Increasing Activity Post-Kidney Transplant With SystemCHANGE (CHANGE)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Physical Activity; Kidney Transplant; Complications; Cardiorenal; Change
• Intervention / Treatment: Behavioral: Fitbit (Control); Behavioral: SystemCHANGE and Fitbit (Intervention)

Detailed Description

This is a randomized study with intervention and control arms of sixty kidney transplant recipients age 60 and older. Demographic information will be collected during the screening phone call and will include: gender, race, marital status, income, education, transplant date, prescribed medications, type of diet, smoking status, and co-morbidities. All study data will be entered directly into electronic research forms using REDCap.

Overview of Intervention and Control Groups:

Intervention and control groups will be enrolled in the study in the same manner, receive the same instruction on use of the Fitbit and have the same number of study contacts. Group sessions will be held 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.

Intervention Group Active Phase, Group Session 1 (1 hour, 20 minutes): Research staff will demonstrate proper Fitbit activity tracker use, set up the smartphone application, and assist entry of daily step goals into the smartphone application. Fitbits will be set up with Gmail accounts with unique unidentifiable codes. Participants will be taught how to sync to their smartphone and retrieve data from their Fitbit. One week following this session, participants will be called to troubleshoot problems and be encourage to increase their step goal 5% each month (total phone time 15 minutes).

Intervention/Control Group Timeline:

Intervention Active Phase, Group Session 2 (1 hour): Fitbit activity tracker reports will be reviewed by research staff with participants. SystemCHANGE concepts will be discussed such as "opportunities for improvement" and "possibilities for doing better."

A SystemCHANGE powerpoint will outline components and participants will be placed in groups of 5 where researchers will guide participants through the 4 steps of SystemCHANGE.

Participants will be asked to identify important people that influence their physical activity, which habits or activity occur daily, weekly, or monthly, and how these habits and people impact physical activity. Participants will also include things that influence their participation in physical activity (e.g., availability of facilities as a walking path getting home from work late, or sleeping late on a weekend). Social activities and any rituals associated with physical activity such as gardening, housecleaning, shopping, and hobbies will also be noted. Research staff will place the routines (daily, weekly, monthly) into a graphic format that helps participants understand how routines are related to each other and can work for, or against, changing physical activity behavior. These cycles will be discussed to help understanding of how a routine involving family demands, for example, may influence participation in physical activity. Goals for increasing steps will be made, (generally, a 5% increase) and use of their activity tracker reports for monitoring progress toward improvement will be discussed and demonstrated. In this session and throughout, participants will be encouraged to look beyond personal motivation and explore their life routines and the people who shape those routines.

Intervention Active Phase, Group Sessions 3-7 (1 hour/session): Prior to each session, the participants' activity tracker reports will be given to them and reviewed during the group session. Participants will be asked what they are learning about their physical activity and what changes they want to make. Participants will be asked to describe their improvements and be encouraged to continue using the activity tracker for the next 6 months during the maintenance phase.

Intervention Maintenance (6 months): At the final monthly session, participants will be instructed to continue until month 12.

Control Group 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 5% each month based on the step-data received from baseline to week 1.

Session 2 will be used to troubleshoot and discuss any problems with the Fitbit activity trackers. In later sessions, educational information about healthy living as a transplant recipient will be presented, including topics such as diet, taking medication, risk for skin cancer, gastrointestinal side effects, dental care, and new onset post-transplant diabetes. The meeting time will be equivalent to those of the intervention group

The maintenance phase will last 6 months. At month 7, just as the intervention group, participants will be reminded to continue their use of the Fitbit activity tracker and that the research team will not be in contact with them for 6 months. There will be a final meeting at month 12.

Study staff will provide assistance as needed by reading questions to participants. Outcome data from both study groups will be collected at the appropriate sessions.

Retention: Text messages will be sent to participants during months when they are not attending a face-to-face session to provide encouragement and reinforcement for their participation in the study. In addition, phone calls will be made by research staff during each month to each participant to provide updates on their progress in the study as well as encouragement and support. Participants who complete the study will be allowed to keep their activity tracker.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43214
      • The Ohio State University Wexner Medical Center, Kidney Transplant Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; 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); 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.; Other Names: Fitbit
Experimental: Intervention; 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); 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.; Other Names: SystemCHANGE and Fitbit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steps Taken Per Day by Using an Activity Tracker	Steps were averaged per day.	(T2) 3months, (T3) 6months, & (T4)12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Test	A section of 98 feet was marked off on a hard flat surface using two orange cones. Participants were asked to walk at a comfortable pace for 6-minutes between the cones while being timed, and the distance walked was recorded in feet.	(T2) 3months, (T3) 6months, & (T4)12 months
Resting Blood Pressure	Resting blood pressure will be measured on each participant in a seated position using a Withings blood pressure cuff by the research staff. The research staff collecting the resting blood pressure reading will be a registered nurse. The research staff collecting the readings will be blinded to the study groups.	(T2) 3months, (T3) 6months, & (T4)12 months
Quality of Life: Physical (Functional) and Mental (Well-being) Health"	Physical and mental component scores, ranging from 0 (lowest level of health) to 100 (highest level of health), are derived from the individual items and was used as study outcomes.	(T2) 3months, (T3) 6months, & (T4)12 months
Weight (Pounds)	Weight was measured without shoes and in light clothing using a digital scale.	(T2) 3months, (T3) 6months, & (T4)12 months
Radial Pulse (Beats Per Minute)	The research staff will obtain a radial pulse (heart rate) over a 60-second count while the participant remains seated. The research staff collecting the radial pulse reading will be a registered nurse and blinded to the study groups.	(T2) 3months, (T3) 6months, & (T4)12 months
Body Mass Index (BMI)kg/m2	Body mass index (BMI; kg/m2) will be calculated as [mass (lb)/ height (in)2 x 703	(T2) 3months, (T3) 6months, & (T4)12 months
Health Outcome: Waist Circumference (cm)	Waist circumference (WC) will be obtained by measuring the individual's circumference halfway between the illac crest and the lower anterior ribs with the person standing upright during expiration.	(T2) 3months, (T3) 6months, & (T4)12 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Tara O'Brien, PhD, Ohio State University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; quality of life; Kidney transplant; cardiovascular; activity monitor; Fitbit; post-surgery; smart phone; step count; SystemCHANGE
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2017B0084; 1K23NR016274-01A1 (U.S. NIH Grant/Contract)

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