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The wEight Management in Renal Transplant Online Study (ExeRTiOn) (ExeRTiOn)

Primary Purpose

Kidney Transplant; Complications, Obesity, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ExeRTiOn
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplant; Complications focused on measuring Kidney transplant, Weight gain, Physical activity, Weight management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Eligibility criteria for the Kidney Transplant Participants (n=10)

Inclusion Criteria:

  • adult patients (18years+)
  • Male or female
  • Written informed consent
  • < 3 months post kidney transplant
  • access to internet connected computer, smart-phone or tablet
  • A Body Mass Index (BMI) greater than or equal to 18.5 (healthy range)

Exclusion Criteria:

  • pregnancy
  • Unstable medical conditions such as; angina, uncontrolled hypertension or diabetes, congestive cardiac failure, active myocarditis/ pericarditis, cardiac arrhythmia, co-morbid catabolic conditions, psychiatric illness.
  • Participated in a structured exercise or physical activity intervention in the last three months.
  • BMI of less than 18.5 (classified as underweight)
  • significant cognitive impairment preventing them from engaging with online interactive material

Eligibility criteria for the Transplant Health Care Professionals (n=5)

Inclusion criteria:

  • A nephrologist, kidney doctor, nurse or member of the multi-disciplinary team who actively work with kidney transplant patients at King's College Hospital
  • Adult above 18 years of age
  • Able to provide written consent
  • Access to Internet connected computer, smart-phone or tablet.

Exclusion criteria:

  • Pregnancy
  • Unstable medical conditions such as angina, uncontrolled hypertension or diabetes, congestive cardiac failure, active myocarditis, cardiac arrhythmia, co-morbid catabolic condition, psychiatric illness.

Sites / Locations

  • King's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Health Care Professionals

Kidney Transplant Patients

Arm Description

A purposeful sample of 5 HCP's from the transplant team will test the online intervention and be interviewed using qualitative methods. This data will be analysed and used to plan a second study (feasibility RCT).

A purposeful sample of 10 kidney transplant patients will test the online intervention and be interviewed using qualitative methods. This data will be analysed and used to plan a second study (feasibility RCT).

Outcomes

Primary Outcome Measures

Patient experience and learning using the "ExeRTiOn" online resource
Patient experience and learning using the "ExeRTiOn" online resource determined by qualitative interview

Secondary Outcome Measures

Transplant health care professional experience and knowledge reviewing the online resource
Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview
Any difficulties/ barriers to participating in the study
Any difficulties/ barriers to participating in the study determined by a qualitative interivew
Any difficulties/ barriers to using the "ExeRTiOn" resource
Any difficulties/ barriers to using the "ExeRTiOn" resource determined by a qualitative interview
Components of the "ExeRTiOn" resource that are helpful/ unhelpful
Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview
Weakness of the "ExeRTiOn" resource
Weakness of the "ExeRTiOn" resource determined by a qualitative interview
Strengths of the "ExeRTiOn" resource
Strengths of the "ExeRTiOn" resource determined by a qualitative interview
feasibility and use of the ExeRTiOn resource
log in time for the study visit and time using the resource will be recorded by the online resource
feasibility outcome (adherence)
adherence to study visits
height
measured in centimeters
weight
measured in kilograms
Body mass index (BMI)
weight and height will be combined to report BMI in kg/m2
descriptive data
descriptive data including gender, date of transplant and age

Full Information

First Posted
August 8, 2018
Last Updated
September 11, 2019
Sponsor
King's College Hospital NHS Trust
Collaborators
Kidney Research U.K.
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1. Study Identification

Unique Protocol Identification Number
NCT03699059
Brief Title
The wEight Management in Renal Transplant Online Study (ExeRTiOn)
Acronym
ExeRTiOn
Official Title
A Study to Assess the Acceptability of an Online Weight Prevention Programme for New Kidney Transplant Recipients- The WEight Management in Renal Transplant Online Study (ExeRTiOn)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
Kidney Research U.K.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary aim of this project is to create an online weight management tool (Physical activity, weight management and cognitive behavioral therapy) to prevent significant weight gain following kidney transplantation. Designing the online interactive weight management resource for kidney transplant patients will involve patient and health care professional input through Qualitative methodology such as 'Think-Aloud' interviews and one-to-one semi-structured interviews. This online resource will be called "exertion" and will be created by the research team, with technical support from the Software Company (SPIKA). Results from this study will refine the resource, and lead to a study application for a randomized controlled feasibility trial where we plan to test the "exertion" online application. Therefore this project has potential to influence clinical practice for kidney transplant recipients. It will allow patients, who may not have routine access to physio or dietetic input to address weight gain with support. A study flow chart summarizing the project can be found below.
Detailed Description
This study is a qualitative study and intervention planning study to create and refine an online resource for weight management in new kidney transplant (KTx) recipients, which will be named "exertion". Objectives and hypothesis: The aim of this qualitative study is to use qualitative methods to create and refine a weight management, exercise/ physical activity online resource for patients with kidney transplant recipients. This study involves data collection via: Think-aloud interviews- 5 KTx patients and 2 Health Care Professionals (HCP) working in the transplant team will have recorded think aloud interviews using the resources. Other participants will be exposed to the resource during a routine lab session. Semi-structured interviews of transplant HCP's and KTx recipients. Demographic data including age, gender, occupation, smoking history, medical history, medication lists and baseline body weight (kg). Website/ resource log in data Field notes and observations from Think Aloud interviews, lab sessions and semi-structured interviews The investigators aim to recruit 10 new kidney transplant recipients and 5 transplant health care professionals to explore the following themes through 'Think-Aloud' interviews: The functionality of the "exertion" online resource for KTx recipients The functionality of the "exertion" online resource from a HCP perspective KTx participants interpretation of the "exertion" modules and resource as a whole HCP participants interpretation of the "exertion" modules and resource as a whole Thought processes involved to use the "exertion" application Recommendations from participants Likes/dislikes Barriers/ easier to use sections Highlight individual differences in the use of the "exertion" resource The investigators aim to explore the following themes through semi-structured individual interviews: What components of the online resource (exertion) are helpful/ unhelpful from a kidney transplant perspective? What components of the online resource are helpful/unhelpful from a kidney transplant HCP perspective? Are there any difficulties/ barriers participating in the study? And are they what were expected or different? Patients experiences and learning using the online application, and when the changes were noticed Anything missing/ they would recommend adding to the application Statistical Analysis: Baseline demographics of the participants will be described using summary statistics. Continuous variables will be summarized using the mean and standard deviation (SD) if approximately normally distributed. Continuous variables that are not normally distributed will be summarized using the median and IQR. Qualitative analysis: Data will be collected through in-depth feedback about the online intervention materials; field notes, individual interviews and 'Think-aloud' interviews. 'Think-aloud' interviews will be used to elicit participants' reactions to sessions of the online intervention; participants will be observed and asked to comment aloud on reactions to every aspect of the different sessions. Semi-structured interviews will explore participants' overall impressions of the online intervention. These qualitative techniques will allow for themes and sub-themes to emerge. The website will be designed to record user entries, and observational field notes about participants' use of the intervention will also be collected. Individual interviews will be transcribed verbatim and analysed using an inductive thematic analysis approach (17), informed by techniques of grounded theory (15), including line-by-line open coding grounded in data and constant comparison of all instances of codes. Deviant case codes will be employed to ensure that perspectives that diverge from dominant trends are not overlooked.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant; Complications, Obesity, Physical Activity, Weight Gain, Health Behavior
Keywords
Kidney transplant, Weight gain, Physical activity, Weight management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A small study creating a kidney transplant specific online weight gain prevention tool with qualitative data from 15 participants (5 transplant MDT members and 10 kidney transplant recipients)
Masking
None (Open Label)
Masking Description
No blinding. Purposive sampling of the 15 subjects- 5 HCP, 10 kidney transplant patients.
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Care Professionals
Arm Type
Other
Arm Description
A purposeful sample of 5 HCP's from the transplant team will test the online intervention and be interviewed using qualitative methods. This data will be analysed and used to plan a second study (feasibility RCT).
Arm Title
Kidney Transplant Patients
Arm Type
Other
Arm Description
A purposeful sample of 10 kidney transplant patients will test the online intervention and be interviewed using qualitative methods. This data will be analysed and used to plan a second study (feasibility RCT).
Intervention Type
Other
Intervention Name(s)
ExeRTiOn
Intervention Description
REHAB-online is an online weight gain prevention tool comprising of physical activity advice, dietetic advice, self-monitoring and tracking and behavioural change techniques. This resource is specific to kidney transplant patients and has been created by the research steering group including patient representation. During this study participants (both HCPs and patients) will have a one-off study visit to test and evaluate the online intervention.
Primary Outcome Measure Information:
Title
Patient experience and learning using the "ExeRTiOn" online resource
Description
Patient experience and learning using the "ExeRTiOn" online resource determined by qualitative interview
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Transplant health care professional experience and knowledge reviewing the online resource
Description
Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview
Time Frame
day 1
Title
Any difficulties/ barriers to participating in the study
Description
Any difficulties/ barriers to participating in the study determined by a qualitative interivew
Time Frame
day 1
Title
Any difficulties/ barriers to using the "ExeRTiOn" resource
Description
Any difficulties/ barriers to using the "ExeRTiOn" resource determined by a qualitative interview
Time Frame
day 1
Title
Components of the "ExeRTiOn" resource that are helpful/ unhelpful
Description
Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview
Time Frame
day 1
Title
Weakness of the "ExeRTiOn" resource
Description
Weakness of the "ExeRTiOn" resource determined by a qualitative interview
Time Frame
day 1
Title
Strengths of the "ExeRTiOn" resource
Description
Strengths of the "ExeRTiOn" resource determined by a qualitative interview
Time Frame
day 1
Title
feasibility and use of the ExeRTiOn resource
Description
log in time for the study visit and time using the resource will be recorded by the online resource
Time Frame
day 1
Title
feasibility outcome (adherence)
Description
adherence to study visits
Time Frame
day 1
Title
height
Description
measured in centimeters
Time Frame
day 1
Title
weight
Description
measured in kilograms
Time Frame
day 1
Title
Body mass index (BMI)
Description
weight and height will be combined to report BMI in kg/m2
Time Frame
day 1
Title
descriptive data
Description
descriptive data including gender, date of transplant and age
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility criteria for the Kidney Transplant Participants (n=10) Inclusion Criteria: adult patients (18years+) Male or female Written informed consent < 3 months post kidney transplant access to internet connected computer, smart-phone or tablet A Body Mass Index (BMI) greater than or equal to 18.5 (healthy range) Exclusion Criteria: pregnancy Unstable medical conditions such as; angina, uncontrolled hypertension or diabetes, congestive cardiac failure, active myocarditis/ pericarditis, cardiac arrhythmia, co-morbid catabolic conditions, psychiatric illness. Participated in a structured exercise or physical activity intervention in the last three months. BMI of less than 18.5 (classified as underweight) significant cognitive impairment preventing them from engaging with online interactive material Eligibility criteria for the Transplant Health Care Professionals (n=5) Inclusion criteria: A nephrologist, kidney doctor, nurse or member of the multi-disciplinary team who actively work with kidney transplant patients at King's College Hospital Adult above 18 years of age Able to provide written consent Access to Internet connected computer, smart-phone or tablet. Exclusion criteria: Pregnancy Unstable medical conditions such as angina, uncontrolled hypertension or diabetes, congestive cardiac failure, active myocarditis, cardiac arrhythmia, co-morbid catabolic condition, psychiatric illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Castle
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The research team plan to make de-identified participant data available as supplementary material to an online publication
IPD Sharing Time Frame
within 6-12 months of study completion
IPD Sharing Access Criteria
data will be available as supplementary material through online publication. For example Plos one.

Learn more about this trial

The wEight Management in Renal Transplant Online Study (ExeRTiOn)

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