Clinical trial NCT04405635: Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors
Official title: Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Stroke, digital behavior, health-related quality of life, cognitive function
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Leiden University
name: Carlsberg Foundation
First posted: 2020-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We want to include a broad range of patients with stroke, incuding both ischemic and hemorrhagic strokes and different impairments due to stroke. Patients are recruited at two wards specialized in neurorehabilitation around 1 week before discharge to their home.

Brief summary: In this study, we want to continuously record the interaction of 50 stroke survivors with their smartphones during the first 3 months after discharge. The linkage of smart phone use to function and quality of life will be assessed with standardized outcome measures at defined time points.

Detailed description: People with stroke are among the most relevant target groups for unobtrusive monitoring. Worldwide, stroke is the second most frequent cause for lasting disability and causes a substantial burden for the individual, caregivers and society. Thanks to improved treatment, many stroke survivors can be discharged to their homes. However, many have to live with disabilities and are prone to declining function, cognitive impairment and depression. With the acquired data, we want to create a database where digital behavior is analyzed with advanced computational methods. In collaboration with the Department of Cognitive Psychology, University of Leiden, Netherlands, these data will be used to discover specific features for different health issues and to develop tools for the early detection of functional decline for different populations.

Eligibility criteria: Inclusion Criteria:

* New or recurrent stroke, admitted to rehabilitation, discharge to own home
* Owns an Android smart phone
* Smart phone is used by the patient only

Exclusion Criteria:

* Severe cognitive impairments and / or psychiatric and behavioral conditions that interfere with compliance.
* Not able to provide informed consent
* Discharge to nursing homes or other care facilities

Primary outcomes:
measure: Different parameters of digital behavior
timeFrame: Continuously throughout the 90 days of monitoring
Secondary outcomes:
measure: EQ5D
timeFrame: Once a week during 12 weeks
measure: Mini MoCA
timeFrame: 3 times in three months, after 4, 8 and 12 weeks
measure: SF-36
timeFrame: 3 times in three months, after 4, 8 and 12 weeks
measure: Stroke Specific Quality of Life Questionnaire - short version
timeFrame: 3 times in three months, after 4, 8 and 12 weeks
Other outcomes:
measure: Health today
timeFrame: Every day throughout 90 days
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation Centre and University Research Clinic
state: Aarhus
Study officials:
affiliation: Aarhus University, Hammel Neurocenter
name: Iris C. Brunner, PhD
role: PRINCIPAL_INVESTIGATOR
References: