Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000560392
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
21/04/2017
Date last updated
1/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Keeping on Track: exploring the activity levels and use of healthcare services of patients after discharge from hospital for a cardiac event.
Scientific title
Keeping on Track: exploring the activity levels and utilisation of healthcare services of patients in the first 30 and 90 days after discharge from hospital for a cardiac event, comparing patients who live in areas with high and low levels of access to health care services.
Secondary ID [1] 291564 0
Heart Foundation 2016 Vanguard Grant, Award ID: 101443
Universal Trial Number (UTN)
U1111-1194-8359
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 302660 0
Condition category
Condition code
Cardiovascular 302178 302178 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Brief Name
Using a phone with tracking and activity software to objectively measure activity levels and utilization of local health care resources after discharge following Acute Coronary Syndrome (ACS).

Why
The use of measured data, rather than self-report or using clinical outcomes as a proxy, over a longer time period will provide the first objective insight into cardiac patients activities immediately following discharge, and whether these align with the discharge education they received before they left hospital.

What
Prior to discharge, participants will be provided with a Samsung Galaxy J1 mini mobile phone (or similar), equipped with a data-only SIM card and loaded with a pedometer (step counting) app and a GPS tracking app.
Accessories will include the charging cable and armband to carry the phone in that position if desired. The study nurse will activate the phone and instruct the participant on how to charge it; written instructions will also be supplied. The participants are not expected to interact with the phone except for wearing and charging.

Procedures
Participants will be asked to carry the phone during waking hours for the duration of the study and charge it every night.
The study nurse will call each participant once a week to check that they are not having any problems with the phone. If requested they will also provide a summary of the participants step count for the previous week. A short questionnaire will also be administered at this time, and a slightly longer one after the first 4 weeks and at the end of the study.
At the week 4 call the participant will be asked if they wish continue with the study- if no they will be informed that there is no penalty with stopping at that point and thanked for their participation. Participants will be able to keep the phone on completion of the study.

Who provided
An experienced Registered Nurse and/or Aboriginal Liaison Officer will be trained on the operation of the phone and apps and the conduct of the interviews.

How
Initial recruitment, baseline data collection and provision and activation of the phone will be conducted face to face. All further contact will be by telephone.

Where
Recruitment will occur in two major Adelaide metropolitan hospitals.
Monitoring will occur in the participants homes and communities as they go about their usual daily activities. Data from the GPS will only be analysed when it occurs at health service locations previously agreed to by the participant.

When and how much
Data will be recorded continuously during waking hours for a period of at least 30 days and up to 90 days from enrollment.

How well
Correlation of the recorded activity with that reported during the weekly phone contact will be performed to assess adherence.
Intervention code [1] 297629 0
Not applicable
Comparator / control treatment
Comparisons will be made Aboriginal and non-Aboriginal participants, and between participants who reside in metropolitan areas and participants who reside in rural/remote areas.
Control group
Active

Outcomes
Primary outcome [1] 301604 0
Physical activity in accordance with the Heart Foundation guidelines, measured by a pedometer application.
Timepoint [1] 301604 0
30 days and 90 days post discharge from hospital.
Primary outcome [2] 301822 0
Use of primary health care services (general practice, pharmacy, etc) as recommended at discharge, measured using GPS tracking application.
Timepoint [2] 301822 0
30 days and 90 days post discharge from hospital.
Secondary outcome [1] 333276 0
Acceptability to participants and utility of activity data collection using mobile telephone applications.
Timepoint [1] 333276 0
30 days and 90 days post discharge from hospital.

Eligibility
Key inclusion criteria
1. Has a confirmed diagnosis of ACS
2. Is at least 18 years of age and able to give consent
3. Is able to speak, read and understand English
4. Is willing to carry the phone for at least 30 days
5. Must be able to receive a weekly phone call
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has cognitive impairment
2. Is unable to participate in physical activity
3. Has been admitted previously with ACS
4. Is clinically unstable

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Up to 20 participants will be recruited- it is intended that the final cohort will include 10 metropolitan and 10 rural/remote participants, 5 of each will be of Aboriginal and Torres Strait Islander descent. Due to the exploratory nature and limited funding, the results will not be generalisable however they will be used to inform a future larger scale investigation.
Summarised spatial data and personal variables will be analysed using IBM SPSS Statistics 22. Intergroup differences will be analysed using cross tabulation with chi square testing for significance.
Geographic Information Systems software (ESRI ArcMap v10.3) will be used to analyse the spatial information.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
23/06/2017
Date of last participant enrolment
Anticipated
30/09/2017
Actual
30/10/2017
Date of last data collection
Anticipated
31/01/2018
Actual
Sample size
Target
20
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7743 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 7744 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 15673 0
5000 - Adelaide
Recruitment postcode(s) [2] 15674 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 296052 0
Charities/Societies/Foundations
Name [1] 296052 0
Heart Foundation
Country [1] 296052 0
Australia
Primary sponsor type
Individual
Name
Professor Robyn Clark
Address
School of Nursing and Midwifery, Flinders University
Room N212 Sturt Campus North Wing
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 294971 0
None
Name [1] 294971 0
None
Address [1] 294971 0
None
Country [1] 294971 0
Other collaborator category [1] 279512 0
Individual
Name [1] 279512 0
Dr. Peter Steele
Address [1] 279512 0
The Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 279512 0
Australia
Other collaborator category [2] 279513 0
Individual
Name [2] 279513 0
A/Professor Margaret Arstall
Address [2] 279513 0
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale
SA 5112
Country [2] 279513 0
Australia
Other collaborator category [3] 279514 0
Individual
Name [3] 279514 0
Professor Alex Brown
Address [3] 279514 0
Wardliparingga Aboriginal Research Unit
South Australian Health and Medical Research Institute
SAHMRI, PO BOX 11060
Adelaide
SA 5001
Country [3] 279514 0
Australia
Other collaborator category [4] 279515 0
Individual
Name [4] 279515 0
Professor Mark Daniel
Address [4] 279515 0
University of Canberra
University Drive, 22B35
Bruce
ACT 2601
Country [4] 279515 0
Australia
Other collaborator category [5] 279516 0
Individual
Name [5] 279516 0
Professor Neil Coffee
Address [5] 279516 0
University of Canberra
University Drive, 22B35
Bruce
ACT 2601
Country [5] 279516 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297309 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 297309 0
Level 4, Women’s Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 297309 0
Australia
Date submitted for ethics approval [1] 297309 0
21/02/2017
Approval date [1] 297309 0
22/03/2017
Ethics approval number [1] 297309 0
HREC/17/RAH/58 and R20170222
Ethics committee name [2] 297337 0
Aboriginal Health Research Ethics Committee
Ethics committee address [2] 297337 0
220 Franklin Street,
Adelaide SA 5000
Ethics committee country [2] 297337 0
Australia
Date submitted for ethics approval [2] 297337 0
23/02/2017
Approval date [2] 297337 0
24/03/2017
Ethics approval number [2] 297337 0
04-17-714

Summary
Brief summary
The aim of this study is to investigate the impact of discharge education and the use of patient resources in patients that have had a heart attack or unstable angina when they return home.
We will explore if patients actually follow the recommended activity guidelines and use of healthcare services such as cardiac rehabilitation, pharmacy, general practice, pathology and emergency department in the first 30 up to 90 days after discharge from hospital. Patients who live in areas with high and low levels of access to cardiac services will be compared with each other.
Outcomes will be assessed with the use of Global Positioning Systems (GPS) and Geographic Information Systems (GIS).
Participants who agree to participate will be educated on the use of a phone which they will be asked to carry for at least 30 days.
Participants will receive weekly phone calls for the duration of the study during which the nurse will ask a series of questions about their experiences with the phone and will ask about the health service locations that have been visited.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73662 0
Prof Robyn Clark
Address 73662 0
School of Nursing and Midwifery, Flinders University
Room N212 Sturt Campus North Wing
Bedford Park SA 5042
Country 73662 0
Australia
Phone 73662 0
+61 8 8201 3266
Fax 73662 0
Email 73662 0
[email protected]
Contact person for public queries
Name 73663 0
Dr Julie Franzon
Address 73663 0
School of Nursing and Midwifery, Flinders University
Room N204 Sturt Campus North Wing
Bedford Park SA 5042
Country 73663 0
Australia
Phone 73663 0
+61 8 8201 3066
Fax 73663 0
Email 73663 0
[email protected]
Contact person for scientific queries
Name 73664 0
Prof Robyn Clark
Address 73664 0
School of Nursing and Midwifery, Flinders University
Room N204 Sturt Campus North Wing
Bedford Park SA 5042
Country 73664 0
Australia
Phone 73664 0
+61 8 8201 3066
Fax 73664 0
Email 73664 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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