King's College Hospital
London, SE5 9RS, United Kingdom
NCT Number: NCT03699059
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
London, SE5 9RS, United Kingdom
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:
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 investigators aim to explore the following themes through semi-structured individual interviews:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Eligibility criteria for the Kidney Transplant Participants (n=10)
Inclusion criteria
Exclusion criteria
Eligibility criteria for the Transplant Health Care Professionals (n=5)
Inclusion criteria
Exclusion criteria
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.
Time frame: day 1
Patient experience and learning using the "ExeRTiOn" online resource determined by qualitative interview
Time frame: day 1
Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview
Time frame: day 1
Any difficulties/ barriers to participating in the study determined by a qualitative interivew
Time frame: day 1
Any difficulties/ barriers to using the "ExeRTiOn" resource determined by a qualitative interview
Time frame: day 1
Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview
Time frame: day 1
Weakness of the "ExeRTiOn" resource determined by a qualitative interview
Time frame: day 1
Strengths of the "ExeRTiOn" resource determined by a qualitative interview
Time frame: day 1
log in time for the study visit and time using the resource will be recorded by the online resource
Time frame: day 1
adherence to study visits
Time frame: day 1
measured in centimeters
Time frame: day 1
measured in kilograms
Time frame: day 1
weight and height will be combined to report BMI in kg/m2
Time frame: day 1
descriptive data including gender, date of transplant and age
King's College Hospital NHS Trust
Other
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)
Acronym: ExeRTiOn
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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