Clinical trial NCT04592627: Facial and Body Motion Technology and Stroke
Official title: Facial and Body Motion Technology to Detect Psychosocial Distress in Stroke Survivors and Informal Caregivers Living at Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
caregiver
technology
psychosocial
aging
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 6 post-stroke survivor-informal caregiver dyads recruited from the UT Physicians Stroke Outpatient Clinic for a total of 12 study participants (6 stroke survivors and 6 informal caregivers of stroke survivors).

Brief summary: The purpose of this study is to customize privacy protected facial expression and body motion tracking for use in the home environment by stroke survivor-informal caregiver dyads by investigating within a simulated home environment, background variability,possible occlusions, privacy considerations, and the motor weaknesses, gait impairments, and facial expressions of stroke survivors and to determine the acceptability of the customized facial expression and body motion technology in stroke survivors and their informal caregivers.

Detailed description: Stroke is a leading cause of disability. Most stroke survivors are discharged home after hospitalization and receive care from informal caregivers (e.g., unpaid spouses) who are often unprepared for the role. Stroke survivorship is an exemplar of a chronic condition that detracts from the affected individual and caregiver's capacity to live well within the home (e.g., psychosocial distress). Early identification of psychosocial distress is likely to lead to timely interventions and, subsequently, decreases in associated morbidity, mortality, and disability. Yet, only a minority of survivors are properly identified and treated for psychosocial distress, and caregivers are primarily forgotten. In-home, objective measures to identify psychosocial distress are lacking. Using facial expression and body motion technology by extracting facial characteristics and body joints (skeletal graph) known to be associated with psychosocial distress (e.g., frowning) provides new opportunities to support in-home telemonitoring. To accommodate real-world, post-stroke home environments, the technology needs to be customized to an in-home environment. Toward this end, the investigators must consider background variability, possible occlusions, privacy concerns, and stroke survivor motor weaknesses, gait impairments, and facial paralysis. Objectives: The primary objectives are to customize facial expression and body motion technology and examine the acceptability of the technology through a study of 6 stroke survivor-informal caregiver dyads within a simulated home environment. The project will serve as a necessary step to amass critical information to design future trials using facial expression and body motion technology. The ultimate goal is to improve psychosocial well-being for those aging at home.

Eligibility criteria: Inclusion Criteria:

* can read, write, and speak English
* are willing and able to provide informed consent
* Informal caregivers must live in the home with the stroke survivor and be unpaid for their role
* Stroke survivors must have some degree of facial and limb weakness and a Modified Rankin Scale (mRS)13 score between 1 and 3.

Exclusion Criteria:

- stroke survivors currently reside outside of the home and are wheelchair bound.

Primary outcomes:
measure: Accuracy of the technology
timeFrame: During the procedure known as the simulated home environment visit
measure: Sensitivity of the technology
timeFrame: During the procedure known as the simulated home environment visit
measure: Specificity of the technology
timeFrame: During the procedure known as the simulated home environment visit
Secondary outcomes:
measure: Acceptability as measured by the patient satisfaction survey
timeFrame: Immediately after the procedure known as the stimulated home environment visit
measure: Acceptability as measured by the open ended interview
timeFrame: Immediately after the procedure known as the stimulated home environment visit
measure: Acceptability as measured by field observations
timeFrame: During and immediately after the procedure known as the stimulated home environment visit
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jennifer E Beauchamp, PhD,RN,FAAN
role: PRINCIPAL_INVESTIGATOR
References: