Clinical trial NCT04820153: Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders
Official title: Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Disorder
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline Demographic Data
timeFrame: At Baseline Visit
measure: Physical Activity Adherence Assessment- Step Count +
timeFrame: 16 weeks
measure: Physical Activity Adherence Assessment- Time spent in moderate to vigorous activity
timeFrame: 16 weeks
measure: Physical Activity Adherence Assessment- length of wear.
timeFrame: 16 weeks
measure: Determination of LA County Facilities Health Care Use- number of inpatient LA County Hospital visits
timeFrame: 16 weeks
measure: Determination of LA County Facilities Health Care Use- number of LA County Hospital Outpatient visits
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of Life (QOL) Assessment
timeFrame: At Baseline Visit and Week 16
measure: Spanish Acculturation
timeFrame: At Baseline
measure: Brief Illness Perception Questionnaire (BIPQ)
timeFrame: At Baseline and Week 16
measure: Spanish Physical Activity Questionnaire
timeFrame: At Baseline and Week 16
measure: FitBit Wear Technology Questionnaire
timeFrame: At Week 16
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Giselle Petzinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garbin A, Diaz J, Bui V, Morrison J, Fisher BE, Palacios C, Estrada-Darley I, Haase D, Wing D, Amezcua L, Jakowec MW, Kaplan C, Petzinger G. Promoting Physical Activity in a Spanish-Speaking Latina Population of Low Socioeconomic Status With Chronic Neurological Disorders: Proof-of-Concept Study. JMIR Form Res. 2022 Apr 20;6(4):e34312. doi: 10.2196/34312.