Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001316998
Ethics application status
Approved
Date submitted
2/11/2020
Date registered
7/12/2020
Date last updated
22/12/2021
Date data sharing statement initially provided
7/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using mobile phone technology to understand fatigue, mood and activity levels in patients receiving peritoneal dialysis
Scientific title
Ecological momentary assessment to explore fatigue, mood and physical activity levels in people receiving peritoneal dialysis
Secondary ID [1] 302672 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with end stage kidney disease receiving peritoneal dialysis 319591 0
Condition category
Condition code
Renal and Urogenital 317530 317530 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
People receiving peritoneal dialysis will complete surveys asking about their fatigue and mood experienced at five separate time points per day for a seven-day period using ecological momentary assessment. The time points are; Wake up, bed time and, semi randomly between 10am-1pm, 1pm-4pm and 4pm-7pm. Each survey session should take approximately 5mins to complete.

They will concurrently wear an accelerometer which will collect data relating to their physical activity levels for the same 7-day period.
Intervention code [1] 318955 0
Not applicable
Comparator / control treatment
No comparator or control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325572 0
Fatigue as measured via the Visual Analogue Scale to Evaluate Fatigue Severity instrument.
Timepoint [1] 325572 0
Five times daily for a period of seven days:
Wake-up
10am-1pm (semi-randomly)
1pm-4pm (semi-randomly)
4pm-7pm (semi-randomly)
Bedtime
Primary outcome [2] 325573 0
Mood as measured via the Visual Analogue Mood Scale instrument
Timepoint [2] 325573 0
Five times daily for a period of seven days:
Wake-up
10am-1pm (semi-randomly)
1pm-4pm (semi-randomly)
4pm-7pm (semi-randomly)
Bedtime
Primary outcome [3] 325574 0
Physical activity measured via accelerometery
Timepoint [3] 325574 0
Worn continuously for the concurrent seven-day period that fatigue and mood is measured
Secondary outcome [1] 388411 0
Feasibility and Acceptability measured via:
1. Lag-times (i.e. participants’ response time from mobile application prompt to completion of the prompt) and
2. Number of completed prompts
3. A completion survey that was designed specifically for this study, adapted from previous studies, with themes including mobile ease of use, convenience and whether participants consider mobile EMA to have potential to explore other areas of concern for people receiving peritoneal dialysis (e.g. diet, dyspnea, quality of life).
Timepoint [1] 388411 0
Day after the seven-day period has concluded

Eligibility
Key inclusion criteria
1. Over 18 years of age
2. Receiving a form of peritoneal dialysis in South Australia
3. Independently ambulant (including use of aids such as walking stick, crutches, four-wheel walker etc.)
4. Active e-mail (or be willing to create one)
5. Able to use a mobile phone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to give written consent
2. Unable to understand English or have adequate translator services available.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
It is anticipated a recruitment rate of ~50% will be achieved. There are currently 106 eligible people within the clinical catchment. This sample size (n=55) will give ~60% power to detect a moderate effect size and ~90% power to detect a large effect size (EMA tools package R), based on: the number of study days and prompts per day outlined in the procedure above; assuming that, on average, participants will respond to 75% of the prompts; and conservatively estimating that between-subject variability in the momentary experience of fatigue is no higher than 50%.

Descriptive statistics will be used to describe the cohort demographics. Multilevel linear regression modelling will be used to investigate: if fatigue fluctuates throughout the day, with time as the independent variable and fatigue scores as the dependent variable; the temporal associations between fatigue and mood at wake up and subsequent activity levels of the same day (1pm - 7pm); and inversely, the activity levels during the day (10am – 4pm) and subsequent fatigue and mood scores at bed time; the temporal associations between the activity levels in the 30 minutes preceding and following the survey prompt and, fatigue and mood scores at the time of the prompt. Moderate-to-vigorous intensity physical activity levels and total physical activity levels (min)will both be considered in these analyses. All analyses will be adjusted for age, sex. Descriptive statistics will be used to report the quantitative data (e.g. Likert scales) and narrative synthesis for the qualitative elements of the participant feasibility/acceptability survey. Descriptive statistics will further describe the reach (i.e. proportion of eligible participants who agreed to take part in the study); the compliance (i.e. proportion of prompts answered on time by participants and mean lag times); and the proportion of participants who withdrew from the study with narrative synthesis to describe the reasons for withdrawal. Statistical analysis will be completed using Stata Version 16 (StataCorp, College Station, TX) and R Version 3.6.3.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
55
Accrual to date
39
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307111 0
Other Collaborative groups
Name [1] 307111 0
University of South Australia, The Hospital Research Foundation and SA Health, Allied Health Research Collaboration Funding 2019.
Country [1] 307111 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Allied Health and Human Performance
101 Currie St, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 307682 0
Government body
Name [1] 307682 0
SA Health
Address [1] 307682 0
11 Hindmarsh Square, Adelaide SA 5000
Country [1] 307682 0
Australia
Secondary sponsor category [2] 307686 0
Charities/Societies/Foundations
Name [2] 307686 0
The Hospital Research Foundation
Address [2] 307686 0
62 Woodville Rd, Woodville South SA 5011
Country [2] 307686 0
Australia
Other collaborator category [1] 281525 0
Government body
Name [1] 281525 0
The Central and Northern Renal and Transplantation Service - Clinical Research Group
Address [1] 281525 0
Royal Adelaide Hospital
Port Rd, Adelaide SA 5000
Country [1] 281525 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307226 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307226 0
The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 50110
Ethics committee country [1] 307226 0
Australia
Date submitted for ethics approval [1] 307226 0
13/05/2020
Approval date [1] 307226 0
24/07/2020
Ethics approval number [1] 307226 0
13245

Summary
Brief summary
This research aims to explore the relationships between mood, fatigue and physical activity through the use of a novel mobile application (ecological momentary assessment (mEMA)). mEMA is a survey method that allows data collection of participants’ behaviours, mood and perceptual experiences in real-time (momentary) and in real-life environments (ecological).

Patients receiving peritoneal dialysis will be recruited from within the CNARTS catchment.
This will be a intensive longitudinal observation design. Consenting participants will be met at home or during a routine clinical appointment to assist with download of the mobile app (free to participants) and instruction on correct use of this application. The application will prompt users to answer a set of pre-set questions relating to mood, fatigue at five times each day for seven days. Participants will also be asked to wear a accelerometer for the same seven day period. Accelerometers are highly valid and an objective measure of physical activity levels.

The overarching research aims are to explore in real-time how fatigue levels fluctuate throughout the day, and to investigate the associations between mood and physical activity levels and fatigue in people with ESKD receiving peritoneal dialysis. The secondary aim is to explore the feasibility of using EMA in this population
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106470 0
Mr Brett Tarca
Address 106470 0
Att: Brett Tarca (P2-42A)
University of South Australia
Reply Paid 2471
Adelaide, SA 5001
Country 106470 0
Australia
Phone 106470 0
+61 8 8302 2906
Fax 106470 0
Email 106470 0
[email protected]
Contact person for public queries
Name 106471 0
Mr Brett Tarca
Address 106471 0
Att: Brett Tarca (P2-42A)
University of South Australia
Reply Paid 2471
Adelaide, SA 5001
Country 106471 0
Australia
Phone 106471 0
+61 8 8302 2906
Fax 106471 0
Email 106471 0
[email protected]
Contact person for scientific queries
Name 106472 0
Mr Brett Tarca
Address 106472 0
Att: Brett Tarca (P2-42A)
University of South Australia
Reply Paid 2471
Adelaide, SA 5001
Country 106472 0
Australia
Phone 106472 0
+61 8 8302 2906
Fax 106472 0
Email 106472 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
Participants will be provided individual data pertaining to their own scores during the study period. However, our ethics protocol stipulates that no individual data (including de-identified data) will be made available outside of this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9591Informed consent form    380853-(Uploaded-02-11-2020-11-09-04)-Study-related document.docx



Results publications and other study-related documents

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