跳至主要内容
临床试验/NCT04820153
NCT04820153已完成不适用

Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders

University of Southern California2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月26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
20
试验地点
2
主要终点
Baseline Demographic Data

研究概览

简要总结

The primary goal of this proposal is to demonstrate the feasibility of using a Fitbit charge to monitor and promote physical activity in a diverse population of Hispanic women with chronic neurological disorders. Hispanic women will also receive behavioral coaching using a Lifestyle Redesign approach to enhance physical activity in their daily lives. The secondary goal of this proposal is to investigate whether changes in physical activity are associated with (i) quality of life including perception of health and well- being and (ii) frequency of hospital and county clinic visits.

详细描述

This pilot study will provide feasibility on use of wearable technology for tracking and self-monitoring physical activity (PA) as well as preliminary data to support our overall approach for promoting PA and improving disease status in a Hispanic women population. A larger application will be submitted to the NIH, DoD, or other federal agency focused on investigating the impact of PA on chronic neurological diseases in a diverse and inclusive Hispanic population in LA County.

2.1.1 Specific Aim 1 establishes feasibility of this approach by measuring adherence and change in PA using a Fitbit alta HR activity monitor in Hispanic women with chronic neurological diseases. Adherence will be determined through: (i) the average hours/day of use; and (ii) the length of time (percent of total study days) of usage throughout the 16-week study. Adherence defined as (i) 5 or more days/week of use and (ii) 10 or more hours of use during the day.

2.1.2 Specific Aim 2 tests the hypothesis that an increase in physical activity will be correlated with a decrease in LA County (LAC) Facilities health care use (hospital and clinic visits). Physical activity will be assessed by change in either: (i) the average number of steps/week; and (ii) average time spent in sedentary, light, or moderate to vigorous intensity based on MET (metabolic expenditure) of physical activity/week. Methods: Changes in PA outcome metrics over the 16-week period will be correlated with the total number of hospital/outpatient clinic visits. Total hospital use will be determined through the LAC/DHS (Department of Human Services) electronic medical records and will include outpatient provider visits, emergency room and urgent care visits, total hospitalizations, and days spent in hospital.

2.1.3 Specific Aim 3a tests the hypothesis that increase in physical activity is associated with an increase in the quality of life (QOL). Physical activity will be measured through: (i) the average number of steps/week; and (ii) average intensity of physical activity/week. QOL will be determined through measures of self-rated health and well-being. These Spanish validated surveys will include illness perception questionnaire and health and well-being questionnaire

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Baseline Demographic Data

时间窗: At Baseline Visit

Baseline demographic data will be obtained which will include age, recent healthcare visit frequency, medical history, medication, years of education, and tobacco use.

Physical Activity Adherence Assessment- Step Count +

时间窗: 16 weeks

Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com). Step Count will be obtained during the course of the study.

Physical Activity Adherence Assessment- Time spent in moderate to vigorous activity

时间窗: 16 weeks

Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com).Time spent in moderate to vigorous activity will be obtained during the course of the study.

Physical Activity Adherence Assessment- length of wear.

时间窗: 16 weeks

Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com). Length of wear will be obtained during the course of the study.

Determination of LA County Facilities Health Care Use- number of inpatient LA County Hospital visits

时间窗: 16 weeks

The investigators will utilize electronic medical record (EMR) system of LA County Department of Health Services (DHS) to determine the number of inpatient hospital visits The total number of visits to the LAC/USC medical center will be determined during the 16-week period prior to study initiation and during the period of the study intervention using electronic medical records. HIPPA guidelines will be followed.

Determination of LA County Facilities Health Care Use- number of LA County Hospital Outpatient visits

时间窗: 16 weeks

The investigators will utilize electronic medical record (EMR) system of LA County Department of Health Services (DHS) to determine the number of outpatient hospital visits. The total number of visits to the LAC/USC medical center will be determined during the 16-week period prior to study initiation and during the period of the study intervention using electronic medical records. HIPPA guidelines will be followed.

次要结局

  • Quality of Life (QOL) Assessment(At Baseline Visit and Week 16)
  • Spanish Acculturation(At Baseline)
  • Brief Illness Perception Questionnaire (BIPQ)(At Baseline and Week 16)
  • Spanish Physical Activity Questionnaire(At Baseline and Week 16)
  • FitBit Wear Technology Questionnaire(At Week 16)

研究者

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

Giselle Petzinger, MD

Clinical Scholar

University of Southern California

研究点 (2)

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