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

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ClinicalTrials.gov Identifier: NCT03974646
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Boon-How Chew, Universiti Putra Malaysia

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Behavioral: Nurse-led self-management Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM): A Randomized Controlled Trial.
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : December 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: 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.



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Change Self-efficacy to manage CKD. [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.

  2. Change Health-related quality of life (HRQoL): Malay KDQOL-36TM [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.

  3. Change Systolic Blood Pressure [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.

  4. Change 24-hour Urine Creatinine [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.

  5. Change 24-hour Urine Protein [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.

  6. Change 24-hour Urine Urea [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.

  7. Change 24-hour Urine Sodium [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.

  8. Change 24-hour Urine Potassium [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.

  9. Change Diastolic Blood Pressure [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974646


Contacts
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Contact: Ayat Ali Al Sawad, MSc 61123137114 ayat.alsawad@gmail.com

Locations
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Malaysia
Al Sawad, Ayat Not yet recruiting
Serdang, Selangor Darul Ehsan, Malaysia, 43400
Contact: Al S Ayat    +61123137114 ext +61123137114    Ayat.alsawad@gmail.com   
Contact: Boon How Chew    +60126900652    chewboonhow@upm.edu.my   
Sponsors and Collaborators
Universiti Putra Malaysia
University of Malaya
Investigators
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Study Chair: Boon How Chew, PhD Universiti Putra Malaysia

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Responsible Party: Boon-How Chew, Associate Professor, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT03974646     History of Changes
Other Study ID Numbers: AAlSawad
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boon-How Chew, Universiti Putra Malaysia:
chronic kidney disease
health related quality of life
knowledge
randomized controlled trial
self-management
self-efficacy
social cognitive theory

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases