Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM): A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Change CKD knowledge
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
intervention group
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.
Intervention: Nurse-led self-management Program (Behavioral)
control group
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.
Outcomes
Primary Outcomes
Change CKD knowledge
Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
kidney disease knowledge will be measured using a self-report instrument Kidney Disease Knowledge Survey (KiKS). It includes 28 questions, 5 multiple choice type questions and 23 Yes-No questions; none of the questions included an "I don´t know" option. To assess the survey score, 1 point was given to each correct answer and zero to each wrong one. The questionnaire doesn't have domains, and the total score was calculated as the sum of the correct responses to each question divided by the total number of questions, which results in values from 0 to 1 where 1 means the highest level of knowledge.
Change CKD Self-Management Behavior
Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
CKD self-management behavior will be assessed by Self-report instrument Chronic Kidney Disease Self-management (CKD-SM) by (C. C. Lin et al., 2013). CKD-SM instrument contains of 29-item to measure participants' self-management behavior factors. Each item is scored on a Likert scale from 1-4 with 1 being 'never' and 4 'always'. Total scores of the CKD-SM range from 29 to 116 and higher scores indicate better self-management behavior in managing CKD.
Secondary Outcomes
- Change 24-hour Urine Creatinine(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change Systolic Blood Pressure(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change Diastolic Blood Pressure(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change 24-hour Urine Sodium(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change Self-efficacy to manage CKD.(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change 24-hour Urine Protein(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change Health-related quality of life (HRQoL): Malay KDQOL-36TM(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change 24-hour Urine Urea(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change 24-hour Urine Potassium(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
Investigators
Boon-How Chew
Associate Professor
Universiti Putra Malaysia