免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM) (CKD-NLSM)

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

Study Description
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.
Study Design
Layout table for study information
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.
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 31, 2021
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
Malaysia
Al Sawad, Ayat
Serdang, Selangor Darul Ehsan, Malaysia, 43400
Sponsors and Collaborators
Universiti Putra Malaysia
University of Malaya
Investigators
Layout table for investigator information
Study Chair: Boon How Chew, PhD Universiti Putra Malaysia
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Change CKD knowledge [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    Self-report instrument: Kidney Knowledge Survey (KiKS; Wright et al., 2011). This 28-item survey consists of multiple-choice questions investigating general CKD knowledge
  • Change CKD Self-Management Behavior [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    Self-report instrument: Chronic kidney disease self-management (CKD-SM) by (C. C. Lin et al., 2013).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Change Self-efficacy to manage CKD. [ Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention) ]
    Self-report instrument: the Stanford Self-Efficacy for Managing Chronic Disease - 6-item Scale (SEMCD-6; Lorig et al., 1996)
  • 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) ]
    Self-report instrument Malay 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.
  • Change Systolic and Diastolic 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM)
Official Title  ICMJE Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM): A Randomized Controlled Trial.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Renal Insufficiency
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Nurse-led self-management Program
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019) 		154
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974646
Other Study ID Numbers  ICMJE AAlSawad
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Boon-How Chew, Universiti Putra Malaysia
Study Sponsor  ICMJE Universiti Putra Malaysia
Collaborators  ICMJE University of Malaya
Investigators  ICMJE
Study Chair: Boon How Chew, PhD Universiti Putra Malaysia
PRS Account Universiti Putra Malaysia
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯