NCT04405635

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 30, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

4.2 years

First QC Date

May 26, 2020

Last Update Submit

December 6, 2023

Conditions

Keywords

Stroke, digital behavior, health-related quality of life, cognitive function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • EQ5D

    Once a week during 12 weeks

  • Mini MoCA

    3 times in three months, after 4, 8 and 12 weeks

  • SF-36

    3 times in three months, after 4, 8 and 12 weeks

  • Stroke Specific Quality of Life Questionnaire - short version

    3 times in three months, after 4, 8 and 12 weeks

Other Outcomes (1)

  • Health today

    Every day throughout 90 days

Interventions

No intervention or exposure

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Aarhus, 8450, Denmark

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Iris C. Brunner, PhD

    Aarhus University, Hammel Neurocenter

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Brunner, PhD

CONTACT

Jørgen Feldbæk Nielsen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 28, 2020

Study Start

May 30, 2020

Primary Completion

July 28, 2024

Study Completion

August 30, 2024

Last Updated

December 7, 2023

Record last verified: 2023-12

Locations