Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000014550
Ethics application status
Approved
Date submitted
10/03/2014
Date registered
12/01/2015
Date last updated
12/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Motivational interviewing for people undergoing home dialysis to improve treatment adherence: A randomised controlled trial.
Scientific title
Motivational interviewing conducted by nurses for people undergoing home dialysis to improve treatment adherence: A randomised controlled trial.
Secondary ID [1] 283559 0
nil known
Universal Trial Number (UTN)
Trial acronym
MIA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with End Stage Kidney Disease (ESKD) on automated peritoneal dialysis and/or haemodialysis 290465 0
Condition category
Condition code
Renal and Urogenital 290857 290857 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention Group

Group 1, Motivational Interviewing intervention: Following completion of the questionnaire (10 minutes) and random allocation, each participant in Group 1 will receive information relating to their treatment from the registered nurse will conduct a once off 30 minutes interview, with Motivational Interviewing strategies using the 5As model. This model is designed to formally involve you in decision making about the education and information you receive for your care. Any other routine or usual care from the regular medical and nursing clinicians from the Home Independent Dialysis treatment service HIDTS will also be provided."
Intervention code [1] 288253 0
Behaviour
Comparator / control treatment
Group 2, the Control Group (Routine or Usual care): Following completion of the questionnaire and random allocation, each participant in Group 2 will receive an assessment along with written and verbal information using the usual education processes by the registered nurses from the HIDTS service. Any other routine or usual care from the regular medical and nursing clinicians from the HIDTS will also be provided.
Control group
Active

Outcomes
Primary outcome [1] 290854 0
Self-management of dialysis sessions (a composite outcome)as prescribed over 12 weeks as measured by the validated instrument, Strategies Used by People to Promote Health (SUPPH), Objective measurements including pathology results and treatment times for patients with ESKD.
Timepoint [1] 290854 0
Baseline, 6 weeks and 12 weeks
Secondary outcome [1] 311922 0
Diet and fluid adherence measured by the Morisky scale for Adherence for patients with ESKD.
Timepoint [1] 311922 0
Baseline, Week 6 and Week 12

Eligibility
Key inclusion criteria
Participants undergoing automated peritoneal dialysis, haemodialysis and ESKD patients who attend and or receive renal services from nurses of the Home Independent and Dialysis Treatment Services (HIDTS).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years of age

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)
About 72 participants are expected to participate in this study and the duration of participation is expected to be 12 weeks. Once consent has been obtained, the Renal Nurses will ring the off site randomiser. Participants will either be in the control group or the intervention. They will be randomly allocated into one of the two (2) groups:Group 1 (Motivational Interviewing Intervention) and Group 2 (Routine or Usual Care). Particpants and those providing the treatment will be blinded to the randomisation process. Participants will be blinded to the Intervention as they are unaware as to whom has been trained in the counselling intervention. The researcher is blinded to the data collection and input.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software will randomly allocate the participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Sample Size: To see a minimum clinical difference of 15 points on the primary outcome measure the SUPPH (self-efficacy scale) with a standard deviation of 10, using a 5% level of significance and 80% power, 36 patients per group was required. That is 36 in the intervention and 36 in the control groups.

Data Analysis: All statistical data will be analysed using SPSS. Categorical data will be expressed as frequencies and percentages. Fisher’s exact test and logistic regression will be used to compare differences between groups. Continuous data will be expressed as the difference between 12 weeks and baseline, and will be described by means and standard deviations. ANOVA and t-tests will be used to analyse the relationships between two or more groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2013
Actual
31/10/2013
Date of last participant enrolment
Anticipated
1/04/2014
Actual
3/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2179 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 9039 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 288328 0
Charities/Societies/Foundations
Name [1] 288328 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 288328 0
Australia
Primary sponsor type
Individual
Name
Carol Reid
Address
School of Nursing
Queensland University of Technology
Victoria Park Rd, Kelvin grove, 4171
Brisbane, QLD
Country
Australia
Secondary sponsor category [1] 288893 0
None
Name [1] 288893 0
Address [1] 288893 0
Country [1] 288893 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Psycho-educational support is recommended as essential for patients undertaking self-management of their dialysis treatment An intervention such as motivational interviewing (MI), the use of the 5 As model and information giving from nurses may promote behavioural change to enhance adherence to prescribed treatments and to reduce risk factors associated with severe life threatening medical complications. This randomized controlled trial will examine the effectiveness of this intervention for people with ESKD and who live at home, undergoing either automated peritoneal dialysis or haemodialysis. This intervention may improve adherence to dialysis session times; fluid and dietary intake, diet and taking prescribed medications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44182 0
Dr Carol Reid
Address 44182 0
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country 44182 0
Australia
Phone 44182 0
61 7 31389607
Fax 44182 0
Email 44182 0
[email protected]
Contact person for public queries
Name 44183 0
Carol Reid
Address 44183 0
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country 44183 0
Australia
Phone 44183 0
61 7 31389607
Fax 44183 0
Email 44183 0
[email protected]
Contact person for scientific queries
Name 44184 0
Carol Reid
Address 44184 0
Queensland University of Technology
Victoria Park Rd
Kelvin Grove, 4029
Queensland
Country 44184 0
Australia
Phone 44184 0
61 7 31389607
Fax 44184 0
Email 44184 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.