The Use of the GRASP System for Postoperative Monitoring
NCT ID: NCT06825988
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
36 participants
INTERVENTIONAL
2023-11-01
2024-07-31
Brief Summary
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The investigators will use a mixed-methods approach to gain in-depth insights into feasibility and user experience of this system in order to evaluate further improvement needs of both study design and intervention before a final randomised effect study. Feasibility will be evalutated through recruittment rates, adhererance to intervention protocol and study data sampling, and completion rates. Fidelity will be assessed as number of patients who are able to do as instructed in the protocol. In addition, the investigators will explore user experience through questionnaires after 2 and 6 weeks of use and through semi-structered interviews of participants and associated physiotherapists. Interviews will be transcribed for qualitative analyses.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Grasp system
Grasp system (hardware and mobile application) during first 6 postsurgical weeks of rehabilitation. Subjects are instructed to report pain through squeezing the hardware in 3 different levels regulaly during the day, and, in addition enter answers to questions on patient reported outcome meassures (sleep quality, overall well-being, use of medication, appetit, physical activity) and register exercise time into the mobile application. Data entries will be presented as trajectories in graphs and charts in the app. At their 6 weeks physiotherapist consult, the physiotherapists will use the data during the consult.
Grasp
Grasp system (hardware and mobile application) during first 6 postsurgical weeks of rehabilitation. Subjects are instructed to report pain through squeezing the hardware in 3 different levels regulaly during the day, and, in addition enter answers to questions on patient reported outcome meassures (sleep quality, overall well-being, use of medication, appetit, physical activity) and register exercise time into the mobile application.
Interventions
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Grasp
Grasp system (hardware and mobile application) during first 6 postsurgical weeks of rehabilitation. Subjects are instructed to report pain through squeezing the hardware in 3 different levels regulaly during the day, and, in addition enter answers to questions on patient reported outcome meassures (sleep quality, overall well-being, use of medication, appetit, physical activity) and register exercise time into the mobile application.
Eligibility Criteria
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Inclusion Criteria
* Age: 30-70 years
* Must own and be able to use a smart phone
* Speak and understand Norwegian
Exclusion Criteria
30 Years
70 Years
ALL
No
Sponsors
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University of Bergen
OTHER
Grasp AS
UNKNOWN
Haukeland University Hospital
OTHER
Responsible Party
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Locations
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Helse Bergen
Bergen, , Norway
Countries
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Other Identifiers
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Pilot Helse
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
634183
Identifier Type: -
Identifier Source: org_study_id
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