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临床试验/NCT02612402
NCT02612402Unknown不适用

The Effect of a Smartphone Application for Encouraging Physical Activity on the Amount of Activity Performed by Patients With Diabetes or Hematological Malignancies

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
270
试验地点
1
主要终点
increase in daily physical activity

研究概览

简要总结

A smartphone app will be installed on smartphones of patients with type 2 diabetes or hematologic malignancies that do not exercise. The app will send SMS messages to encourage exercise. The exercise will be quantified by the smartphone accelerometer and clinical data, including HbA1c will be collected.

详细描述

The aim of the study is to increase patients' physical activities by using a dedicated cellular application that will encourage patients to adhere to their doctor recommendation on a personal basis.

Primary outcome In diabetic patients: measuring an increase in daily physical activity In cancer patients: improvement of quality of life in correlation with the level of physical activity

Secondary outcomes In diabetic patients: improved glycemic control as assessed by sequential blood tests for HbA1c.

The patients will fill quality of life questionnaires (SF36) at recruitment and after 6 months. After 6 months the patients will also fill a questionnaire about their experience of using the app.

Each recruited patient will have an Android based smart phone. Each patient will provide:

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of diabetes type 2 with HbA1c over 6.5% and no regular exercise for arm A.
  • Newly diagnosed lymphoma, CLL or MM which require chemotherapy for arm B.
  • Patients in both arms should hold an android based smartphone.
  • Patients must be able to read Hebrew.

排除标准

  • Unable to legally consent
  • unstable or stable angina pectoris

结局指标

主要结局

increase in daily physical activity

时间窗: 6 months

The app records the amount of daily walking using the smartphone accelerometer. The amount of activity and pace of walking is compared to those performed on previous days.

次要结局

  • glycemic control(6 months)

研究者

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

Irit HOCHBERG MD

Attending physician, Institute of Endocrinology, Diabetes and Metabolism

Rambam Health Care Campus

研究点 (1)

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