Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001617358
Ethics application status
Not required
Date submitted
15/11/2017
Date registered
11/12/2017
Date last updated
24/10/2019
Date data sharing statement initially provided
19/11/2018
Date results information initially provided
24/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding how remote patient monitoring supports patients with end stage kidney disease uptake and sustainability of peritoneal dialysis.
Scientific title
Understanding how remote patient monitoring supports patients with end stage kidney disease uptake and sustainability of peritoneal dialysis.
Secondary ID [1] 293376 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 305500 0
Chronic kidney disease 305501 0
Condition category
Condition code
Renal and Urogenital 304752 304752 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
We will conduct a qualitative project involving clinicians who provide peritoneal dialysis care and patients who have experienced peritoneal dialysis and their caregivers in three dialysis centres in New Zealand.
We will use purposive sampling to recruit study participants, once identified they will be sent letter of invitation and informed consent form. If participants agree to participate, they will be contacted by researcher to arrange a time to be interviewed at a place of their convenience.
Face-to-face semi-structured interviews will be conducted with participants in their preferred locations (home or clinic room). Interviews will be recorded and transcribed verbatim.
We anticipate interviews will last between 30-60 minutes.
Intervention code [1] 299631 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303975 0
Determine factors related to remote patient monitoring that influence clinician (nephrologists and peritoneal dialysis nurses) practice at an individual and practice level (semi-structured interview study).
This outcome is assessed with data from semi-structured interviews. Data will be analysed using thematic analysis. This analysis will generate a number of themes that explore the enablers and barriers to use of remote patient monitoring.
Timepoint [1] 303975 0
At one year after trial commencement
Secondary outcome [1] 340591 0
Determine factors related to remote patient monitoring that support patient choice and maintenance of peritoneal dialysis (semi-structured interview study).
This outcome will be assessed with data from semi-structured interviews. Data will be analysed using thematic analysis. This analysis will generate themes that are related to the value of remote patient monitoring for patients and how this would support them to continue dialysis treatment at home.
Timepoint [1] 340591 0
At two years post trial commencement

Eligibility
Key inclusion criteria
Qualitative interviews (Clinicians)

The study population will comprise purposively sampled clinicians who care for patients on or contemplating peritoneal dialysis.

Key Inclusion Criteria:
1). Nephrologists or PD Nurses who regularly care for patients on PD
2). Pre-dialysis Nurses or Nephrologists who provide education regarding PD treatment
3). Have provided informed consent

Qualitative interviews (Patients)

The study population will comprise purposively sampled ESKD patients from at least 3 NZ renal units.

Key Inclusion Criteria:
1) Patients and caregivers over the age of 18 years
2) Patients who are currently or have been treated with peritoneal dialysis
3) Caregivers who are or have performed or assisted in peritoneal dialysis
4) Pre-dialysis patients who are considering peritoneal dialysis
5) Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Clinicians who do not regularly care or provide education for patients on or contemplating PD
- Patients or caregivers unable to provide informed consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Qualitative interviews: Qualitative research does not have specific guidelines for sample size, and the process of data saturation, defined as when there are no new data collected, will determine the number of participants.
• The anticipated number of clinician participants in this study sample will be between 10 and 15.
• The anticipated number of patient and caregiver participants in this study sample will be between 30-40.

Participant interviews will face-to-face and semi-structured. All interviews will be audio-recorded and transcribed verbatim. We will enter transcripts of interviews into HyperRESEARCH software (ResearchWare Inc, Version 2.8.3, United States), for line-by-line review by the study team. We will analyse data for emergent themes using the qualitative method of thematic analysis, to provide in-depth knowledge of their beliefs, understanding, experiences and perspectives of peritoneal dialysis and increased support through remote patient monitoring.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/02/2018
Actual
5/03/2018
Date of last participant enrolment
Anticipated
3/02/2020
Actual
29/03/2019
Date of last data collection
Anticipated
Actual
29/03/2019
Sample size
Target
45
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 9363 0
New Zealand
State/province [1] 9363 0

Funding & Sponsors
Funding source category [1] 298002 0
Commercial sector/Industry
Name [1] 298002 0
Baxter Healthcare Corporation
Country [1] 298002 0
United States of America
Primary sponsor type
Individual
Name
Rachael Walker
Address
Eastern Institute of Technology
510 Gloucester St
Taradale
Napier 4112
Country
New Zealand
Secondary sponsor category [1] 297067 0
None
Name [1] 297067 0
Address [1] 297067 0
Country [1] 297067 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 299039 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 299039 0
Ministry of Health, Health and Disability Ethics Committees PO Box 5013. Wellington 6140.
Ethics committee country [1] 299039 0
New Zealand
Date submitted for ethics approval [1] 299039 0
08/01/2018
Approval date [1] 299039 0
Ethics approval number [1] 299039 0

Summary
Brief summary
Supporting patients and clinicians to be confident with home treatment is one of the most important attributes influencing patient selection toward home dialysis. Our hypothesis is that remote patient monitoring for patients considering peritoneal dialysis can support patient decision-making, increase preferences for peritoneal dialysis and enhance treatment characteristics of peritoneal dialysis to align more closely with patient-centered care. To test this hypothesis, this study will explore patient and clinician perceptions of remote patient monitoring to support choosing and sustaining peritoneal dialysis as a treatment modality. The study will seek to understand clinician views of remote patient monitoring to establish how better to support clinicians to recommend peritoneal dialysis. Ultimately, if remote patient monitoring is identified to be acceptable to patients and clinicians, This study could then lead to rigorous testing of remote patient monitoring in clinical trials.

In this study we will conduct a qualitative project involving clinicians who provide peritoneal dialysis care and patients who have experienced peritoneal dialysis and their caregivers in three dialysis centres in New Zealand.

The study objectives are:

• Objective 1: Summarise the current evidence for experiences of patients and caregivers regarding remote patient monitoring (systematic review and thematic synthesis of qualitative studies).

• Objective 2: Determine factors related to remote patient monitoring that influence clinician (nephrologists and peritoneal dialysis nurses) practice at an individual and practice level (semi-structured interview study).

• Objective 3: Determine factors related to remote patient monitoring that support patient choice and maintenance of peritoneal dialysis (semi-structured interview study)

This study will advance knowledge about how remote patient monitoring supports patient choice and maintenance of peritoneal dialysis. This study will enable recommendations about remote patient monitoring in dialysis practice. The findings may encourage inclusion of remote patient monitoring to support uptake of peritoneal dialysis in lower income countries throughout Asia and the Western /Pacific regions for patients who may not have access to alternative dialysis treatments.
Trial website
Trial related presentations / publications
Public notes
Exemption for ethical approval was granted from HDEC as the study was deemed a minimal risk observational study. Localities approval (at each separate hospital is however required).

Contacts
Principal investigator
Name 79078 0
A/Prof Rachael C Walker
Address 79078 0
School of Nursing
Eastern Institute of Technology
504 Gloucester ST
Taradale, Napier 4112
Country 79078 0
New Zealand
Phone 79078 0
+64272349205
Fax 79078 0
Email 79078 0
[email protected]
Contact person for public queries
Name 79079 0
A/Prof Rachael Walker
Address 79079 0
School of Nursing
Eastern Institute of Technology
504 Gloucester ST
Taradale, Napier 4112
Country 79079 0
New Zealand
Phone 79079 0
+64272349205
Fax 79079 0
Email 79079 0
[email protected]
Contact person for scientific queries
Name 79080 0
A/Prof Rachael Walker
Address 79080 0
School of Nursing
Eastern Institute of Technology
504 Gloucester ST
Taradale, Napier 4112
Country 79080 0
New Zealand
Phone 79080 0
+64272349205
Fax 79080 0
Email 79080 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?




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.