Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors (QuantStroke)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: No intervention or exposure

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Iris Brunner, PhD; Phone Number: +4560568195; Email: Iris.Brunner@rm.dk
• Study Contact Backup: Name: Jørgen Feldbæk Nielsen, PhD

Study Locations

• Denmark
  • Aarhus
    • Hammel, Aarhus, Denmark, 8450
      • Recruiting
      • Hammel neurorehabilitation centre and university research clinic
      • Contact: Iris Brunner, PhD; Phone Number: +4560568195; Email: Iris.Brunner@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Different parameters of digital behavior	Number of interactions with the smart phone, tapping speed, typing speed, social media use	Continuously throughout the 90 days of monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D	Health related quality of life, 5 point subscale, Index values of 0-1 (better), EQ5D VAS 0-100 (better)	Once a week during 12 weeks
Mini MoCA	Montreal Cognitive Assessment, cognitive function, scale 0-15 (better)	3 times in three months, after 4, 8 and 12 weeks
SF-36	Health related quality of life, 0-100 (better)	3 times in three months, after 4, 8 and 12 weeks
Stroke Specific Quality of Life Questionnaire - short version	Stroke related quality of life, 12-60 (better)	3 times in three months, after 4, 8 and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health today	One question about subjective health, VAS 0-100 (better)	Every day throughout 90 days

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Leiden University; Carlsberg Foundation
• Investigators: Principal Investigator: Iris C. Brunner, PhD, Aarhus University, Hammel Neurocenter

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2020
• Primary Completion (Estimated): July 28, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Stroke, digital behavior, health-related quality of life, cognitive function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 614731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Processed smartphone behavioral data and the associated processing codes will be made available upon publication and corresponding release in data repositories.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No