Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000190202
Ethics application status
Approved
Date submitted
8/01/2018
Date registered
7/02/2018
Date last updated
7/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multidisciplinary assessment at dialysis entry (MADE) study
Scientific title
Multidisciplinary assessment at dialysis entry (MADE) study measuring quality of life, psychological, gastrointestinal, nutritional, frailty and health literacy measures in patients with end stage kidney disease commencing haemodialysis or peritoneal dialysis
Secondary ID [1] 293725 0
None
Universal Trial Number (UTN)
Trial acronym
MADE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 306079 0
Haemodialysis 306080 0
Peritoneal Dialysis 306081 0
Condition category
Condition code
Renal and Urogenital 305213 305213 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Survey of participants at the commencement of dialysis with follow up surveys at 3 and 6 months. The survey includes a 159 item questionnaire and 2 physical function tests. The questionnaire is paper based, given to the participant by a researcher when they attend dialysis and collected the next dialysis treatment 2 days following. The participant completes it independently. The questionnaire combines 12 validated questionnaires. The two physical function tests are grip strength as measured by dynamometer and 3 metre up and go test. Each test takes 2 minutes to complete and is undertaken in the dialysis clinic prior to the patient attending dialysis. There is no intervention in this study.
Intervention code [1] 299976 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304368 0
Quality of Life change as measured Integrated Palliative care Outcome Scale (IPOS Renal)
Timepoint [1] 304368 0
0, 3 and 6 months
Primary time point is 6 months
Secondary outcome [1] 341751 0
Depression, Anxiety and Stress as measured by the Depression, Anxiety and Stress Scale (DASS21) and the Emotional Thermometer
Timepoint [1] 341751 0
0, 3 and 6 months
Secondary outcome [2] 341753 0
Illness Perception as measured by the Brief Illness Perception Questionnaire (BILP)
Timepoint [2] 341753 0
0, 3 and 6 months
Secondary outcome [3] 341754 0
Coping Abilities as measure by the "Brief COPE' scale
Timepoint [3] 341754 0
0,3 and 6 months
Secondary outcome [4] 341755 0
Perceptions of Illness Intrusion as measured by the Illness Intrusive Rating Scale
Timepoint [4] 341755 0
0,3 and 6 months
Secondary outcome [5] 342520 0
Dietary Habits as measured by the Weekly Food Checklist
Timepoint [5] 342520 0
0, 3 and 6 months
Secondary outcome [6] 342521 0
Gastrointestinal Health as measured by the Gastrointestinal Symptom Rating Scale (GSRS) and Bristol Stool Chart
Timepoint [6] 342521 0
0, 3 and 6 months
Secondary outcome [7] 342522 0
Sleep Quality as measured by the The Pittsburgh Sleep Quality Index (PSQI)
Timepoint [7] 342522 0
0. 3 and 6 months
Secondary outcome [8] 342523 0
Medication Adherence as measured by the Morisky Medication Adherence Scale
Timepoint [8] 342523 0
0, 3 and 6 months
Secondary outcome [9] 342524 0
Health literacy as measured by the BRIEF Health Literacy Screening Tool.
Timepoint [9] 342524 0
0, 3 and 6 months
Secondary outcome [10] 342525 0
Cognition as measured by the Montreal Cognitive Assessment (MOCA) Tool
Timepoint [10] 342525 0
0, 3 and 6 months
Secondary outcome [11] 342769 0
Physical function as measured by the 3 meter up and go test
Timepoint [11] 342769 0
0, 3 and 6 moths
Secondary outcome [12] 342770 0
Grip Strength as measured by Dynamometer
Timepoint [12] 342770 0
0,3 and 6 months

Eligibility
Key inclusion criteria
1. End Stage Kidney Disease
2. Commencing haemodialysis or peritoneal dialysis
3. Commencing in the Central Northern Area Renal and Transplant Service (CNARTS)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute Kidney Disease only
2. Commencing dialysis in a rural clinic
3. Unable to understand English

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Categorical data will be analysed using chi-squared tests (or Fisher’s exact test for small samples). This data will be analysed using a repeated measures analysis of variance (ANOVA) with time being the dependent variable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/12/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
160
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9690 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 9691 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 9692 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 18459 0
5000 - Adelaide
Recruitment postcode(s) [2] 18460 0
5011 - Woodville
Recruitment postcode(s) [3] 18461 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 298340 0
Charities/Societies/Foundations
Name [1] 298340 0
Kidney, Transplant & Diabetes Research Australia (KTDRA)
Country [1] 298340 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
1 Port Road, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 297675 0
None
Name [1] 297675 0
None
Address [1] 297675 0
Country [1] 297675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299332 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 299332 0
Level 4, Women’s Health CentreRoyal Adelaide Hospital North TerraceAdelaide, South Australia, 5000
Ethics committee country [1] 299332 0
Australia
Date submitted for ethics approval [1] 299332 0
24/10/2017
Approval date [1] 299332 0
31/10/2017
Ethics approval number [1] 299332 0
HREC/17/RAH/467

Summary
Brief summary
The aim of the study is to better identify the care needs of individuals with end stage kidney disease commencing dialysis. Commencing dialysis impacts individuals beyond their physical health. Participants will be asked to complete a questionnaire and undergo physical function tests over the first 6 months of their dialysis treatment. Quality of life, psychological and physical function, gastro-intestinal health, nutrition and health literacy will be measured. Results of this study will help inform the development of this standard protocol and allow for modifications to be developed to address the needs of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80086 0
Dr Shilpa Jesudason
Address 80086 0
Room 7F401, Royal Adelaide Hospital, 1 Port Road, Adelaide, SA, 5000
Country 80086 0
Australia
Phone 80086 0
+61870742558
Fax 80086 0
Email 80086 0
Shilpa.jesudason@sa.gov.au
Contact person for public queries
Name 80087 0
Prof Paul Bennett
Address 80087 0
7F401, Royal Adelaide Hospital, 1 Port Road, Adelaide, SA, 5000
Country 80087 0
Australia
Phone 80087 0
+61870742558
Fax 80087 0
Email 80087 0
p.bennett@deakin.edu.au
Contact person for scientific queries
Name 80088 0
Prof Paul Bennett
Address 80088 0
7F401, Royal Adelaide Hospital, 1 Port Road, Adelaide, SA, 5000
Country 80088 0
Australia
Phone 80088 0
+61870742558
Fax 80088 0
Email 80088 0
p.bennett@deakin.edu.au

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

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Documents added automatically
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