Effectiveness of the CDK-SMS Intervention for Adults

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 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.

Conditions

• Renal Insufficiency, Chronic

Interventions

BEHAVIORAL

CKD SMS

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.

Sponsors & Collaborators

• Judith Medellin Olaya

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-20

Primary Completion

2023-11-28

Completion

2024-01-30

Countries

• Colombia