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

NCT03974646 | Completed DMC

• 1 other identifier: AAlSawad
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency

Keywords

chronic kidney disease; health related quality of life; knowledge; randomized controlled trial; self-management; self-efficacy; social cognitive theory

Outcome Measures

Primary Outcomes (2)

• Change CKD knowledge

  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.

  Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)

• Change CKD Self-Management Behavior

  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.

  Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)

Secondary Outcomes (9)

• Change Self-efficacy to manage CKD.

  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 Systolic Blood Pressure

  Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)

• Change 24-hour Urine Creatinine

  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)

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Behavioral: Nurse-led self-management Program

control group

NO INTERVENTION

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.

Interventions

Nurse-led self-management Program BEHAVIORAL

Group-based sessions will be scheduled at week two, week four and week six. Participant will be given a printed booklet Participants will receive three individual follow-up phone calls of 20-30 minutes each at week three, week five and week seven.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• University of Malaya: collaborator

Study Sites (1)

Al Sawad, Ayat

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 34143698 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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 Officials

• Boon How Chew, PhD

  Universiti Putra Malaysia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 5, 2019
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

MY (1)