Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors

Stroke Clinical Trial

— QuantStroke  

Official title:

Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405635
• Other study ID #: 614731
• Status: Recruiting
• Start date: May 30, 2020
• Est. completion date: August 30, 2024

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: Iris Brunner, PhD
• Phone: +4560568195
• Email: Iris.Brunner[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• No intervention or exposure
No intervention or exposure

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation Centre and University Research Clinic	Hammel	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Carlsberg Foundation, Leiden University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health today	One question about subjective health, VAS 0-100 (better)	Every day throughout 90 days
Primary	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	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
Secondary	Mini MoCA	Montreal Cognitive Assessment, cognitive function, scale 0-15 (better)	3 times in three months, after 4, 8 and 12 weeks
Secondary	SF-36	Health related quality of life, 0-100 (better)	3 times in three months, after 4, 8 and 12 weeks
Secondary	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