Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000038493
Ethics application status
Approved
Date submitted
11/01/2016
Date registered
19/01/2016
Date last updated
4/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A nurse-led self-management program for people with chronic kidney disease (stages 3-5).
Scientific title
A pragmatic randomised controlled trial to assess knowledge and self-management behaviours in people with chronic kidney disease (stages 3-5) who receive a nurse-led intervention in Vietnam.
Secondary ID [1] 288233 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 297158 0
Condition category
Condition code
Renal and Urogenital 297377 297377 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Social cognitive theory has informed the intervention which consists of a one-hour individual face-to-face session (60 minutes duration), a booklet of ‘Looking After My Kidneys and Health’ (adapted and translated in Vietnamese with permission from Kidney Health Australia and American Kidney Foundation), and two follow up phone calls at week 4 and week 12 (20 to 30 minutes duration). Both the face-to-face session (outpatient clinic) and follow-up phone calls are provided by the nurse (principal researcher). The face-to-face session covers information about chronic kidney disease, medications, lifestyle modifications, and self-management skills based on the content of the booklet. It is also used to set individual self-management goals. Participants will also be asked to use the ‘Looking After My Kidneys and Health’ booklet at home to guide their self-management goals. Information is reinforced during the follow-up phone calls. Adherence to the protocol is monitored by a log of successful phone call follow up sessions and return to the clinic for routine renal care.
Intervention code [1] 293534 0
Treatment: Other
Comparator / control treatment
Standard renal care at the clinic will be given to all of the participants with chronic kidney disease in this study. There is no structured education about chronic kidney disease and neither any written information provided. Medical and nursing staff deliver very brief verbal instructions on taking medications and basic healthcare advice about returning to the outpatient clinic to be reviewed by a medical practitioner.
At the end of the study participants in the control group will receive the CKD booklet from the Principal researcher.
Control group
Active

Outcomes
Primary outcome [1] 296951 0
The first primary outcome is chronic kidney disease self-management which is measured by the Vietnamese version of the CKD self-management instrument. The instrument has been validated in the study population.
Timepoint [1] 296951 0
The outcome will be measured at time point 1: baseline
Repeated measurement: - Time point 2: week 8, Time point 3: week 16
Primary outcome [2] 296953 0
The second primary outcome is chronic kidney disease knowledge assessed using the Vietnamese version of the kidney knowledge survey (KiKS). This instrument measures knowledge related to kidney disease management, such as kidney functions, treatment options for kidney failure, signs and symptoms of disease progression, potential medications that harm or benefit the kidney, blood pressure targets, and other information related to preserving kidney function. The instrument has been validated in the study population.
Timepoint [2] 296953 0
The outcome will be measured at time point 1: baseline
Repeated measurement: - Time point 2: week 8, Time point 3: week 16
Secondary outcome [1] 319753 0
Blood pressure obtained from patient's medical records.
Timepoint [1] 319753 0
The outcome will be measured at time point 1: baseline
Repeated measurement: - Time point 3: week 16 when the study ended
Secondary outcome [2] 319760 0
Self-efficacy assessed using the chronic disease self-efficacy 6-item scale (SES)
Timepoint [2] 319760 0
The outcome will be measured at time point 1: baseline
Repeated measurement: - Time point 2: week 8, Time point 3: week 16 when the study ended
Secondary outcome [3] 319761 0
Health related quality of life assessed by the Vietnamese language version of the SF-36v2.
Timepoint [3] 319761 0
The outcome will be measured at time point 1: baseline
Repeated measurement: - Time point 3: week 16 when the study ended

Eligibility
Key inclusion criteria
- People diagnosed with CKD stages 3-5 and not expected to start dialysis during the study
- Contactable via telephone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cannot communicate in Vietnamese
- People who are undertaking peritoneal dialysis or haemodialysis
- Significant cognitive impairment

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer generated allocation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation and opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated by using the G*Power 3.1 sample size calculation program with an effect size of 0.5 for Wilcoxon-Mann-Whitney test (two groups), a = 0.05, power of 80%, and allocation ratio N2/N1 is 1. The sample size is 134 participants (67 participants per group). However, allowing for an attrition rate of 20% (14 participants added per group), the sample has been increased to 162 participants in total (81 participants in the control group and 81 participants in the intervention group).
Data will be entered into and analysed using SPSS. The statistical analysis will involve independent t-test, paired t-test, Wilcoxon signed rank test, and two-way mixed analysis of variance (ANOVA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/11/2015
Date of last participant enrolment
Anticipated
31/01/2016
Actual
5/02/2016
Date of last data collection
Anticipated
Actual
3/06/2016
Sample size
Target
162
Accrual to date
Final
135
Recruitment outside Australia
Country [1] 7497 0
Viet Nam
State/province [1] 7497 0
Hanoi

Funding & Sponsors
Funding source category [1] 292630 0
Other Collaborative groups
Name [1] 292630 0
Australia Awards Scholarship
Country [1] 292630 0
Australia
Funding source category [2] 292681 0
University
Name [2] 292681 0
Queensland University of Technology
Country [2] 292681 0
Australia
Primary sponsor type
Individual
Name
Nguyen Thi Nguyet
Address
School of Nursing, Queensland University of Technology
N Block, Room 501
Victoria Park Rd
Kelvin Grove QLD 4059
Australia
Country
Viet Nam
Secondary sponsor category [1] 291410 0
None
Name [1] 291410 0
Address [1] 291410 0
Country [1] 291410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294112 0
Queensland University of Technology University Human Research Ethics Committee (EC00171)
Ethics committee address [1] 294112 0
Office of Research Ethics & Integrity
Level 4, 88 Musk Avenue, Kelvin Grove 4059.QLD
Ethics committee country [1] 294112 0
Australia
Date submitted for ethics approval [1] 294112 0
22/07/2015
Approval date [1] 294112 0
29/10/2015
Ethics approval number [1] 294112 0
UHREC1500000678

Summary
Brief summary
The aim of this study is to evaluate the effectiveness of a nurse-led intervention in changing the self-management behaviour of people with CKD in Vietnam. The expected study outcomes are improved chronic kidney disease self-management and chronic kidney disease specific knowledge, increased chronic disease self-efficacy levels, better blood pressure control and improved health related quality of life.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 696 696 0 0
/AnzctrAttachments/369848-ethics approval forms 29102015.pdf
Attachments [2] 697 697 0 0
/AnzctrAttachments/369848-ETH_Info-Consent_20151028.pdf
Attachments [3] 711 711 0 0
/AnzctrAttachments/369848-Research Flow Chart 2015.pdf
Attachments [4] 1347 1347 0 0
/AnzctrAttachments/369848-Ethics variation approved 1500000678.pdf (Ethics approval)

Contacts
Principal investigator
Name 62450 0
Ms Nguyen Thi Nguyet
Address 62450 0
School of Nursing, Queensland University of Technology
N Block, Room 501
Victoria Park Rd
Kelvin Grove QLD 4059
Australia
Country 62450 0
Australia
Phone 62450 0
+61731380280
Fax 62450 0
+617 3138 3814
Email 62450 0
[email protected]
Contact person for public queries
Name 62451 0
Ms Nguyen Thi Nguyet
Address 62451 0
School of Nursing, Queensland University of Technology
N Block, Room 501
Victoria Park Rd
Kelvin Grove QLD 4059
Australia
Country 62451 0
Australia
Phone 62451 0
+61731380280
Fax 62451 0
+617 3138 3814
Email 62451 0
[email protected]
Contact person for scientific queries
Name 62452 0
Ms Nguyen Thi Nguyet
Address 62452 0
School of Nursing, Queensland University of Technology
N Block, Room 501
Victoria Park Rd
Kelvin Grove QLD 4059
Australia
Country 62452 0
Australia
Phone 62452 0
+61731380280
Fax 62452 0
+617 3138 3814
Email 62452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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