Activity Therapy After Kidney Transplant

Activity Therapy After Kidney Transplant: A Pilot Study

To combat post-transplant weight gain, we seek to expand Stanford Kidney Transplant's multidisciplinary platform to include physical activity monitoring and coaching using the Apple Watch.

Study Overview

• Status: Terminated
• Conditions: Kidney Transplant; Complications
• Intervention / Treatment: Device: Apple Watch Series 1

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Hospital and Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All adults (18 years) who undergo kidney transplant at Stanford.

Exclusion Criteria:

• Poor vision with inability to use Apple Watch
• Permanently unable to ambulate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apple Watch; Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months.	Device: Apple Watch Series 1; Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months.
No Intervention: Usual Care; Usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activity Level (daily caloric consumption)	1 year
% Days using Apple Watch	1st year of transplant

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight	1st year of transplant
Hemoglobin A1c	1st year of transplant

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Apple Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 44663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No