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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03974646
Other study ID # AAlSawad
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date August 31, 2022

Study information

Verified date November 2022
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date August 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Nurse-led self-management Program
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.

Locations

Country Name City State
Malaysia Al Sawad, Ayat Serdang Selangor Darul Ehsan

Sponsors (2)

Lead Sponsor Collaborator
Universiti Putra Malaysia University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 Change Self-efficacy to manage CKD. Self-efficacy will be measured by using a self-report instrument the Stanford Self-Efficacy for Managing Chronic Disease - 6-item Scale. This widely used six-item instrument was derived from several self-efficacy scales developed and tested for the Chronic Disease Self-Management study by Lorig et al., 2001. Each item is scored on a 10-point Likert scale ranging from "not at all confident" (1) to "totally confident" (10), with a total score ranging from 6-60. The scale is scored by calculating the mean of at least four of the six items, therefore allowing for a maximum of two missing items. A higher number indicates a higher self-efficacy. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary Change Health-related quality of life (HRQoL): Malay KDQOL-36TM Health-related quality of life will be assessed using a self-report instrument Malay version of the Kidney Disease Quality of life (KDQOL-36TM) originally developed by RAND Health Organization, the University of Arizona for individuals with CKD and on dialysis. KDQOL-36TM consists of 12 items which measure physical functioning (physical component summary PCS) and mental functioning (mental component summary MCS), four items to assess the burden of kidney disease, 12 items for symptoms and problems, and eight items to measure the effects of kidney disease on daily life. The scores of the KDQOL-36TM are transformed into 0 to 100, with higher scores indicating better HRQoL. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary Change Systolic Blood Pressure Systolic Blood Pressure will be assessed using CARESCAPE DINAMAP technology digital blood pressure monitor model V100, BP assessor will obtain three BP measures in the right arm after the participant has been sitting quietly for 5 min. An average of the 3 measures is recorded. The recommended Systolic Blood Pressure lower of 130 mm Hg. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary Change 24-hour Urine Creatinine 24-hour urine creatinine will assessed using Jaffe, rate blanking for 24 hour urine collection with (mmol/24Hr) units of measures. The reference range for Males:3.45-21 mmol/24h and for Females: 7-14 mmol/24h. Higher than 21 mmol/24h and higher thank 14 mmol/24h is not recommended for male and female respectively. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary Change 24-hour Urine Protein 24-hour urine protein will assessed using Turbidimetric method Benzethonium chloride for 24 hour urine collection with (g/24Hr) units of measures. The reference range <0.14 g/24h. Higher than<0.14 g/24h is not recommended. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary Change 24-hour Urine Urea 24-hour Urine Urea will assessed using Kinetic test with urease and glutamate dehydrogenase for 24 hour urine collection with (mmol/24Hr) units of measures. The reference range is 428-714 mmol/24h. Higher than 714 mmol/24h is not recommended. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary Change 24-hour Urine Sodium 24-hour Urine Sodium will assessed using ISE indirect for 24 hour urine collection with (mmol/24Hr) units of measures.The reference range is 40-220 mmol/24hr. Higher than 220 mmol/24hr is not recommended. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary Change 24-hour Urine Potassium 24-hour Urine Potassium will assessed using ISE indirect for 24 hour urine collection with (mmol/24Hr) units of measures. The reference range 25-125 mmol/24hr. Higher than 125 mmol/24hr is not recommended. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary Change Diastolic Blood Pressure Diastolic Blood Pressure will be assessed using CARESCAPE DINAMAP technology digital blood pressure monitor model V100, BP assessor will obtain three BP measures in the right arm after the participant has been sitting quietly for 5 min. An average of the 3 measures is recorded.The recommended Diastolic Blood Pressure lower of 80 mm Hg. Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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