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临床试验/NCT03988894
NCT03988894Unknown早期 1 期

Design, Usability Testing, and Feasibility Testing of a Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors

University of Toronto0 个研究点目标入组 60 人开始时间: 2020年1月10日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
入组人数
60
主要终点
change of diastolic Blood Pressure from baseline to eight weeks after randomization

研究概览

简要总结

The aim of this proposed study is to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC), a classroom-based antihypertensive dietary educational intervention, to an innovative smartphone app (mDASHNa-CC) to enable Chinese Canadian seniors' access to this antihypertensive dietary intervention anytime, regardless of where they are.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • have a systolic blood pressure higher than 140 mmHg, or a diastolic blood pressure higher than 90mmHg, or are on antihypertensive medications, based on pre-intervention baseline assessment
  • are able to understand (listen) and speak in Mandarin or Cantonese, read and write in Chinese
  • have access to a smartphone

排除标准

  • have special dietary requirements
  • are a household member of another mDASHNa-CC participant
  • plan to leave the area prior to the anticipated end of study

研究组 & 干预措施

Control: Usual Care

No Intervention

All participants will (a) receive a general hypertension health education booklet from the Heart and Stroke Foundation of Ontario;(b) be encouraged to see their family physicians or primary health care providers regarding their blood pressure status; those who do not have a primary health care provider will be referred to a walk-in clinic or a community health centre; and (c) have access to family physicians, tele-health, emergency care, hospital and other health care facilities in the Greater Toronto Area as required.

Intervention: mDASHNa-CC app use

Active Comparator

In addition to usual care, those participants randomized to the intervention group will be offered use of the app.Then, they will load the app in their smartphones and be requested to review educational contents, conduct dietary self-assessment, and monitor blood pressure for 8 weeks.By the end of eight weeks post randomization, seniors will be prompted by phone using an audible alert to complete the app Evaluation Questionnaire on the smartphone, which ascertains likes and dislikes with the app.

干预措施: mDASHNa App (Device)

结局指标

主要结局

change of diastolic Blood Pressure from baseline to eight weeks after randomization

时间窗: eight weeks after randomization

diastolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested

change of Health-related Quality of Life from baseline to eight weeks after randomization

时间窗: eight weeks after randomization

Health-related quality of life will be measured by Medical Outcomes Study 36-Item Short Form version two. The SF-36v2 required ten minutes to complete and consisted of 36 items and eight domains, which could be grouped into physical and mental component summaries. All domains were scored on a scale ranging from 0 to 100, wherein 0 represented the worst overall health status and 100 the best health status.

change of systolic Blood Pressure from baseline to eight weeks after randomization

时间窗: eight weeks after randomization

Systolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested

change of body weight from baseline to eight weeks after randomization

时间窗: eight weeks after randomization

Weight will be measured by an electronic body weight scale (Rubbermaid® Digital Utility Scale, Model number H-479, Capacity/Accuracy 400 lbs \* 0.5 lb)

change of waist circumference from baseline to eight weeks after randomization

时间窗: eight weeks after randomization

Waist circumference will be measured by measurement tape following proper technique

次要结局

未报告次要终点

研究者

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

Ping Zou

Professor

University of Toronto

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