Increasing Activity Post-Kidney Transplant With SystemCHANGE

NCT ID: NCT03191630

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-04-30

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.

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.

Conditions

Kidney Transplant; Complications; Physical Activity; Cardiorenal; Change; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: EXPERIMENTAL

Fitbit (Control)

Intervention Type: 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.

Intervention

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

Group Type: EXPERIMENTAL

SystemCHANGE and Fitbit (Intervention)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Fitbit; SystemCHANGE and Fitbit

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tara O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center, Kidney Transplant Program

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32912051 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31688340 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K23NR016274-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017B0084

Identifier Type: -

Identifier Source: org_study_id