Renal InsufficiencyCKD-NLSMNCT03974646
Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM)
A study testing Nurse-led self-management Program in people with Renal Insufficiency, run by Universiti Putra Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Nurse-led self-management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants will be excluded if they had ESRD, were receiving dialysis or were cognitively impaired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM): A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Renal Insufficiency
- Being tested
- Nurse-led self-management Program
- Keywords
- chronic kidney disease, health related quality of life, knowledge, randomized controlled trial, self-management, self-efficacy, social cognitive theory
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led self-management ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Secondary outcomes (9)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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.
Measured: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jun 2020
- Primary completion31 Dec 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya
- Responsible party
- Principal investigator, Boon-How Chew, Universiti Putra Malaysia
- Investigators
- Boon How Chew, PhD, Study chair, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974646
- Sponsor's protocol ID
- AAlSawad
- Acronym
- CKD-NLSM
- Status last verified
- Nov 2022
- First submitted
- 29 May 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34143698
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM): A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03974646
- Acronym / sponsor ID
- CKD-NLSM / AAlSawad
- Conditions
- Renal Insufficiency
- Keywords
- chronic kidney disease, health related quality of life, knowledge, randomized controlled trial, self-management, self-efficacy, social cognitive theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- University of Malaya
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Nurse-led self-management ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants will be excluded if they had ESRD, were receiving dialysis or were cognitively impaired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led self-management ProgramGroup-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. | Behavioural | intervention group |
Primary outcome
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.
9 secondary outcomes
Change Self-efficacy to manage CKD.
Time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
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)
Change Systolic Blood Pressure
Time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Change 24-hour Urine Creatinine
Time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Change 24-hour Urine Protein
Time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Change 24-hour Urine Urea
Time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Change 24-hour Urine Sodium
Time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Change 24-hour Urine Potassium
Time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Change Diastolic Blood Pressure
Time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 34143698Ayat 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boon How Chew, PhD study chair
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led self-management Program in people with Renal Insufficiency, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change CKD knowledge (time frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.