The wEight Management in Renal Transplant Online Study (ExeRTiOn)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Kidney Transplant; Complications, Obesity, Physical Activity, Weight Gain, Health Behavior

Intervention / Treatment
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* Other: ExeRTiOn


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Health Care Professionals<br>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). | Other: ExeRTiOn<br>* 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.<br>|
| Other: Kidney Transplant Patients<br>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). | Other: ExeRTiOn<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient experience and learning using the ExeRTiOn online resource | Patient experience and learning using the ExeRTiOn online resource determined by qualitative interview | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | day 1 | 
| Any difficulties/ barriers to participating in the study | Any difficulties/ barriers to participating in the study determined by a qualitative interivew | day 1 | 
| Any difficulties/ barriers to using the ExeRTiOn resource | Any difficulties/ barriers to using the ExeRTiOn resource determined by a qualitative interview | day 1 | 
| Components of the ExeRTiOn resource that are helpful/ unhelpful | Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview | day 1 | 
| Weakness of the ExeRTiOn resource | Weakness of the ExeRTiOn resource determined by a qualitative interview | day 1 | 
| Strengths of the ExeRTiOn resource | Strengths of the ExeRTiOn resource determined by a qualitative interview | day 1 | 
| 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 | day 1 | 
| feasibility outcome (adherence) | adherence to study visits | day 1 | 
| height | measured in centimeters | day 1 | 
| weight | measured in kilograms | day 1 | 
| Body mass index (BMI) | weight and height will be combined to report BMI in kg/m2 | day 1 | 
| descriptive data | descriptive data including gender, date of transplant and age | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplant, Weight gain, Physical activity, Weight management