Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors

Recruiting

• Conditions: Stroke

• Registration Number: NCT04405635
• Lead Sponsor: University of Aarhus

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Study Start: 2020-05-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-07-28
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hammel Neurorehabilitation Centre and University Research Clinic; 🇩🇰 Hammel, Aarhus, Denmark