Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001085662
Ethics application status
Approved
Date submitted
18/09/2023
Date registered
16/10/2023
Date last updated
16/10/2023
Date data sharing statement initially provided
16/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-management intervention targeting health literacy, self-management and fluid adherence in people receiving haemodialysis in Sri Lanka: A feasibility cluster randomised controlled trial
Scientific title
Health Literacy Tailored Self-Management Intervention Targeting Fluid Adherence in People Receiving Haemodialysis in Sri Lanka: A Feasibility Cluster Randomised Controlled Trial
Secondary ID [1] 310619 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney failure 331500 0
haemodialysis 331625 0
Condition category
Condition code
Renal and Urogenital 328236 328236 0 0
Kidney disease
Public Health 328353 328353 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The self-management intervention involves four face-to-face individual teach-back sessions of 30-40 minutes over a 12-week period using a written education booklet (My guide for salt and fluid for kidney health). A nurse will talk through a section of the education booklet and ask an individual to explain in their own words, what the healthcare professional has taught them. If the learner is unable to communicate the information that has been provided, the information provider repeats the information until understanding is achieved. Use of teach-back in self-management teaching enhances the development of progressive achievement and independence through verbal persuasion as feedback is immediate. The booklet explains understanding kidney failure, overview of haemodialysis treatment, importance of fluid and sodium management, tips to control thirst, healthy foods to eat, meal planning and cooking tips, reading food labels, and what to do in social events. Additionally, supplementary documents includes patient stories, healthy foods to eat, sample meal plan, sample grocery list, curry powder recipies, low salt recipes, remedies to manage symptoms at home, and misperception about salt reduction. The written education booklet and supplementary documents have been developed by the research team, which has experts in the field of renal care and chronic disease self-management. In addition, a “fluid pack” including a bathroom scale to measure weight, measuring cup, spoon to measure the amount of liquid they are drinking, will be provided. Educational sessions are provided during routine haemodialysis treatment by a registered nurse in week 1, 3, 5 of the intervention, followed by one booster session at week 9. Participants in this intervention arm will receive both the standard care plus the intervention. Standard care involves a brief face-to-face 10 minutes education session that pertains to vascular access care, lifestyle modification, drug management, dietary and fluid restriction by a nursing officer after each HD treatment session.
Intervention code [1] 327022 0
Behaviour
Intervention code [2] 327023 0
Lifestyle
Comparator / control treatment
Participants randomised to the control group will receive standard care provided by healthcare providers. Standard care involves a brief face-to-face 1o minutes education session that pertains to vascular access care, lifestyle modification, drug management, dietary and fluid restriction by a nursing officer after each haemodialysis (HD) treatment session (once weekly). The education will be administered verbally using a readily available leaflet.
Control group
Active

Outcomes
Primary outcome [1] 336102 0
Feasibility
Timepoint [1] 336102 0
At the conclusion of study
Primary outcome [2] 336103 0
Acceptability
Timepoint [2] 336103 0
At 12 weeks after intervention commencement
Secondary outcome [1] 426836 0
Interdialytic weight gain
Timepoint [1] 426836 0
Baseline and weekly during the intervention period
Secondary outcome [2] 426837 0
Blood pressure
Timepoint [2] 426837 0
Baseline and weekly during the intervention period
Secondary outcome [3] 426838 0
Knowledge on fluid and sodium management in kidney failure. This will be assessed as a composite outcome.
Timepoint [3] 426838 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [4] 426839 0
Self-Care
Timepoint [4] 426839 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [5] 426840 0
Self-efficacy
Timepoint [5] 426840 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [6] 426841 0
Health-related quality of life
Timepoint [6] 426841 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [7] 426842 0
Health literacy
Timepoint [7] 426842 0
Baseline and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
Adults (18 years of age and over) with kidney failure undergoing HD treatment (a minimum of one time per week) for at least 3 months.


Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those on peritoneal dialysis, unable to speak and understand Sinhala, unable to provide informed consent, have a mental health condition, and/or impaired cognitive status that prevents the understanding of information, and people who are undergoing temporary HD for acute kidney injury.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participant will be randomised on 1:1 ratio according to treatment shifts (treatment days). Simple randomisation using procedures like coin-tossing and dice-rolling.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Due to the feasibility nature of the study, a priori power analysis is not required as the primary outcomes of this study are not dependent on effect sizes. According to the recommendations for feasibility trials, a sample size of 20 in each group is required to accomplish the goal of feasibility. This number has been inflated to allow for 25% drop-out rate. In total 50 participants (25 per arm) are needed for this study.
Primary outcomes will assess feasibility of recruitment, retention, questionnaire completion and acceptability of the intervention. These will be expressed as frequency and percentages. Demographic and renal characteristics will be expressed counts and percentages or means and standard deviation for normally distributed variables. Continuous variable will be compared between two groups using t-tests or Wilcoxon tests according to their distribution. Statistical significance set at a =0.05. The analysis will follow the principle of “intention-to-treat analysis” using the last data carried forward. Effect size for the secondary outcome measures will be explored using repeated measures analysis of variance (ANOVA) and effect size calculated using partial eta squared. Repeated measures ANOVA will be used with factors of group (standard care/ self-management intervention) and time (preintervention/postintervention) that enable for overall comparison between the two groups. If outcome data are not normally distributed, then differences will be assessed using transformed data or appropriate non-parametric tests. Mean differences in outcomes between two groups will be expressed with 95% CIs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/10/2023
Actual
Date of last participant enrolment
Anticipated
16/11/2023
Actual
Date of last data collection
Anticipated
16/02/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25774 0
Sri Lanka
State/province [1] 25774 0
Southern

Funding & Sponsors
Funding source category [1] 314836 0
University
Name [1] 314836 0
Griffith University
Country [1] 314836 0
Australia
Primary sponsor type
University
Name
Griffith University (School of Nursing and Midwifery)
Address
School of Nursing and Midwifery, Griffith University, 170 Kessels road, Nathan, Brisbane, Queensland, 4111 Australia
Country
Australia
Secondary sponsor category [1] 317043 0
None
Name [1] 317043 0
Address [1] 317043 0
Country [1] 317043 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313837 0
Ethics review committee, Faculty of Allied Health Sciences, University of Ruhuna, Sri Lanka
Ethics committee address [1] 313837 0
Faculty of Allied Health Sciences, Godakanda, Karapitiya, Galle, Sri Lanka
Ethics committee country [1] 313837 0
Sri Lanka
Date submitted for ethics approval [1] 313837 0
22/03/2023
Approval date [1] 313837 0
18/08/2023
Ethics approval number [1] 313837 0
220.03.2023
Ethics committee name [2] 313838 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 313838 0
School of Nursing and Midwifery, Griffith University, 170 Kessels road, Nathan, Brisbane, Queensland, 4111, Australia
Ethics committee country [2] 313838 0
Australia
Date submitted for ethics approval [2] 313838 0
31/08/2023
Approval date [2] 313838 0
14/09/2023
Ethics approval number [2] 313838 0
2023/721

Summary
Brief summary
The aim of the study is to evaluate the feasibility and acceptability of conducting a pragmatic cluster randomised trial of an intervention to improve health literacy, self-management and fluid adherence in people receiving haemodialysis in Sri Lanka.This is a two-arm pragmatic cluster randomised controlled trial with 1:1 allocation with a 12-week intervention duration. Participants assigned to the intervention group will receive both the standard care plus the intervention, while participants randomised to the control group will receive standard care provided by healthcare providers. Primary outcomes (feasibility and acceptability) will be measured at 12 weeks. Both objective and patient-reported measures are used to assess secondary outcomes. Subjective outcomes (knowledge on fluid and salt control in kidney failure, self-efficacy, self-care index of kidney failure, self-efficacy for managing chronic disease, health-related quality of life, health literacy) will be collected at baseline and at 12 weeks. Objective outcomes (blood pressure and interdialytic weight) will be measured at baseline will be measured at baseline and every week throughout the intervention period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129506 0
Mrs Hemamali Madhushanthi Hirimbura Jagodage
Address 129506 0
N 48, School of Nursing and Midwifery, Griffith University, 170 Kessels road, Nathan, Brisbane, Queensland, 4111, Australia
Country 129506 0
Australia
Phone 129506 0
+61 0478694036
Fax 129506 0
Email 129506 0
[email protected]
Contact person for public queries
Name 129507 0
Mrs Hemamali Madhushanthi Hirimbura Jagodage
Address 129507 0
N 48, School of Nursing and Midwifery, Griffith University, 170 Kessels road, Nathan, Brisbane, Queensland, 4111, Australia
Country 129507 0
Australia
Phone 129507 0
+61 0478694036
Fax 129507 0
Email 129507 0
[email protected]
Contact person for scientific queries
Name 129508 0
Mrs Hemamali Madhushanthi Hirimbura Jagodage
Address 129508 0
N 48, School of Nursing and Midwifery, Griffith University, 170 Kessels road, Nathan, Brisbane, Queensland, 4111, Australia
Country 129508 0
Australia
Phone 129508 0
+61 0478694036
Fax 129508 0
Email 129508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20385Ethical approval  [email protected]
20386Informed consent form  [email protected]
20387Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.