the Internet. It also contains a video conferencing system that can allow patients to communicate with family members and other members of their social support team. With these capabilities, an iPad distribution program may help lessen patient anxiety and depression during a hospital stay. Monitoring iPad use by patients may help doctors better understand how patients use their computers and tablets while in the hospital so that the software and applications of the iPad can be made more useful.

详细描述

PRIMARY OBJECTIVES:

I. To evaluate the effect access to an iPad has on anxiety as measured by the Hospital Anxiety and Depression Scale.

SECONDARY OBJECTIVES:

I. Determine how computers and tablets are used by patients who have access to such devices.

OUTLINE: Participants are assigned to Group A or randomized to 1 of 2 groups (Groups B or C).

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
None

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

  • Adult patients undergoing treatment in the bone marrow transplant (BMT) unit on the 3rd floor of the James Cancer Hospital and Solove Research Institute
  • Patients receiving reduced intensity chemotherapy for an allogeneic stem cell transplant

排除标准

  • Patients who lack the visual or motor skills necessary to use a tablet device like the Apple iPad
  • Criteria for visual proficiency will be determined by asking the patient: do you have trouble reading a newspaper even with your glasses or contacts (if you wear them); if "yes", they will be excluded
  • Criteria for motor skill proficiency will be determined by asking the patient: do you have any trouble using a television remote control; if "yes", they will be excluded
  • Patients who do not speak English

结局指标

主要结局

Change in Hospital Anxiety and Depression Scale (HADS)-Anxiety score

时间窗: Baseline to day 10

Will be analyzed using an analysis of covariance (ANCOVA) model containing fixed effects of treatment condition (iPAD vs. no iPAD), baseline HADS-Anxiety score, and a random, normally distributed error term. The data will be log-transformed prior to analysis, so all resulting inferences will be based on the geometric mean instead of the arithmetic mean.

次要结局

  • Change in HADS depression score(Baseline to day 10)
  • Change in Profile of Mood States Short Form (POMS-SF) scores(Baseline to day 10)

研究者

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

Samantha Jaglowski

Principal Investigator

Ohio State University Comprehensive Cancer Center

研究点 (2)

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