Kidney Transplant, Liver Transplant
Conditions
Brief summary
The objective of this study is to evaluate the feasibility of the MoveMend Health software program as an integrated supplement to traditional acute care/in-hospital occupational therapy for patients following liver and kidney transplants, as determined by recruitment rates, program completion, intervention adherence, safety incidence, and patient feedback on device/program performance.
Interventions
DEVICEMoveMend Health
Software-based therapeutic tool that offers gamified exercises and activities. The device is designed for deployment on tablets. The core purpose of the device is to augment patient engagement and participation in their own rehabilitation by providing additional therapeutic interventions between formal occupational therapy sessions.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speaking (software program is currently only available in English) * Status post kidney or liver transplant this admission * Physician orders for occupational therapy evaluation and treatment * Orientation Log \> 25 * Negative for delirium per the Confusion Assessment Method
Exclusion criteria
* Orthopedic or surgical precautions that limits shoulder range of motion beyond 90 degrees * Upper extremity hemiplegia with inability to lift upper extremity against gravity * Accommodation code of Intensive Care Unit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | Up to Month 6 Post-Operation | Measured using data from participant's electronic medical record. |
| Recruitment Rate | Up to Month 6 Post-Operation | Calculated by dividing the number of participants enrolled by the total number of patients contacted or screened. |
| Percentage of Participants who Complete Exercise Program | Up to Month 6 Post-Operation | Percentage of enrolled participants who complete the interventional program. |
| Percentage of Participants who Adhere to Intervention | Up to Month 6 Post-Operation | Measured by session duration and frequency, as recorded by the device. Participants will be classified as adhering or not adhering. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Activity Measure for Post-Acute Care (AMPAC) Score | Baseline, End of Hospital Stay (typically no more than 6 months post-operation) | 12-item assessment of basic mobility of inpatients. Each item is rated on a Likert scale from 1-4. The raw score is the sum of responses, which is converted to a T-score. The total score is a T-score ranging from 0 to 100; higher scores indicate greater mobility. |
| Change in Grip Strength | Baseline, End of Hospital Stay (typically no more than 6 months post-operation) | Measured as the percentage change in grip strength between the baseline assessment and the final assessment at discharge. |
| Upper Extremity Range of Motion (ROM) Change | Baseline, End of Hospital Stay (typically no more than 6 months post-operation) | Measured as the change in degrees of ROM at the shoulder and elbow as measured by a goniometer from baseline to discharge. |
| Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score | Baseline, End of Hospital Stay (typically no more than 6 months post-operation) | The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction. |
Countries
United States
Outcome results
None listed