Clinical trial NCT03974646: Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM)
Official title: Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM): A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency
Keywords: chronic kidney disease
health related quality of life
knowledge
randomized controlled trial
self-management
self-efficacy
social cognitive theory
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: University of Malaya
First posted: 2019-06-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients fulfilling eligibility criteria and willing to participate will randomized after baseline assessment (1:1 allocation ration). A prior, an independent research assistant will prepare a computer-generated randomization schedule. The allocation numbers will be concealed in opaque sealed envelopes prepared by a research assistant. the envelopes will be accessible by the research assistant, only opening them after informed consent and baseline assessment have been obtained.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change CKD knowledge
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change CKD Self-Management Behavior
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary outcomes:
measure: Change Self-efficacy to manage CKD.
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change Health-related quality of life (HRQoL): Malay KDQOL-36TM
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change Systolic Blood Pressure
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change 24-hour Urine Creatinine
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change 24-hour Urine Protein
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change 24-hour Urine Urea
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change 24-hour Urine Sodium
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change 24-hour Urine Potassium
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
measure: Change Diastolic Blood Pressure
timeFrame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Al Sawad, Ayat
state: Selangor Darul Ehsan
Study officials:
affiliation: Universiti Putra Malaysia
name: Boon How Chew, PhD
role: STUDY_CHAIR
References:
citation: Ayat Ali AS, Lim SK, Tang LY, Rashid AA, Chew BH. The effectiveness of nurse-led self-management support program for people with chronic kidney disease stage 3-4 (CKD-NLSM): Study protocol for a randomized controlled trial. Sci Prog. 2021 Apr-Jun;104(2):368504211026159. doi: 10.1177/00368504211026159.