Effectiveness of the CDK-SMS Intervention for Adults

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional · Phase 4
• Participants enrolled: 120
• From 20 Jul 2022 to the primary completion date, 28 Nov 2023
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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