Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001125617
Ethics application status
Approved
Date submitted
5/09/2023
Date registered
31/10/2023
Date last updated
31/10/2023
Date data sharing statement initially provided
31/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
safe@home: effectiveness and cost effectiveness of telemonitoring and virtual care supported by primary care for people living with chronic disease in low socioeconomic neighbourhoods on ambulance ramping, readmission and GP clinic bloc
Scientific title
safe@home: effectiveness and cost effectiveness of telemonitoring and virtual care supported by primary care for people living with chronic disease in low socioeconomic neighbourhoods on ambulance ramping, readmission and GP clinic bloc
Secondary ID [1] 310540 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure
 331360 0
chronic obstructive pulmonary disease 331361 0
diabetes 331362 0
hypertension 331363 0
Condition category
Condition code
Cardiovascular 328107 328107 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 328108 328108 0 0
Hypertension
Respiratory 328109 328109 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 328110 328110 0 0
Diabetes
Public Health 328492 328492 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After randomisation, the Northern Adelaide Health Network (NALHN) safe@home telehealth nurses will inform intervention group participants that a telemonitoring and self-care kit will be delivered to their home and set-up and initial training will be conducted by video call through the tablet included in the kit which contains easy-to-use monitoring, analysis and communication technology, including a touch-screen tablet with tutorial videos on how to use the telemonitoring system which include various tools for monitoring vital symptoms and signs via blue tooth (pulse oximetry, blood pressure monitor, glucometer, thermometer, scale).
The communication technology has been previously developed and applied for telemonitoring of chronic diseases for people living in rural areas in Australia by the Integrated Cardiovascular Clinical Network (iCCnet SA), a branch of the South Australian Department of Health. The technology can be personalised and has branching and decision support logic to ensure relevance to the patient.Personalisation will occur after baseline data information entered by the patient during the baseline videocall with the nurse. Only questionnaires and education relevant to individual patients will be offered in subsequent assessments. This will make it possible for people to self-monitor and gain immediate test results at the local point of care. The expected duration of the tutorial video is 3 minutes and the complete set-up of the technology 12 minutes.
Participants will be encouraged to complete a self-assessment through the technology at least once a week for 12 months. This has an expected duration of 30 minutes and includes:
o Physical Activity assessed by steps per day, minutes of moderate or vigorous physical activity per day measured by the International Physical Activity Questionnaire (IPAQ) Short Form and the 6-Minute Walking Test.
o Healthy Eating assessed by the Short Food Survey (SFS) Questionnaire
o Medication Adherence measured by the Adherence Scale in Chronic Diseases (ASCD) questionnaire
o Sleep Apnoea measured by the STOP-BANG questionnaire which has questions about snoring history, tiredness during the day, observed stop of breathing while sleeping, blood pressure, body mass index, age, neck circumference and gender.
o Depression measured by the Patient Health Questionnaire (PHQ) 2 and 9
o Anxiety assessed by the Generalized Anxiety Disorder (GAD) 7 Questionnaire
o Health Related Quality of Life measured by the European Quality of Life 5 Dimensions 5 Levels (EQ5D-5L) questionnaire
The NALHN telehealth nurses will review data entry daily. Nurse support will be available from 9 am to 5 pm daily during the trial, with all patients advised to implement emergency management plans out-of-hours if there is a clinical problem. The service will also provide information technology (IT) support. The NALHN safe@home telehealth nurse will contact the participants by video call 1) For any pre-specified clinical data variation; 2) When data has not been entered for >7 days; and 3) Routine follow-up at 30 days, 90 days, and 12 months. The telemonitoring system is intuitive and automatically triages patients using a red flag system. Telemonitoring variances will activate a traffic light system response system. Green - all measurements normal (no action); Amber - data variances, data queries will have 3 levels of response according to need: 1) Call from the Telemonitoring Nurse, 2) Activation of Better Care Nurse home visit or Telehealth call from GP, 3) Activation of a home visit by Locum GP. RED - call Paramedics.
Intervention code [1] 326930 0
Treatment: Devices
Comparator / control treatment
The usual care intervention includes all aspects of current, routine, primary, intermediate or specialist care, as required. It also includes filling questionnaires, home follow-up phone calls at 30 days / 90 days and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 335984 0
Healthcare utilisation composite score comprised of incident rates of readmission, ED presentations and unplanned primary care consult assessed via the Electronic Medical Record (EMR) review by the research nurse with confirmation by a General Medicine registrar.
Timepoint [1] 335984 0
30 days, 90 days, and 12 months post-baseline
Secondary outcome [1] 426363 0
Length of in-hospital stay assessed as the difference in days between the date of hospital readmission and date of discharge/hospital transfer/death. The dates will be retrieved from the EMR by the research nurse.
Timepoint [1] 426363 0
30 days, 90 days, and 12 months post-baseline
Secondary outcome [2] 426364 0
Hyperlipidaemia control as measured by low density lipoprotein (LDL) cholesterol difference between index admission and LDL measurement at the follow-up timepoints. LDL data will be collected from the EMR by the research nurse.
Timepoint [2] 426364 0
30 days, 90 days, and 12 months post-baseline
Secondary outcome [3] 426365 0
Diabetes control as measured by HbA1C difference between index admission and at the follow-up timepoints for patients with diabetes. HbA1C data will be collected from the EMR by the research nurse.
Timepoint [3] 426365 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [4] 426366 0
Heart failure control as measured by brain-type natriuretic peptide (BNP) and weight (kg) difference between index admission and at the follow-up timepoints for patients with heart failure. BNP data will be collected from the EMR by the research nurse.
Timepoint [4] 426366 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [5] 426367 0
Blood pressure control as measured by systolic and diastolic blood pressure <140 mmHg and <90 mmHg at the follow-up timepoints. Blood pressure data will be collected from the EMR by the research nurse.
Timepoint [5] 426367 0
30 days, 90 days and 12 months post-baseline
Secondary outcome [6] 426368 0
Lung function measured by oxymetry saturation at each of the follow-up timepoints. Oximetry data will be collected from the telemonitoring system
Timepoint [6] 426368 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [7] 426369 0
Sleep apnoea as measured by the Snoring history, Tiredness during the day, Observed stop of breathing while sleeping, Blood pressure, Body Mass Index, Age, Neck circumference and Gender (STOP-BANG) questionnaire will be assessed by patient data entry over the telemonitoring tablet (intervention group) or phone interview with nurse (control group)
Timepoint [7] 426369 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [8] 426370 0
Medication adherence as measured by the The Adherence Scale in Chronic Diseases (ASCD) questionnaire assessed by patient data entry over the telemonitoring tablet (intervention group) or phone interview with nurse (control group).
Timepoint [8] 426370 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [9] 426374 0
Healthy Eating as measured by the short food survey (SFS) which measures 'usual' intake of seven food groups, three food choice indicators and variety. The questionnaire will be assessed by patient data entry over the telemonitoring tablet (intervention group) or phone interview with nurse (control group).
Timepoint [9] 426374 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [10] 426375 0
Physical Activity as measured by steps per day assessed by patient data entry over the telemonitoring tablet (intervention group) or phone interview with nurse (control group)
Timepoint [10] 426375 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [11] 426376 0
Depression assessed by the Patient Health Questionnaire (PHQ) 2 and 9. These questionnaires will be assessed by patient data entry over the telemonitoring tablet (intervention group) or phone interview with nurse (control group).
Timepoint [11] 426376 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [12] 426377 0
Patient-reported experience measures (PREMS) will be assessed via the NALHN’s consumer satisfaction questionnaire which is a questionnaire with close and open-ended satisfaction questions currently used by NALHN to evaluate usual care that will be adapted to include telemonitoring questions for the intervention group. The questionnaire will be mailed by participants in the control group and delivered via the telemonitoring platform for the intervention group.
Timepoint [12] 426377 0
12 months post-baseline
Secondary outcome [13] 426378 0
Engagement with the telemonitoring system will be assessed via analytics of the number of data entries in the telemonitoring platform by the patient.
Timepoint [13] 426378 0
90 days and 12 months post-baseline
Secondary outcome [14] 426379 0
Quality and reliability of telemonitoring data will be assessed via quality assurance reports generated by the platform. The same data will be extracted from the patients assigned to usual care from EMR and questionnaires filled.
Timepoint [14] 426379 0
Monthly up to 12 months post-baseline
Secondary outcome [15] 426388 0
Cost-effectiveness to the health system through incremental cost per unit change in the composite score of health care utilisation; and cost-utility through the incremental costs per quality-adjusted life-year (QALY) gained.
Timepoint [15] 426388 0
12 months post-baseline
Secondary outcome [16] 426389 0
Affordability to the Australian healthcare budget through a Budget Impact Analysis (BIA)
Timepoint [16] 426389 0
12 months post-baseline
Secondary outcome [17] 427882 0
Physical Activity as measured by minutes of moderate and vigorous activity per day assessed by the International Physical Activity Questionnaire (IPAQ) Short Form and entred by patients over the telemonitoring tablet (intervention group) or phone interview with nurse (control group)
Timepoint [17] 427882 0
30 days, 90 days and 12 months post-baseline
Secondary outcome [18] 427883 0
Physical Activity as measured by the 6 Minute Walk Test assessed by patient data entry over the telemonitoring tablet (intervention group) or phone interview with nurse (control group)
Timepoint [18] 427883 0
30 days, 90 days and 12 months post-baseline
Secondary outcome [19] 427884 0
Anxiety measured by the Generalized Anxiety Disorder (GAD) 7 questionnaire. This questionnaire will be assessed by patient data entry over the telemonitoring tablet (intervention group) or phone interview with nurse (control group).
Timepoint [19] 427884 0
30 days, 90 days, 12 months post-baseline
Secondary outcome [20] 427885 0
Health-Related Quality of Life measured by the European Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L). This questionnaire will be assessed by patient data entry over the telemonitoring tablet (intervention group) or phone interview with nurse (control group).
Timepoint [20] 427885 0
30 days, 90 days, 12 months post-baseline

Eligibility
Key inclusion criteria
• Adults 18 years and over
• Participants who have one or more chronic diseases. These include diabetes, COPD, heart failure and hypertension and at least one admission to hospital in the previous 12 months.
• Ability to use technology, i.e., smartphone (can be supported by a carer)
• Able to provide informed consent.
• For patients where English is their secondary language, an accredited interpreter will be involved.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to give informed consent due to cognitive impairment and no carer to support.
• Unwilling to give informed consent.
• Lives in known poor Wi-Fi neighbourhood.

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)
The nurses recruiting the patients will not have access to the randomisation code until the patient has provided consent for the trial and after all baseline measurements have been completed. Allocation concealment will be enabled by a central randomisation service by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated by computer via block-stratified randomisation in blocks of 10 according to diagnosis to ensure a similar proportion of each condition of interest (diabetes, heart failure, COPD and hypertension) in each arm of the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
Date of last participant enrolment
Anticipated
7/01/2025
Actual
Date of last data collection
Anticipated
7/01/2026
Actual
Sample size
Target
744
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25496 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 41307 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 314742 0
Government body
Name [1] 314742 0
National Health and Medical Research Council
Country [1] 314742 0
Australia
Funding source category [2] 314747 0
Hospital
Name [2] 314747 0
Lyell McEwin Hospital
Country [2] 314747 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford ParkSouth Australia 5042
Country
Australia
Secondary sponsor category [1] 316728 0
Individual
Name [1] 316728 0
Robyn Clark
Address [1] 316728 0
Flinders University, Sturt Rd, Bedford Park, South Australia 5042
Country [1] 316728 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313752 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 313752 0
Ethics committee country [1] 313752 0
Australia
Date submitted for ethics approval [1] 313752 0
11/05/2023
Approval date [1] 313752 0
30/08/2023
Ethics approval number [1] 313752 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129242 0
Prof Robyn Clark
Address 129242 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 129242 0
Australia
Phone 129242 0
+61 8 82012366
Fax 129242 0
Email 129242 0
[email protected]
Contact person for public queries
Name 129243 0
Robyn Clark
Address 129243 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 129243 0
Australia
Phone 129243 0
+61 8 82012366
Fax 129243 0
Email 129243 0
[email protected]
Contact person for scientific queries
Name 129244 0
Robyn Clark
Address 129244 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 129244 0
Australia
Phone 129244 0
+61 8 82012366
Fax 129244 0
Email 129244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The deidentified individual clinical and outcomes data could possibly be shared with the World Telehealth Initiative for research purposes.
When will data be available (start and end dates)?
Data will be available for 5 years from end of the study (June 2026-June 2031)
Available to whom?
It may be available to the World Telehealth Initiative
Available for what types of analyses?
Effectiveness, cost-effectivenesss, registries, meta-analyses
How or where can data be obtained?
Through request to the principal investigator through email [email protected]


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.