Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000504112
Ethics application status
Approved
Date submitted
15/03/2019
Date registered
28/03/2019
Date last updated
28/03/2019
Date data sharing statement initially provided
28/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interventions to support Patient Activation for adults on hemoDialysis (IPAD Study)
Scientific title
The IPAD study: tailored educational and self-management Intervention to support Patient Activation in adults on hemoDialysis
Secondary ID [1] 297729 0
None
Universal Trial Number (UTN)
U1111-1230-1839
Trial acronym
IPAD Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 312056 0
Condition category
Condition code
Renal and Urogenital 310619 310619 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provide essential routine information on haemodialysis mechanism, symptom control, medication management, nutrition advice, fluid restriction, and coping methods; standard pamphlets and electronic resources

Materials: Pamphlets from Kidney Health Australia and from resources provided by Monash Health, namely:
Fluid Facts (Amgen)
Low Phosphate (Amgen)
Low Potassium - Fruit (Amgen)
Low Potassium - Vegetable (Amgen)
Calcium and phosphate balance with kidney disease fact sheet [Kidney Health Australia (KHA)]
Drink water instead (KHA)
Salt and your kidneys fact sheet (KHA)
Hyperphosphataemia (Shire)

One-on-one individual self-management training session conducted by trained nephrology nurses. The duration of the session depends on the participant's activation level; one hour for participants with low activation level and 30 minutes for highly activated participants.
Content includes;
1) introduction to the self-management concept
2) addressing the importance and benefits of self-management
3) forming an action plan based on the self-management theory, introducing a log book to record blood pressure, fluid intake, daily weight, medications and diet.

Follow-up phone calls with receptive interview techniques which encourage patient-initiated talk to address current concerns, goal settings, behavioural modifications, services utilizations

Interventions delivered by the researchers - dialysis nurses involved in the study

Delivery: face-to-face (initial session) followed by telephone interviews as remaining contacts

Number of times: as per protocol, minimum weekly for 4 weeks, gradually decreasing to fortnightly for 2 fortnights, then 1 month after that for 6 months for participants with lower activation levels. Interventions stop on the month following the fortnightly follow up for participants with high activation levels.
Duration: 25 weeks for low activation participants; 9 weeks for high activation participants

Interventions will be personalised to each individual in the intervention arm. This will occur by practicing motivational interview techniques to probe areas of concern from the participants, and in turn the interventions to be addressed on that particular follow up will be based on the participants' perceived problem list.

Intervention adherence not assessed. Effectiveness will be assessed by post-intervention PAM score at the end of the treatment period, which will be 18 months after enrolment to the study.

Location: Monash Medical Centre - Clayton VIC Australia 3168
Intervention code [1] 313969 0
Behaviour
Comparator / control treatment
Provide essential routine information on haemodialysis mechanism, symptom control, medication management, nutrition advice, fluid restriction, and coping methods; standard pamphlets and electronic resources
Materials: Pamphlets from Kidney Health Australia and from resources provided by Monash Health
Control group
Active

Outcomes
Primary outcome [1] 319470 0
Change in levels of activation

Instrument: Patient Activation Measrue (PAM-13)
Timepoint [1] 319470 0
6 months after enrolment in the study
Secondary outcome [1] 368308 0
Change in intradialytic weight gains

Instrument: dialysis weight observations
Timepoint [1] 368308 0
6, 12, 18 months after enrolment in the study
Secondary outcome [2] 368309 0
Change in systolic and diastolic blood pressure

Instrument: dialysis blood pressure monitoring
Timepoint [2] 368309 0
6, 12, 18 months after enrolment in the study
Secondary outcome [3] 368310 0
Change in episodes of hyperkalaemia
Definition: serum potassium levels of > 6 mmol/L

Instrument: serum urine electrolyte and creatinine measurement
Timepoint [3] 368310 0
6, 12, 18 months after enrolment in the study
Secondary outcome [4] 368311 0
Change in medication adherence

Instrument: Morisky medication adherence scale
Timepoint [4] 368311 0
12 months after enrolment in the study

Eligibility
Key inclusion criteria
Recent commencement of haemodialysis (within 3 months) haemodialysis at Monash Medical Centre (MMC) and being 18 years of age or over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment
Inability to speak fluently in English language
Diagnosis of acute kidney injury
Participants opting to go to private haemodialysis satellite units permanently
Being an established patient on haemodialysis (having been on hemodialysis for more than 3 months)

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 involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation
Factor used for stratification: participant's level of activation following the evaluation of the patient activation measure (PAM) -13 Survey. Activation levels are grouped into a low and high category. Low levels with PAM score < or equal to 55.1, and high levels with PAM score >55.1
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size is 100 per group, total of 200. This sample size is sufficient to detect differences in mean PAM of 6 points between the 2 groups (intervention and control) with 80% power at the 5% level of significance using a standard deviation of 14 after allowing for 10% attrition. An intention-to-treat analysis will be utilised throughout (Missing final scores will be replaced with the baseline value for that subject). Differences between groups will be tested for categorical variables using chi square. Independent t-tests will be performed on baseline and 6-monthly for primary and secondary outcomes, and ANCOVA will be used to correct for baseline differences. Statistical significance will be accepted if the p-value is <0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
30/03/2020
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
200
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302257 0
Hospital
Name [1] 302257 0
Monash Health
Country [1] 302257 0
Australia
Primary sponsor type
Individual
Name
Denise Fraginal
Address
Nephrology Department
Level 3
Monash Medical Centre
246 Clayton Rd Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 302117 0
None
Name [1] 302117 0
Address [1] 302117 0
Country [1] 302117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302933 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 302933 0
246 Clayton Rd Clayton VIC 3168
Ethics committee country [1] 302933 0
Australia
Date submitted for ethics approval [1] 302933 0
17/10/2017
Approval date [1] 302933 0
05/12/2017
Ethics approval number [1] 302933 0
HREC/17/MonH/502

Summary
Brief summary
This project aims to evaluate the impact of an intervention designed to improve activation on patient outcomes and investigate whether activation levels of patients on haemodialysis change overtime. This study will involve adult participants 18 years and over who are new to haemodialysis and commence at Monash Medical Centre. It will be a single centre, prospective participant blinded randomised controlled trial with 18 months follow up. Participants will be randomly distributed into a control and an intervention group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91890 0
Miss Denise Fraginal
Address 91890 0
Nephrology Department
Level 3
Monash Medical Centre Clayton
246 Clayton Rd Clayton VIC 3168
Country 91890 0
Australia
Phone 91890 0
+61 468674642
Fax 91890 0
Email 91890 0
[email protected]
Contact person for public queries
Name 91891 0
Denise Fraginal
Address 91891 0
Nephrology Department
Level 3
Monash Medical Centre Clayton
246 Clayton Rd Clayton VIC 3168
Country 91891 0
Australia
Phone 91891 0
+61 468674642
Fax 91891 0
Email 91891 0
[email protected]
Contact person for scientific queries
Name 91892 0
Edward Zimbudzi
Address 91892 0
Nephrology Department
Level 3
Monash Medical Centre Clayton
246 Clayton Rd Clayton VIC 3168
Country 91892 0
Australia
Phone 91892 0
+61 395943466
Fax 91892 0
Email 91892 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
To protect participant confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
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