NCT03191630

Brief Summary

Inactivity is a common problem among older kidney transplant recipients (KTRs) and is associated with their high incidence of obesity and cardiovascular problems which are the leading cause of death for KTRs. However, the combination of SystemCHANGE activity trackers holds promise for increasing physical activity of KTR patients post-surgery. This pilot study will incorporate Fitbit health trackers with an intervention of questions about influences to physical activity in a population of kidney transplant recipients who are at particularly high risk of cardiovascular disease and death.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 23, 2021

Completed
Last Updated

March 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2.6 years

First QC Date

June 13, 2017

Results QC Date

August 25, 2020

Last Update Submit

February 26, 2021

Conditions

Kidney Transplant; ComplicationsPhysical ActivityCardiorenal; ChangeCardiovascular Diseases

Keywords

Kidney transplantSystemCHANGEphysical activitysmart phoneFitbitactivity monitorstep countpost-surgeryquality of lifecardiovascular

Outcome Measures

Primary Outcomes (1)

  • Steps Taken Per Day by Using an Activity Tracker

    Steps were averaged per day.

    (T2) 3months, (T3) 6months, & (T4)12 months

Secondary Outcomes (7)

  • Six Minute Walk Test

    (T2) 3months, (T3) 6months, & (T4)12 months

  • Resting Blood Pressure

    (T2) 3months, (T3) 6months, & (T4)12 months

  • Quality of Life: Physical (Functional) and Mental (Well-being) Health"

    (T2) 3months, (T3) 6months, & (T4)12 months

  • Weight (Pounds)

    (T2) 3months, (T3) 6months, & (T4)12 months

  • Radial Pulse (Beats Per Minute)

    (T2) 3months, (T3) 6months, & (T4)12 months

  • +2 more secondary outcomes

Study Arms (2)

Control

EXPERIMENTAL

This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.

Behavioral: Fitbit (Control)

Intervention

EXPERIMENTAL

This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE TM and activity tracker intervention

Behavioral: SystemCHANGE and Fitbit (Intervention)

Interventions

Fitbit (Control)BEHAVIORAL

Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.

Also known as: Fitbit
Control
SystemCHANGE and Fitbit (Intervention)BEHAVIORAL

Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. Participants will continue for months, after which time there will be a final group session.

Also known as: SystemCHANGE and Fitbit
Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney transplant recipient at The Ohio State University Wexner Medical Center, Kidney Transplant Program
  • Age 60 or older
  • Received clearance from healthcare provider to participate
  • Ability to speak, read, and hear English
  • Possession or ready-access to a smart phone capable of accessing mobile activity tracker data
  • Lacks cognitive impairment (verified by mini cognition test)
  • Able to walk without an assist device (cane or walker)
  • Not currently hospitalized
  • Greater than 3 months post- transplant

You may not qualify if:

  • Currently on dialysis
  • Currently participating in a weight loss program
  • Currently participating in a structured exercise program
  • Currently wearing/using an activity tracker
  • Planning to relocate out of the Columbus area in the next 6 months or less

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center, Kidney Transplant Program

Columbus, Ohio, 43214, United States

Location

Related Publications (2)

  • O'Brien T, Russell CL, Tan A, Mion L, Rose K, Focht B, Daloul R, Hathaway D. A Pilot Randomized Controlled Trial Using SystemCHANGE Approach to Increase Physical Activity in Older Kidney Transplant Recipients. Prog Transplant. 2020 Dec;30(4):306-314. doi: 10.1177/1526924820958148. Epub 2020 Sep 10.

    PMID: 32912051DERIVED

  • O'Brien T, Russell CL, AlKahlout N, Rosenthal A, Meyer T, Tan A, Daloul R, Hathaway D. Recruitment of Older Kidney Transplant Recipients to a Longitudinal Study. Nurs Res. 2020 May/Jun;69(3):233-237. doi: 10.1097/NNR.0000000000000406.

    PMID: 31688340DERIVED

MeSH Terms

Conditions

Motor ActivityCardiovascular Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Dr. Tara O'Brien
Organization
The Ohio State University
obrien.782@osu.edu
6142928045

Study Officials

  • Tara O'Brien, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants in the intervention group will receive the combination of the SystemCHANGE and activity tracker intervention while participants in the control group will use activity trackers only. Intervention and control groups will receive the same instruction on use of the activity tracker, and have the same number of study contacts.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 19, 2017

Study Start

October 1, 2017

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

March 23, 2021

Results First Posted

March 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)