NCT03426280

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

February 2, 2018

Last Update Submit

June 23, 2023

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (2)

  • Activity Level (daily caloric consumption)

    1 year

  • % Days using Apple Watch

    1st year of transplant

Secondary Outcomes (2)

  • Weight

    1st year of transplant

  • Hemoglobin A1c

    1st year of transplant

Study Arms (2)

Apple Watch

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Usual care.

Interventions

Apple Watch Series 1DEVICE

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.

Apple Watch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital and Clinic

Palo Alto, California, 94304, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 8, 2018

Study Start

May 1, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)