Kidney Transplant; ComplicationsExeRTiOnNCT03699059
The wEight Management in Renal Transplant Online Study (ExeRTiOn)
A study testing ExeRTiOn in people with Kidney Transplant; Complications and Obesity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant; Complications, Obesity, Physical Activity
- What is being tested?
- ExeRTiOn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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)
- Pregnancy
- Unstable medical conditions such as angina, uncontrolled hypertension or diabetes, congestive cardiac failure, active myocarditis, cardiac arrhythmia, co-morbid catabolic condition, psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Kidney Transplant; Complications, Obesity, Physical Activity, Weight Gain, Health Behavior
- Being tested
- ExeRTiOn
- Keywords
- Kidney transplant, Weight gain, Physical activity, Weight management
- Medical subject headings
- Obesity, Motor Activity, Weight Gain, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExeRTiOnOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Care Professionals | Other | 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). Receives: Other: ExeRTiOn |
| Kidney Transplant Patients | Other | 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). Receives: Other: ExeRTiOn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experience and learning using the "ExeRTiOn" online resource
Patient experience and learning using the "ExeRTiOn" online resource determined by qualitative interview
Measured: day 1
Secondary outcomes (12)
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
Measured: day 1
Any difficulties/ barriers to participating in the study
Any difficulties/ barriers to participating in the study determined by a qualitative interivew
Measured: day 1
Any difficulties/ barriers to using the "ExeRTiOn" resource
Any difficulties/ barriers to using the "ExeRTiOn" resource determined by a qualitative interview
Measured: 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
Measured: day 1
Weakness of the "ExeRTiOn" resource
Weakness of the "ExeRTiOn" resource determined by a qualitative interview
Measured: day 1
Strengths of the "ExeRTiOn" resource
Strengths of the "ExeRTiOn" resource determined by a qualitative interview
Measured: 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
Measured: day 1
feasibility outcome (adherence)
adherence to study visits
Measured: day 1
height
measured in centimeters
Measured: day 1
weight
measured in kilograms
Measured: day 1
Body mass index (BMI)
weight and height will be combined to report BMI in kg/m2
Measured: day 1
descriptive data
descriptive data including gender, date of transplant and age
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start31 May 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Kidney Research U.K.
- Responsible party
- Sponsor
- Investigators
- Ellen Castle, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699059
- Sponsor's protocol ID
- KCH-EXERTION STUDY
- Other IDs
- 241928, KCH18-085
- Acronym
- ExeRTiOn
- Status last verified
- Sep 2019
- First submitted
- 8 Aug 2018
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team plan to make de-identified participant data available as supplementary material to an online publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03699059
- Acronym / sponsor ID
- ExeRTiOn / KCH-EXERTION STUDY
- Conditions
- Kidney Transplant; Complications, Obesity, Physical Activity, Weight Gain, Health Behavior
- Keywords
- Kidney transplant, Weight gain, Physical activity, Weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Kidney Research U.K.
- Study start
- 31 May 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Health Care Professionals | Other | Other: ExeRTiOnA 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). |
| Kidney Transplant Patients | Other | Other: ExeRTiOnA 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- adult patients (18years+)
- Male or female
- Written informed consent
- < 3 months post kidney transplant
- access to internet connected computer, smart-phone or tablet
Key exclusion criteria (8 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExeRTiOnREHAB-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. | Other | Health Care Professionals, Kidney Transplant Patients |
Primary outcome
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
12 secondary outcomes
Transplant health care professional experience and knowledge reviewing the online resource
Time frame: day 1
Any difficulties/ barriers to participating in the study
Time frame: day 1
Any difficulties/ barriers to using the "ExeRTiOn" resource
Time frame: day 1
Components of the "ExeRTiOn" resource that are helpful/ unhelpful
Time frame: day 1
Weakness of the "ExeRTiOn" resource
Time frame: day 1
Strengths of the "ExeRTiOn" resource
Time frame: day 1
feasibility and use of the ExeRTiOn resource
Time frame: day 1
feasibility outcome (adherence)
Time frame: day 1
height
Time frame: day 1
weight
Time frame: day 1
Body mass index (BMI)
Time frame: day 1
descriptive data
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: Yes. The research team plan to make de-identified participant data available as supplementary material to an online publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Castle principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExeRTiOn in people with Kidney Transplant; Complications and Obesity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient experience and learning using the "ExeRTiOn" online resource (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.