Effectiveness of the CDK-SMS Intervention for Adults

NCT05707260 | Completed Phase 4

• 1 other identifier: 026-21
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• self management

  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

  4 month

Secondary Outcomes (2)

• Self-efficacy

  4 month

• Therapeutic adherence

  4 month

Study Arms (2)

CKD SMS intervention

ACTIVE COMPARATOR

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.

Behavioral: CKD SMS

Conventional intervention

NO 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.

Interventions

CKD SMS BEHAVIORAL

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.

CKD SMS intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Judith Medellin Olaya: lead

Study Sites (1)

Judith Medellin Olaya

Bogotá, Cundinamarca, Colombia

Location

Related Publications (21)

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• Lewis RA, Lunney M, Chong C, Tonelli M. Identifying Mobile Applications Aimed at Self-Management in People With Chronic Kidney Disease. Can J Kidney Health Dis. 2019 Mar 13;6:2054358119834283. doi: 10.1177/2054358119834283. eCollection 2019.

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• Zimbudzi E, Lo C, Misso M, Ranasinha S, Zoungas S. Effectiveness of management models for facilitating self-management and patient outcomes in adults with diabetes and chronic kidney disease. Syst Rev. 2015 Jun 10;4:81. doi: 10.1186/s13643-015-0072-9.

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• Bonner A, Havas K, Douglas C, Thepha T, Bennett P, Clark R. Self-management programmes in stages 1-4 chronic kidney disease: a literature review. J Ren Care. 2014 Sep;40(3):194-204. doi: 10.1111/jorc.12058. Epub 2014 Mar 14.

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• Lee MC, Wu SV, Hsieh NC, Tsai JM. Self-Management Programs on eGFR, Depression, and Quality of Life among Patients with Chronic Kidney Disease: A Meta-Analysis. Asian Nurs Res (Korean Soc Nurs Sci). 2016 Dec;10(4):255-262. doi: 10.1016/j.anr.2016.04.002. Epub 2016 May 13.

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• Havas K, Douglas C, Bonner A. Person-centred care in chronic kidney disease: a cross-sectional study of patients' desires for self-management support. BMC Nephrol. 2017 Jan 13;18(1):17. doi: 10.1186/s12882-016-0416-2.

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• Gorostidi M, Santamaria R, Alcazar R, Fernandez-Fresnedo G, Galceran JM, Goicoechea M, Oliveras A, Portoles J, Rubio E, Segura J, Aranda P, de Francisco AL, Del Pino MD, Fernandez-Vega F, Gorriz JL, Luno J, Marin R, Martinez I, Martinez-Castelao A, Orte LM, Quereda C, Rodriguez-Perez JC, Rodriguez M, Ruilope LM. Spanish Society of Nephrology document on KDIGO guidelines for the assessment and treatment of chronic kidney disease. Nefrologia. 2014 May 21;34(3):302-16. doi: 10.3265/Nefrologia.pre2014.Feb.12464. Epub 2014 Mar 6. English, Spanish.

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• Lopez-Vargas PA, Tong A, Howell M, Craig JC. Educational Interventions for Patients With CKD: A Systematic Review. Am J Kidney Dis. 2016 Sep;68(3):353-70. doi: 10.1053/j.ajkd.2016.01.022. Epub 2016 Mar 26.

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• Havas K, Bonner A, Douglas C. Self-management support for people with chronic kidney disease: Patient perspectives. J Ren Care. 2016 Mar;42(1):7-14. doi: 10.1111/jorc.12140. Epub 2015 Sep 24.

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• Donald M, Kahlon BK, Beanlands H, Straus S, Ronksley P, Herrington G, Tong A, Grill A, Waldvogel B, Large CA, Large CL, Harwood L, Novak M, James MT, Elliott M, Fernandez N, Brimble S, Samuel S, Hemmelgarn BR. Self-management interventions for adults with chronic kidney disease: a scoping review. BMJ Open. 2018 Mar 22;8(3):e019814. doi: 10.1136/bmjopen-2017-019814.

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• Peñarrieta MI, Flores-Barrios F, Gutiérrez-Gómez T, Piñones -Martínez S, Resendiz -Gonzalez E, María Quintero-Valle L. Self-management and family support in chronic diseases. J Nurs Educ Pract [Internet]. 2015 [cited 2019 Oct 1];5(11). Available from: www.sciedu.ca/jnepURL:http://dx.doi.org/10.5430/jnep.vXnXpXX

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• Lin MY, Liu MF, Hsu LF, Tsai PS. Effects of self-management on chronic kidney disease: A meta-analysis. Int J Nurs Stud. 2017 Sep;74:128-137. doi: 10.1016/j.ijnurstu.2017.06.008. Epub 2017 Jun 21.

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• Zimbudzi E, Lo C, Misso ML, Ranasinha S, Kerr PG, Teede HJ, Zoungas S. Effectiveness of self-management support interventions for people with comorbid diabetes and chronic kidney disease: a systematic review and meta-analysis. Syst Rev. 2018 Jun 13;7(1):84. doi: 10.1186/s13643-018-0748-z.

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• Havas K, Douglas C, Bonner A. Meeting patients where they are: improving outcomes in early chronic kidney disease with tailored self-management support (the CKD-SMS study). BMC Nephrol. 2018 Oct 20;19(1):279. doi: 10.1186/s12882-018-1075-2.

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• Lin CC, Tsai FM, Lin HS, Hwang SJ, Chen HC. Effects of a self-management program on patients with early-stage chronic kidney disease: a pilot study. Appl Nurs Res. 2013 Aug;26(3):151-6. doi: 10.1016/j.apnr.2013.01.002. Epub 2013 Mar 7.

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• Peng S, He J, Huang J, Lun L, Zeng J, Zeng S, Zhang L, Liu X, Wu Y. Self-management interventions for chronic kidney disease: a systematic review and meta-analysis. BMC Nephrol. 2019 Apr 26;20(1):142. doi: 10.1186/s12882-019-1309-y.

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• Sorait W. The association of self-efficacy and self-management behavior in adult patients with chronic kidney disease: an integrative review. J Kidney Treat Diagnosis [Internet]. 2018 Jun 17 [cited 2020 Jul 4];1(1). Available from: https://www.pulsus.com/scholarly-articles/the-association-of-selfefficacy-and-selfmanagement-behavior-in-adult-patients-with-chronic-kidney-disease-an-integrative-review-4587.html

  BACKGROUND

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MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 31, 2023
• Study Start: July 20, 2022
• Primary Completion: November 28, 2023
• Study Completion: January 30, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting in January 2025
• Access Criteria: The information shared will be made through the database built with the information collected from the study where only the patients are identified by assigned codes to ensure their privacy, this information will only be shared with the study researchers, and will be shared in publications only information resulting from statistical analysis.

Locations

CO (1)