Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
English reading/speaking
Are status post low-energy hip fracture, total knee/hip arthroplasty, or single to multilevel spinal fusion without paralysis
Disqualifiers
Severe cognitive impairment: Not alert and oriented to person, place, time, and reason for being the hospital; and unable to follow 2 step commands
Neurologic paralysis
Polytraumas with restrictions incompatible with anti-gravity exercises
Knee immobilization, bed rest
Trial design
Design model
Parallel
Treatments tested in this trial
App for in-bed conditioning exercises
DeviceParticipants will use an application (app) in facilitating in-bed conditioning exercises for hospitalized patients
Usual care
Other interventionAll participants will receive usual care in the post-operative setting.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Enhanced CareExperimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in patient performance during physical therapy (PT)
Patient performance during physical therapy will be assessed using The Activity Measure for Post-Acute Care (AMPAC). The AMPAC score is a comprehensive assessment tool used to evaluate a patient's functional abilities in various domains, including mobility, daily activities, and social interaction. Total score range from 6-24 with higher scores indicating the participant is able to independently perform all activities.
Time frame
Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)Secondary outcomes
1
Patient-reported satisfaction metrics
Patients will be surveyed at the end of their intervention using 18 Likert scale (1 to 10), with 10 questions pertaining to their patient care experience, and 8 questions pertaining to their experience using the StrongRx tool. Survey will be piloted to ensure feasibility and ease of completion. Total score range 18-180 with higher scores indicating higher satisfaction.
Time frame
at postoperative day 3-52
Length of stay
Length of hospital stay serves as a secondary outcome to assess the impact of the intervention on healthcare resource utilization and patient recovery. A shorter length of stay may indicate improved outcomes and efficiency of care delivery, potentially resulting from enhanced rehabilitation efforts facilitated by the tool.
Time frame
an average of 3-5 days3
Postoperative VAS scores
Pain management is a critical aspect of postoperative care, and VAS scores provide a reliable measure of patients' subjective pain levels. Scores will range from 0 (No Pain) to 10 (Worse Pain Possible), with emotion icons to help patients identify which pain level most closely corresponds to their current level. Higher scores indicating more pain.
Time frame
immediately postoperative and day of last admission, up to 5 days4
Patient performance on the app
Evaluation of patient performance on the StrongRx app includes tracking points obtained, levels achieved, and exercise sets completed per day. Number of sets completed for each exercise will accrue 1 point for the patient. There will be 3 levels of ease that that will be user directed based on whether the patient is able to easily complete the set. For each level obtained, the points will get a multiplier (1x, 2x, 3x), which corresponds to the multiple of increased repetitions of the exercise. Higher scores indicate more exercises completed.
Time frame
an average of 3-5 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov