Neurological Disorder Clinical Trial
Official title:
Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders
Verified date | March 2021 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria includes - (1) Women of Hispanic origin; - (2) established patient of the neurology clinic defined as clinic visits at the LAC/USC Neurology Clinic that have spanned greater than one year; - (3) age > 30 - (4) willing and able to utilize a Fitbit activity Monitor; - (5) own a smart phone device; - (6) ambulatory without assistance; - (7) willing and able to provide informed consent; - (8) within commuting distance to the wellness center and LAC/USC hospital; - (9) reads or comprehends Spanish; - (10) weekly internet access. Exclusion Criteria includes - (1) Clinically significant neurological or psychiatric illness including mental retardation, dementia or severe depression/anxiety; - (2) any physical condition that precludes engagement in exercise, including significant heart disease. |
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline Demographic Data | Baseline demographic data will be obtained which will include age, recent healthcare visit frequency, medical history, medication, years of education, and tobacco use. | At Baseline Visit | |
Primary | Physical Activity Adherence Assessment- Step Count + | 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. | 16 weeks | |
Primary | Physical Activity Adherence Assessment- Time spent in moderate to vigorous activity | 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. | 16 weeks | |
Primary | Physical Activity Adherence Assessment- length of wear. | 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. | 16 weeks | |
Primary | Determination of LA County Facilities Health Care Use- number of inpatient LA County Hospital visits | 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. | 16 weeks | |
Primary | Determination of LA County Facilities Health Care Use- number of LA County Hospital Outpatient visits | 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. | 16 weeks | |
Secondary | Quality of Life (QOL) Assessment | This measure assessed participants' views of their health, how well they feel, and how well they are able to complete their usual activities. The scale is comprised of 16 items with a 1-7 rating scale of points. A higher sum of points indicates feelings of better quality of life and a better outcome. | At Baseline Visit and Week 16 | |
Secondary | Spanish Acculturation | The purpose of this questionnaire is to assess the level to which participants acculturate or adopt the attitudes, values, customs, beliefs, and behaviors of another culture. The scale is comprised of 12 items measured on a scale of 1 to 5, which are averaged. Low acculturation is measured by an average score >2.99. | At Baseline | |
Secondary | Brief Illness Perception Questionnaire (BIPQ) | The purpose of this questionnaire is to assess participants' perceptions of their health and well-being.
Each item of the Brief IPQ assesses one dimension of illness perceptions: The consequences score is simply the response to item 1. The timeline score is the response to item 2 The personal control scores is the response to item 3 The treatment control score is the response to item 4 The identity score is the response to item 5 The coherence score is the response to item 7 The emotional representation is the response to item 8. Illness concern is measured by item 6. This reflects a combination of emotional and cognitive representations. Item 9 is the causal item. Reponses can be grouped into categories such as stress, lifestyle, hereditary, etc. determined by the particular illness studied. Categorical analysis can then be performed, either on just the top listed cause or all three listed causes. |
At Baseline and Week 16 | |
Secondary | Spanish Physical Activity Questionnaire | This self-administered questionnaire determines total physical activity (MET-h week-1 ) and total number of hours sitting down across a week to evaluate the levels of participants' physical activity and sedentary lifestyle. The number of METs (metabolic equivalents) corresponding to each activity are calculated using the Compendium of Physical Activities as the ratio of energy expended during a physical activity to the metabolic rate. Afterwards, the number of METs in each activity is multiplied by the weekly participation in that activity. The estimated number of MET-h week -1 is weighted according to the number of months dedicated to each activity. Recreational physical activity is quantified by summing the MET-h week -1 dedicated to all activities performed during leisure time. Total physical activity (MET-h week -1) is calculated by adding leisure-time physical activity to work physical activity. | At Baseline and Week 16 | |
Secondary | FitBit Wear Technology Questionnaire | The purpose of this questionnaire is to ascertain participants' opinions on the usability of the Fitbit phone application, Fitbit activity monitor, and combination of the Fitbit and Fitbit Application. Participants score questions pertaining to usability on a scale of 1 (strongly disagree) to 5 (strongly agree). These scores are averaged and expressed as a percentage of 100, with higher scores indicating greater usability. | At Week 16 |
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