StrokeQuantStrokeNCT04405635
Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors
An observational study of Stroke, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 30 May 2020to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- New or recurrent stroke, admitted to rehabilitation, discharge to own home
- Owns an Android smart phone
- Smart phone is used by the patient only
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jørgen Feldbæk Nielsen, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Aarhus, 8450
Iris Brunner, PhD, +4560568195, Iris.Brunner@rm.dk
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- No intervention or exposure
- Keywords
- Stroke, digital behavior, health-related quality of life, cognitive function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention or exposureOther
No intervention or exposure
What is being measured
The primary outcome is the main question the study is designed to answer.
Different parameters of digital behavior
Number of interactions with the smart phone, tapping speed, typing speed, social media use
Measured: Continuously throughout the 90 days of monitoring
Secondary outcomes (4)
EQ5D
Health related quality of life, 5 point subscale, Index values of 0-1 (better), EQ5D VAS 0-100 (better)
Measured: Once a week during 12 weeks
Mini MoCA
Montreal Cognitive Assessment, cognitive function, scale 0-15 (better)
Measured: 3 times in three months, after 4, 8 and 12 weeks
SF-36
Health related quality of life, 0-100 (better)
Measured: 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)
Measured: 3 times in three months, after 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start30 May 2020
- Primary completion28 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University, Carlsberg Foundation
- Responsible party
- Sponsor
- Investigators
- Iris C. Brunner, PhD, Principal investigator, Aarhus University, Hammel Neurocenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405635
- Sponsor's protocol ID
- 614731
- Acronym
- QuantStroke
- Status last verified
- Dec 2023
- First submitted
- 26 May 2020
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Processed smartphone behavioral data and the associated processing codes will be made available upon publication and corresponding release in data repositories.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors
- ClinicalTrials.gov ID
- NCT04405635
- Acronym / sponsor ID
- QuantStroke / 614731
- Conditions
- Stroke
- Keywords
- Stroke, digital behavior, health-related quality of life, cognitive function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Leiden University, Carlsberg Foundation
- Study start
- 30 May 2020 (actual)
- Primary completion
- 28 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- New or recurrent stroke, admitted to rehabilitation, discharge to own home
- Owns an Android smart phone
- Smart phone is used by the patient only
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention or exposureNo intervention or exposure | Other | – |
Primary outcome
Different parameters of digital behavior
Time frame: Continuously throughout the 90 days of monitoring
Number of interactions with the smart phone, tapping speed, typing speed, social media use
4 secondary outcomes
EQ5D
Time frame: Once a week during 12 weeks
Mini MoCA
Time frame: 3 times in three months, after 4, 8 and 12 weeks
SF-36
Time frame: 3 times in three months, after 4, 8 and 12 weeks
Stroke Specific Quality of Life Questionnaire - short version
Time frame: 3 times in three months, after 4, 8 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided. Processed smartphone behavioral data and the associated processing codes will be made available upon publication and corresponding release in data repositories.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørgen Feldbæk Nielsen, PhD contact
Iris C. Brunner, PhD principal investigator
Aarhus University, Hammel Neurocenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris Brunner, PhD (+4560568195, Iris.Brunner@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Different parameters of digital behavior (time frame: Continuously throughout the 90 days of monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.