Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03191630 |
| Other study ID # |
2017B0084 |
| Secondary ID |
1K23NR016274-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2017 |
| Est. completion date |
April 30, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
