Testing the Effect of a New Health Communication Intervention for Renal Transplant Recipients (KnowMAP).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Health literacy (HL)
研究概览
简要总结
A randomized controlled study (RCT) aiming to test the effect of a new health literacy intervention for renal transplant recipients, KnowMAP (knowledge management for renal transplant recipients).
详细描述
Every year about 250-300 kidney transplantations are performed at Oslo University Hospital in Norway. Considerable improvements have recently emerged within kidney transplantation in relation to survival and quality of life. However, after transplantation, adherence to immunosuppressive drug therapy and other medical advices is crucial for staying healthy, keeping the graft, and retain good quality of life. In case of graft loss the patient has to return to dialysis, representing reduced functioning, fatigue and negative impact on quality of life. Dialysis also leads to higher costs for the society and in many cases a need for re-transplantation. A key challenge to adherence is the ability to gain access to, understand and use health information, defined as health literacy by the WHO. For renal transplant recipients preparedness for handling information and going through transplantation is essential. Hence, supporting the patients becoming reflective and health literate knowledge users is crucial.
Through a RCT this project aims to test the effect of a new health communication intervention, KnowMAP (knowledge management for renal transplant recipients), as compared with standard care in patients undergoing renal transplantation.
KnowMap is a novel intervention designed by clinicians and researchers at Oslo University Hospital (OUS), University of Oslo (UiO) and University of Stavanger (UiS). The intervention is targeting knowledge management skills of patients by using motivational interview (MI) techniques. It represents 4 sessions of individual patient counselling starting the first week after the transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Block randomization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplanted patients > 18 years included within few days after kidney transplantation at Oslo University Hospital
- •Able to speak and understand Norwegian
排除标准
- •Not able to speak or understand Norwegian well enough to be able to fill out forms or have a conversation in Norwegian.
- •Kidney transplanted patient <18 years
结局指标
主要结局
Health literacy (HL)
时间窗: 24 months post transplantation
HL measured by the HLQ (Health Literacy Questionnaire): The HLQ includes 44 items over nine independent scales, each representing a different element of the overall HL construct. Each scale includes 4-6 items. The first five scales comprise items asking the respondents to indicate level of agreement \[ranging from strongly disagree to strongly agree (range 1-4)\]. The remaining scales (6-9) have domains of self-reported capability (range 1-5: 'cannot do' to 'very easy'). The questionnaire has no total score, as that could potentially mask individual needs in specific HL domains. The HLQ appears robust for its intended purpose of assessing HL in a range of settings and has shown excellent reliability.
Adherence to immunosuppressive medication
时间窗: 24 months post transplantation
The instrument BAASIS (The BAsel Adherence to immunoSuppressIve medication Scale) a self reporting adherence questionnaire measuring patients' taking, skipping, timing (\>2 hrs from prescribed time) and dose reduction of drugs. The recall period is limited to four weeks. The BAASIS comprises four questions with a 6-point scale for responses ranging from never (0) to every day (5)
次要结局
- Knowledge(24 months post transplantation)
- Occations of graft loss(24 months post transplantation)
- Quality of life and cost-effectiveness estimates relevant to this clinical context(24 months post transplantation)
研究者
Tone Vidnes
PhD student
Oslo University Hospital