跳至主要内容
临床试验/NCT05707260
NCT05707260已完成4 期

Effectiveness of the CDK-SMS Nursing Intervention for Adults With Chronic Kidney Disease

Judith Medellin Olaya1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年7月20日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
self management

研究概览

简要总结

Type of Study: a pragmatic randomized clinical trial. Research question How effective is the CKD SMS self-management nursing intervention on self-management behaviors, self-efficacy, and adherence in adults with early-stage CKD compared to usual care? General objective To determine the effectiveness of the self-management nursing intervention (CKD SMS) on self-management behaviors, self-efficacy, and therapeutic adherence in people with CKD in early stages compared to usual care.

Target population: Adult men and women with chronic kidney disease in stages 1-4, with different characteristics such as educational level, socioeconomic status, and marital status. Taking into account that the definition of early stages through the criteria demarcated by the Colombian clinical practice guideline, where the glomerular filtration rate (GFR) is the indicator for stratification as follows: stage 1 people with a GFR less than or equal to 90 (ml (min / 1.73 m2), stage 2 people with GFR between 60-89 (ml (min / 1.73 m2), stage 3 people with GFR between 30-59 (ml (min / 1.73 m2)) and stage 4 people with GFR between 15-30 (ml (min / 1.73 m2) who attend kidney protection programs of the Renal Units in Colombia.

STUDY VARIABLES

Among the variables that are available for the present study are:

  • Independent Variables: Sociodemographic characteristics, related to the disease or clinical condition and the CKD intervention.
  • Dependent variables: Self-management behaviors, therapeutic adherence, and self-efficacy.

Within the mediating, shaping or confounding variables, the following are found according to what is established in the literature: age, gender, level of education, time of diagnosis and other comorbidities, which are initially considered independent variables and will be measured. In the study, for its management, strategies such as randomization will be used, the differences between the crude estimates of an association and those adjusted considering a confounding variable will be identified and its adjustment is responsible for at least 10% in the magnitude of the difference.

INTERVENTIONS

  • CKD SMS intervention CKD SMS (Chronic Kidney Disease Self-Management Support) intervention
  • Conventional intervention The conventional intervention corresponds to the protocol established in the program of the renal unit for the management of people with CKD in early stages.

详细描述

Scope and justification of the proposal

Chronic kidney disease is a complex pathology, where the person who suffers from it is faced with unexpected changes in their customs and lifestyles, in addition to complying with a strict therapeutic regimen, because from its diagnosis it seeks to delay the progress of this, and the prevention of complications derived from its development. Within the disease management guidelines at the European level, which were necessary for the Colombian context, they recommend that the factors associated with disease progression should be addressed, which include: "the cause of the disease, the level of the glomerular filtration rate, the level of albuminuria, age, sex, race/ethnicity, elevated blood pressure, hyperglycemia, dyslipidemia, smoking, obesity, history of cardiovascular disease, continued exposure to nephrotoxic agents and others", most of which are modifiable, through self-management interventions.

Self-management interventions aimed at adults with CKD in its early stages contribute to improving the quality of life, self-management behaviors, and self-efficacy, but above all in the prevention of complications derived from the disease. Preventing a person with CKD from progressing to advanced stages or terminal management phases leads to lower healthcare costs by delaying the start of specialized treatments (renal replacement therapies) that require high technology and preventing complications that can lead to increased mortality in the population. Results that have been considered within health policies and therefore have become a premise that justifies the relevance of the nursing intervention in self-management.

The nursing intervention in self-management implies advancing in approaches where adults with early-stage CKD are active agents in managing their own care towards awareness and responsibility for the daily care of the disease. Today there is a nursing intervention in self-management the CKD SMS, designed specifically for the population object of this study, which has been administered in two countries where there are different socio-economic and cultural characteristics (Vietnam and Australia), demonstrating feasibility in its implementation and acceptability by the participants, in addition to being effective in promoting self-management behaviors, a comprehensive and novel construct, which is achieved through the manipulation of self-efficacy.

In the present proposal, therapeutic adherence is a central concept since it is expected that when performing the nursing intervention in self-management, adherence to the therapeutic regimen will increase, evidenced in the exercise of healthy habits, such as the intake of a diet in accordance with its condition and the reduction of risk factors inherent to the disease, also translated into the impact of these factors on clinical control variables such as: improving blood pressure control, glycosylated hemoglobin levels, but also an important impact in delaying the progression of the disease, which is evidenced not only by not requiring renal replacement therapies, but also by maintaining or improving the glomerular filtration rate, which is beneficial for both the person and for the health system.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults, of legal age for Colombia (18 years), with a diagnosis of chronic kidney disease in stages 1-4, without renal replacement therapy according to the Kdigo guidelines.
  • People without comorbidity and with non-decompensated or exacerbated chronic comorbidities.
  • People in use of their mental and communication faculties.

排除标准

  • People who are under the effect of some substance that alters the mental state.
  • People under 18 years of age.
  • Being receiving renal replacement therapy or being in a terminal stage.
  • Illiterate people.
  • People who are participating in another educational intervention different from the usual care.

结局指标

主要结局

self management

时间窗: 4 month

Self-management behaviors will be measured using the chronic kidney disease self-management instrument (CKD-SM), whose validity and reliability will be evaluated in the pre-pilot phase. The CKD-SM self-report instrument consists of 32 items and measures whether participants perform a variety of self-management behavior factors, including: self-integration (11 items); problem solving (11 items); search for social support (5 items); and adherence to the recommended regimen (5 items). The subscales are evaluated by adding the scores for each item using a Likert scale from 1 to 4; 1 = never, 2 = sometimes, 3 = usually, 4 = always. Total CKD-SM scores are also measured by summing the scores on the four subscales and can range from 32 to 128. High scores indicate a high level of CKD self-management behaviors

次要结局

  • Self-efficacy(4 month)
  • Therapeutic adherence(4 month)

研究者

发起方
Judith Medellin Olaya
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Judith Medellin Olaya

Principal Investigator

Universidad Nacional de Colombia

研究点 (1)

Loading locations...

相似试验