Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM)

University of Putra Malaysia (UPM)

Status: Completed

Conditions: Renal Insufficiency

Treatments: Behavioral: Nurse-led self-management Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03974646

AAlSawad

Details and patient eligibility

About

This study aims to develop, implement and evaluate the effectiveness of a theory-driven nurse-led self-management intervention program compared to standard usual care in people with CKD stages 3-4 on CKD knowledge, self-management behavior, self-efficacy and HRQoL using valid and reliable instruments in Malaysia.

Full description

Patients aged ≥ 18 years with CKD stages 3-4 will be recruited between July 2019 - October 2019. Participants will be randomly allocated into either the intervention (N = 77) or control group (N = 77). The control group will receive standard usual care, while the intervention group will receive standard usual care plus a self-management program delivered by renal nurse educators. The intervention will be guided by social cognitive theory and include group-based educational sessions, CKD booklet and follow-up phone calls. Both groups will be followed for 12 weeks. Data will be analyzed using SPSS version 25. The primary outcomes are improving in knowledge and self-management, while the secondary outcomes are improving in self-confidence, quality of life and clinical outcomes of the participants.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The inclusion criteria are CKD (stages 3-4), aged ≥ 18 years, could speak, read, and understand Malay language, able to give informed consent, had never participated in any structured education program before, willing to participate in the study and most importantly not expected to start dialysis during the study.

Exclusion criteria

• Participants will be excluded if they had ESRD, were receiving dialysis or were cognitively impaired.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

intervention group

Experimental group

Description:

Participants assigned to the intervention group will receive both will receive usual care (standard clinical and medical services) provided to individual with CKD stages 3-4 who attend the CKD clinic at medical outpatient department on their clinic follow up , and a 12- weeks self-management intervention delivered by two dedicated and trained renal nurse educators. The intervention will involve three group-based sessions, CKD booklet and three follow-up phone calls.

Treatment:

Behavioral: Nurse-led self-management Program

control group

No Intervention group

Description:

Participants randomized to the control group in this study will receive usual care (standard clinical and medical services) provided to individual with CKD stages 3-4 who attend the CKD clinic at medical outpatient department on their clinic follow up. Usual care consisted of brief verbal information (2-5 minutes) about taking medications, reducing salt, smoking cessation and reducing alcohol consumption. There will no structured program but only the provision of written material to patients.