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| ID | Type | Description | Link |
|---|---|---|---|
| 241928 | Other Identifier | IRAS project ID | |
| KCH18-085 | Other Identifier | Sponsor site reference number (King's College Hospital) |
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| Name | Class |
|---|---|
| Kidney Research U.K. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExeRTiOn | Other | 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. |
| 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 |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Castle | King's College Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital | London | SE5 9RS | United Kingdom |
The research team plan to make de-identified participant data available as supplementary material to an online publication
within 6-12 months of study completion
data will be available as supplementary material through online publication. For example Plos one.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2018 | Jul 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D015430 | Weight Gain |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005082 | Physical Exertion |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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)
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No blinding. Purposive sampling of the 15 subjects- 5 HCP, 10 kidney transplant patients.
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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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |