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Completed

NCT Number: NCT06825988

The Use of the GRASP System for Postoperative Monitoring

The aim of this study is to explore feasibility and user experience of a novel digital system containing a handheld electronic device and a mobile application - called Grasp - in the setting of postoperative monitoring of pain and patient reported outcome measures in knee arthroplasty patients.

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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Key information

Conditions

Knee Arthroplasty, Total Rehabilitation

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Helse Bergen

Bergen, 5021, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective joint arthroplasty
  • Age: 30-70 years
  • Must own and be able to use a smart phone
  • Speak and understand Norwegian

Exclusion criteria

  • Not able to give informed consent

Treatment and study plan

Grasp

Device

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.

Primary outcomes

  1. Feasibility of the intervention study

    Time frame: From enrollment to 6 weeks after surgery

    Feasibility of the intervention study will be evalutated through adhererance to intervention protocol. It will be assessed as number of patients who are able to do as instructed in the protocol. Fidilty >80% will be considered high, 50-80% moderate, and <50% low. The investigators expect a priori the adherance to protocol guidelines to decline during the 6 weeks intervention period

  2. User experience

    Time frame: From enrollment to 6 weeks post surgery

    Mixed methods approach will be used to evaluate user experience. The investigators will make a mixed methods synthsis between participants questionnaires (by 2 and 6 weeks of intervention) and semi-structured interviews of up to 10 participants and associated physiotherapists by the end of the intervention period.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Grasp AS
  • University of Bergen

Registry information

Official study title

The Use of the GRASP System for Postoperative Monitoring - a Feasibility Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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