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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Patient experience and learning using the "ExeRTiOn" online resource
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No blinding. Purposive sampling of the 15 subjects- 5 HCP, 10 kidney transplant patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Patient experience and learning using the "ExeRTiOn" online resource
时间窗: day 1
Patient experience and learning using the "ExeRTiOn" online resource determined by qualitative interview
次要结局
- Transplant health care professional experience and knowledge reviewing the online resource(day 1)
- Weakness of the "ExeRTiOn" resource(day 1)
- Any difficulties/ barriers to using the "ExeRTiOn" resource(day 1)
- Strengths of the "ExeRTiOn" resource(day 1)
- Body mass index (BMI)(day 1)
- Any difficulties/ barriers to participating in the study(day 1)
- Components of the "ExeRTiOn" resource that are helpful/ unhelpful(day 1)
- weight(day 1)
- feasibility and use of the ExeRTiOn resource(day 1)
- feasibility outcome (adherence)(day 1)
- height(day 1)
- descriptive data(day 1)