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

• ClinicalTrials.gov Identifier: NCT03699059
• Recruitment Status: Completed
• First Posted: October 9, 2018
• Last Update Posted: September 12, 2019
• Sponsor: King's College Hospital NHS Trust
• Collaborator: Kidney Research U.K.
• Information provided by (Responsible Party): King's College Hospital NHS Trust

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.

Condition or disease	Intervention/treatment	Phase
Kidney Transplant; Complications; Obesity; Physical Activity; Weight Gain; Health Behavior	Other: ExeRTiOn	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 31, 2018
• Actual Primary Completion Date: June 1, 2019
• Actual Study Completion Date: June 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Health Care Professionals; 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; 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.
Kidney Transplant Patients; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Patient experience and learning using the "ExeRTiOn" online resource [ Time Frame: day 1 ]
   Patient experience and learning using the "ExeRTiOn" online resource determined by qualitative interview

Secondary Outcome Measures :

1. Transplant health care professional experience and knowledge reviewing the online resource [ Time Frame: day 1 ]
   Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview
2. Any difficulties/ barriers to participating in the study [ Time Frame: day 1 ]
   Any difficulties/ barriers to participating in the study determined by a qualitative interivew
3. Any difficulties/ barriers to using the "ExeRTiOn" resource [ Time Frame: day 1 ]
   Any difficulties/ barriers to using the "ExeRTiOn" resource determined by a qualitative interview
4. Components of the "ExeRTiOn" resource that are helpful/ unhelpful [ Time Frame: day 1 ]
   Transplant health care professional experience and knowledge reviewing the online resource determined by qualitative interview
5. Weakness of the "ExeRTiOn" resource [ Time Frame: day 1 ]
   Weakness of the "ExeRTiOn" resource determined by a qualitative interview
6. Strengths of the "ExeRTiOn" resource [ Time Frame: day 1 ]
   Strengths of the "ExeRTiOn" resource determined by a qualitative interview
7. feasibility and use of the ExeRTiOn resource [ Time Frame: day 1 ]
   log in time for the study visit and time using the resource will be recorded by the online resource
8. feasibility outcome (adherence) [ Time Frame: day 1 ]
   adherence to study visits
9. height [ Time Frame: day 1 ]
   measured in centimeters
10. weight [ Time Frame: day 1 ]
    measured in kilograms
11. Body mass index (BMI) [ Time Frame: day 1 ]
    weight and height will be combined to report BMI in kg/m2
12. descriptive data [ Time Frame: day 1 ]
    descriptive data including gender, date of transplant and age

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United Kingdom

King's College Hospital

London, United Kingdom, SE5 9RS

Sponsors and Collaborators

King's College Hospital NHS Trust

Kidney Research U.K.

Investigators

• Principal Investigator: Ellen Castle; King's College Hospital NHS Trust

  Study Documents (Full-Text)

Documents provided by King's College Hospital NHS Trust:

Study Protocol and Statistical Analysis Plan  [PDF] March 6, 2018

More Information

• Responsible Party: King's College Hospital NHS Trust
• ClinicalTrials.gov Identifier: NCT03699059
• Other Study ID Numbers: KCH-EXERTION STUDY; 241928 ( Other Identifier: IRAS project ID ); KCH18-085 ( Other Identifier: Sponsor site reference number (King's College Hospital) )
• First Posted: October 9, 2018
• Last Update Posted: September 12, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The research team plan to make de-identified participant data available as supplementary material to an online publication
• Supporting Materials: Study Protocol; Clinical Study Report (CSR); Analytic Code
• Time Frame: within 6-12 months of study completion
• Access Criteria: data will be available as supplementary material through online publication. For example Plos one.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King's College Hospital NHS Trust:

Kidney transplant; Weight gain; Physical activity; Weight management

Additional relevant MeSH terms:

Body Weight; Weight Gain; Body Weight Changes