← Back to all trials
Recruiting
NCT05707260
Effectiveness of the CDK-SMS Nursing Intervention for Adults With Chronic Kidney Disease
Conditions: Renal Insufficiency, Chronic
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 120
Sponsor: Universidad Nacional de Colombia
Location: Colombia
Summary
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 VARIABLESAmong 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.INTERVENTIONSCKD SMS intervention CKD SMS (Chronic Kidney Disease Self-Management Support) interventionConventional 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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05707260). StuddyBuddy aggregates publicly available trial information.