Effectiveness of the CDK-SMS Nursing Intervention for Adults With Chronic Kidney Disease
Phase: PHASE4
Conditions: Renal Insufficiency, Chronic
Sponsor: Judith Medellin Olaya

 
 
 
 
 
 
Effectiveness of the CDK-SMS nursing intervention 
for adults with chronic kidney disease 
 
 
 
 
 
 
 
 
 
 
 
July 20, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 progress of this, 
and the prevention of complications derived from its development (1). 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"(2–4), most of which are modifiable, through 
self-management interventions. 
 
Self-management interventions aimed at adults with CKD in 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 health 
care costs by delaying the start of specialized treatments (renal replacement therapies) that 
require high technology and preventing complications that can lead to an 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 (5–9). 
 
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 (5,10). 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 (8,11–14), 
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 
(15–17). 
 
The nursing professional plays an important role in the execution of self-management 
interventions such as the CKD SMS, since it is who within the health team has the 
responsibility of imparting education and monitoring people, in the investigations found in 
most of the Regarding the interventions that have been carried out, the participation of the 
nursing professional has been fundamental since it is the one who is in constant interaction 
with the person. 
 
Research contributions to public policies 
Chronic kidney disease (CKD) represents a catastrophic public health problem that is 
growing worldwide, affecting 10% of the world's adult population (18). In Colombia, the 
high-cost account reported a prevalence of 3.5 cases per 1,000 inhabitants (19), ages 
ranging from 50 to 80 years. 90% of cases are in primary stages (stages 1,2,3 and 4), which 
do not require renal replacement therapies and in these stages, there is a window of 
opportunity to promote changes in lifestyles, adherence Therapeutic and self-management 
as intervention measures that can contribute to the prevention of disease progression, 
complications derived from it, and these variables have so far not been considered 
comprehensively in previous studies. 
 
In response to this problem, the World Health Organization calls attention to a 
comprehensive approach to chronic kidney disease, which should be aimed at improving 
the understanding, measurement, prevention and even treatment of it, also affirming that 
said approaches will contribute to the social appropriation of knowledge and the reduction 
of the burden of this disease in the future. The National Kidney Foundation (NKF), in its work 
to support the formulation of public policies, has reported the importance of health 
education and primary care, for the benefit of people's well-being and quality of life (20). 
 
At the national level, in addition to the clinical practice guide where care is framed and self-
management is mentioned as an approach tool, there are important regulations from the 
current health model, this has special strategies within which it must be addressed the care 
of people with CKD and makes explicit the importance of management from the early 
stages. Said strategies (19) are: primary health care that seeks to provide comprehensive 
care where disease prevention, diagnosis, treatment, and rehabilitation are found. 
 
Within primary care, there is a relevant strategy in the management of CKD, called health 
risk management, which is transversal within the comprehensive health care policy, this 
strategy is based on the articulation and interaction of the system agents in order to 
"identify, measure, intervene from prevention to palliation and carry out follow-up, 
monitoring and evaluation of risks to the health of people, families and communities, aimed 
at achieving results in health and well-being of the population "(2). 

 
Derived from this strategy, resolution 2565 of 2007 (21) was created, in which chronic 
kidney disease is defined as a high-cost disease, translated into mandatory notification of 
both the disease and also those precursor pathologies such as hypertension and diabetes ; 
Following the path of risk management, the high cost account in 2016 in its circular 0038 
(22), determines the adoption of the 4X4 strategy proposed by the WHO, which emphasizes 
the work for the implementation of interventions that are effective based on evidence to 
reduce risk factors and reduce the prevalence and mortality of non-communicable diseases, 
which for this case specifically is CKD. 
 
A tool that implements all the guidelines in the approach to the disease is the acquisition of 
self-management behaviors in people with CKD in early stages, which allows them to have 
a participation in the control of their health, making correct and informed decisions, but 
above all with the conviction in himself of being able to maintain his state of health, control 
and achieve objectives in relation to his disease, through the stimulation of self-efficacy. 
 
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. 
 
Specific objectives 
1. Describe the sociodemographic and clinical characteristics of the control group and the 
experimental group. 
2. Establish the level of self-efficacy, self-management behaviors and therapeutic 
adherence as a baseline in people with chronic kidney disease in early stages. 
3. To evaluate the changes in self-management behaviors, self-efficacy, and therapeutic 
adherence post-intervention and in the control group at 16 weeks. 
 
Hypothesis: 
- Establish that the CKD SMS intervention has a positive effect on self-efficacy and 
therapeutic adherence in people with early-stage CKD compared to usual care. 
- Establish the effectiveness of the CKD SMS intervention in improving self-management 
behaviors compared to the usual intervention in people with CKD in early stages. 
 
METHODOLOGY 

 
This is a quantitative investigation, with a pragmatic randomized clinical trial (pRCT) design, 
parallel experimental type, given the one-to-one allocation in two parallel groups with 
repeated pre-test and post-test measures, considering that this type of study it is useful for 
evaluating interventions in usual care (23). In CKD, the use of a pRCT enables a broader 
range of patients to be included to test an intervention applicable to patient care and to 
measure relevant patient-centered outcomes, thus improving external validity and 
translation of the results into the clinical care (24). 
 
Where the outcome variables are: Self-management behaviors (primary), self-efficacy and 
therapeutic adherence (secondary). The population will be adult men and women with 
chronic kidney disease in stages 1-4, who attend control of their disease or belong to the 
BBraun Avitum Prevenser program. 
 
Relevance of effectiveness measurement: 
Assuming that effectiveness refers to "the effects of an activity and its final results, benefits 
and consequences for a population in relation to the established objectives" (25), it is 
pertinent to measure this within the present study, since it is sought to really determine 
that the CKD SMS intervention improves the self-management behaviors of people with 
CKD in their real context, hence this measurement is the objective even of pragmatic clinical 
trials. And it differs from the efficacy that is more related to randomized clinical trials since 
they look for the “degree to which the intervention produces the hypothetical effects under 
ideal conditions” (26). 
 
POPULATION 
 
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. 
 
Accessible population: Adult population men and women with chronic kidney disease in 
stages 1-4, with different characteristics such as educational level, socioeconomic status, 
marital status, those who attend control of their disease or belong to the Prevenser 
program of the BBraun Avitum, in Colombia, which can be found in the databases provided 
by Prevenser program. 
 

Sampling frame: Database provided by Prevenser program population: It will be those 
participants who meet the inclusion and exclusion criteria, which are: 
 
Inclusion criteria 
- 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. 
 
Exclusion criteria 
- 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. 
 
SAMPLE 
 
Sample design: The sample size was calculated through probability sampling, since 
individuals have the same probability of being chosen. On the other hand, of the 
comparison of means in independent groups, assuming a power of 80%, a confidence level 
of 95%, an expected mean difference of 18.13 in the improvement of self-management, 
reported by previous studies (6,27). 
 
Sample size: A total of 82 participants (41 per group), in addition, a mortality of 20% of the 
participants is expected, so a total sample of 100 participants (50 per group) will be 
assumed. made in the Epidat 3.1 program. 
 
Randomization: Participants will be randomized into two groups, using sequentially 
numbered opaque sealed envelopes, where the investigator and participants will be blinded 
to the allocation of each group. For the generation of the randomization sequence, it will 
be developed by the investigator by means of the realization of a table of random numbers 
in the Epidat 3.1 program to eliminate the selection bias, in the same way, said table will be 
verified to guarantee balance between the number of participants assigned to each group 
(control and intervention). 
 
Blinding: In view of the need to minimize bias, both the participants and the recruitment 
research assistant will be blinded until allocation. The Result Research Assistant will not 
have access to the allocation base, nor to the allocation codes. On the other hand, it is 

declared that the intervention will be given by the researcher and that the main researcher 
will also participate in statistical analysis, therefore, the study is classified as single blind. 
 
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. 
 
PHASES OF THE STUDY 
 
The phases of the study will be pre-pilot phase in which the CKD SMS intervention will be 
adapted to the Colombian context, considering the evaluation by experts in the 
management of people with CKD in early stages. Pilot phase will be carried out the 
exploration of the field, followed by adjustments regarding the application time in the 
handling of the instruments and the training in these aspects for the research assistant. And 
the main phase of the study where the intervention will be implemented and the data will 
be collected, the latter by means of the instruments: characterization sheet, Self-
management instrument in early-stage chronic kidney disease CKD SM, EAT therapeutic 
adherence scale, Self-efficacy scale general. The intervention is planned to be implemented 
both in person and digitally assisted. 
 
INTERVENTIONS 
 
- CKD SMS intervention 
CKD SMS (Chronic Kidney Disease Self-Management Support) intervention (6,27), guided by 
the Social Cognitive Theory, through the manipulation of self-efficacy, is educational for the 
adult with CKD in early stages where a primer will be used which contains a primer that 
explains the functions of the kidneys, the first signs and symptoms of CKD and the strategies 
to control or delay the progression of CKD, such as the benefits of maintaining a healthy 
lifestyle and adherence to treatment. Also, a diary for participants to record side effects of 

medications, monitor their clinical data, treatment plan and questions for medical 
appointments. 
 
All the materials of the intervention will be prepared for an appropriate reading level for 
the participants and will be delivered in physical or digital format, the intervention will be 
provided by the researcher who is a nurse, a master's degree in nursing with an emphasis 
on chronic patient care and with experience of 12 years, of which 7 have been in the 
management of people with CKD in the different stages and in renal replacement therapies 
such as hemodialysis, peritoneal dialysis and kidney transplantation. 
 
The intervention begins with a face-to-face or digitally assisted session, entry into improving 
the knowledge and self-management of CKD through, using the four sources of 
manipulation of self-efficacy (achievement of performance, indirect experience, verbal 
persuasion, and self-evaluation). In this session, participants will be asked to identify their 
problems related to CKD and establish, based on these two goals, that they are real and 
achievable according to their priorities. These goals will be recorded in the monitoring 
format and will be monitored in the telephone or WhatsApp follow-ups. This using the 
performance achievement manipulation source, said session lasts 60 minutes, as does the 
final session at week 16 (6,27). 
 
For the use of vicarious or indirect experience, images will be used that demonstrate what 
should or should not be done within the educational material, in addition to the use of 
videos of successful experiences. Verbal persuasion will be used through providing verbal 
advice and suggestions to each participant. Self-assessment will be used to encourage 
participants to identify where they have been successful in the management of CKD and 
therapeutic adherence, in addition to expressing difficulties and concerns in managing their 
disease (6,27). 
 
The continuation of the intervention will be carried out through 2 follow-ups by phone or 
via WhatsApp with a duration of 20 to 30 minutes per week 4 and 12, where the research 
nurse will reinforce the self-management action plan and monitor progress towards the 
goals set; Therefore, the focus will be to identify improvements and encourage participants 
to continue with the change in behavior through positive reinforcement, in addition, 
discussion processes will be carried out according to the information given through the 
educational material given to the participant. The participant will be encouraged to seek 
family and social support to achieve long-term behavior changes, in addition to raising their 
concerns, doubts or concerns that arise during the intervention in each follow-up to be able 
to respond or, failing that, manage the resolution of these (6,27). 
 
The intervention is carried out individually, digitally assisted both for the meetings and for 
the follow-up, always trying to promote a quiet environment, free of noise and in the time 
agreed with the participant to give the intervention. 

 
- Conventional intervention 
The conventional intervention corresponds to the protocol established in the Prevenser 
program of the renal unit (BBraun Avitum) for the management of people with CKD in early 
stages. 
 
BIAS CONTROL 
 
Internal validity 
 
- Selection and performance bias: to avoid this bias, random selection will be carried out 
by delimiting the population and defining the sampling frame in detail, being adequate for 
the study design; in addition to the generation of a list of the patients who attend the 
controls, for the assignment of random numbers and the appropriate method for this by 
means of a software. On the other hand, allocation concealment will be carried out with 
sealed envelopes containing the allocation number; Within the calculation of the sample, 
an additional 20% is initially added as prevention of losses in the groups, additionally the 
intervention protocol will be carried out faithfully and the largest portion of the contact 
data of the participants will be taken in order not to lose the contact and their participation 
in the follow-up. 
- Performance and arrest bias: A single-blind study will be carried out in which the 
allocation to the participants will be blinded, since the intervention and the analysis of the 
results will probably have to be developed by the main investigator and therefore this 
cannot be blinded. But to have faithful results, the data collection (application of the 
instruments) will be supported by a research assistant who will also be blinded to the 
assignment of the participants to the control group or experimental group. 
- Attrition bias: The collection of the information will be meticulous in order not to lose any 
data, and, in addition, a percentage addition will be made in the calculation of the sample 
to predict the mortality of the participants. 
- Reporting bias: The delivery of the results without missing the expected results in 
accordance with the methodological approach, in the same way, will be its publication. 
 
External validity 
 
- Impossibility of replicating the treatments: the intervention is described in detail and aims 
to address a problem in clinical practice. 
- Effects of the experimenter: the research assistant in charge of collecting the data will be 
masked. 
- Reactive effects of the treatments: as mentioned in the intervention protocol, this will be 
developed initially in the context of the health institution and will continue in the normal 
context of the participant with prior agreement. 

- Interference from multiple treatments: within the exclusion criteria those who are 
participating in another research with an educational component different from the usual 
care are considered. 
 
Measurement instruments 
The information collection process will be carried out from the design of a form for the 
collection of sociodemographic data and clinical conditions of the participants and the 
application of the instruments for measuring both primary and secondary results: 
 
- Self-management instrument in early stages CKD SM chronic kidney disease: 30 items, 4 
factors (self-integration, problem solving, seeking social support and adherence to the 
recommended regimen), Cronbach's alpha of 0.95; English, Vietnamese, Taiwanese, and 
Mandarin languages. Likert scale evaluation, possible score from 29 to 116  (28). 
- Therapeutic adherence scale EAT: 21 items, 3 factors (control over the intake of drugs and 
food, medical-behavioral monitoring, and self-efficacy); Cronbach's alpha of 0.92, 
evaluation on a scale from 0 to 100; Spanish language (29). 
- General Self-efficacy Scale: 10 items, Cronbach's alpha of 0.87, in English and Spanish 
languages (30). 
 
APPROACH TO THE ANALYSIS FRAMEWORK 
 
To respond to specific objectives 1 and 2, a statistical analysis will be carried out through 
descriptive statistics. Subsequently, a normality test will be carried out, to identify how the 
data distribution is presented, in addition, it is carried out to determine the tests to be used, 
whether parametric or non-parametric in the inferential analysis, bivariate and multivariate 
analysis. A bivariate analysis, to compare the sociodemographic and clinical characteristics 
between the groups. 
 
To respond to specific objective 3, Inferential statistics will be carried out, which will be 
carried out to accept or reject the null or alternative hypothesis, which are proposed as: 
 
- H1: The CKD SMS intervention in self-management in people with CKD in early stages is 
effective on self-management behaviors, self-efficacy, and therapeutic adherence. (H1: G1> 
G2; p <0.05) 
- H0: The CKD SMS intervention in people with CKD in early stages is not effective on self-
management behaviors, self-efficacy, and therapeutic adherence. (H0: G1 = G2; p> 0.05) 
 
But it is also used multivariate analysis, to determine the individual relationship but also the 
relationship of the possible variables that intervene on the results, a simple logistic 
regression model will be built and adjusted according to the possible confounding variables. 
 
ETHICAL CONSIDERATIONS 

 
For this research, the ethical aspects of research in human beings are considered, for which 
national regulations and recommendations are considered, such as resolution 8430 of 
October 4, 1993 (31), issued by the Ministry of Health and establishes the scientific, 
technical, and administrative standards for health research. Taking into account these 
regulations, the research declares will be carried out with the authorization of the 
participant for which it will have informed consent, in addition to being carried out by a 
researcher with knowledge and experience in the subject and will have the approval of the 
ethics committee of the Faculty of Nursing of the National University of Colombia, will also 
have approval by the participating institution and authorization for the use of data 
collection instruments. 
 
On the other hand, the classification of the research is of risk greater than the minimum, 
since it includes the performance of an intervention; but it is proposed to improve the 
provision and the health status of the participants (31). This research contributes to the 
knowledge of an intervention that can be recommended and used in the future, which is 
included in the provision of services specifically in the care of people with chronic kidney 
disease in early stages and this type of research is already being considered that there is no 
other way to respond to the phenomenon studied. 
 
Informed consent will be in accordance with the criteria outlined in the resolution, which 
will explain the nature of the research, objectives, and in this process, emphasis will be 
placed on data confidentiality and voluntary participation. The prior signature and 
ratification of said knowledge will be the starting point for data collection, in this procedure 
sensitive data will not be included in order not to generate discrimination such as racial or 
ethnic origin, political orientation, religious or philosophical convictions, the data personnel 
to be recorded will be those strictly necessary and relevant for the completion of the 
investigation. 
 
In addition to the above, this research will guarantee and consider in all the guidelines for 
its development the ethical principles framed in the deontological code of Nursing (32), 
such as: 
 
- Respect: In this research, the use of informed consent by the participant will be 
guaranteed. In addition to other measures regarding the collection of data for which the 
participant will be identified with a code to safeguard their privacy and confidentiality, in 
this way their rights will be respected, and their dignity will be maintained, said number will 
be used in the instruments for collecting and analyzing information. 
 
- Beneficence and non-maleficence: For this research, an exhaustive critical review of the 
best available evidence was carried out, which made it possible to select the intervention 
proposed by Havas et al. (27) and later by Nguyent et al. (19), in people with disease chronic 

kidney disease in early stages. In addition, there are systematic reviews and meta-analyzes 
of experimental studies that have demonstrated the benefits of interventions in self-
management, on the other hand, if any risk condition is identified in the participant, the 
interdisciplinary treating group will be notified for its respective management. 
 
- Confidentiality and Privacy: It will be safeguarded through the management of the 
information where the data will be supervised, controlled, and processed by the researcher 
and the identity of the participants will be assigned a code for their identification. The 
information will not be transferred to people who are not part of the investigation team. 
 
- Veracity and Fidelity: It will be respected through the presentation of the research findings, 
where no type of manipulation will be carried out to obtain results. 
 
Additionally, the bioethical principle of reciprocity, meanwhile, the general findings of the 
research once completed, will be presented at the institution and participants. Likewise, 
the principle of justice, since the participants of the control group will receive feedback on 
their condition in the variables (self-efficacy, self-management behaviors and therapeutic 
adherence), in addition to specific recommendations to improve each of these and the 
delivery of educational material prepared in reciprocity for a transfer and social 
appropriation of knowledge to all participants. This study will comply with the provisions of 
the Declaration of Helsinki regarding the registration of experimental studies, as this 
according to the World Health Organization guarantees that the actors who participate in 
decision-making regarding health care have access A complete vision of the research, in 
addition, will constitute a resource that improves the transparency in the research, the 
validity and the value of the scientific databases, as well as it will also facilitate the 
identification of gaps in scientific research (33). 
 
Also, it will comply with Agreement 035 of 2003 of the National University of Colombia (34), 
in all matters concerning respect for intellectual property, through proper management of 
the institutional image, since if resources such as the institutional image are required for 
the generation of documents and pieces as in the case of educational material, the 
pertinent authorizations will be requested for this purpose. 
 
Environmental considerations: Regarding the environmental considerations that will be 
considered in this study, we have: The bibliographic references that will be used to give 
theoretical and conceptual support to the study during development will be obtained from 
systematized databases and that are within the resources of the University. On the other 
hand, environmental sustainability will be sought, using digital formats. 
 
Schedule 
 

 
 
EXPECTED RESULTS 
 
Among the expected results derived from the research, the presentation at an international 
scientific event and the production of a scientific article are planned. 
 
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