Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000396325
Ethics application status
Approved
Date submitted
22/02/2017
Date registered
17/03/2017
Date last updated
17/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Personalised Health Care Proof of Concept Pilot to test the intervention of home health monitoring in supporting the self management needs of participants with Chronic Obstructive Pulmonary Disease (COPD) and Diabetes
Scientific title
Personalised Health Care- efficacy of home health monitoring intervention in supporting the self management needs of participants with COPD and Diabetes: proof of concept study.
Secondary ID [1] 291422 0
NIL
Universal Trial Number (UTN)
Trial acronym
PHCPCPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Airways Disease 302178 0
Diabetes 302179 0
Condition category
Condition code
Respiratory 301788 301788 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 301789 301789 0 0
Diabetes
Public Health 302005 302005 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an additional monitoring service on top of patients "usual care".
There are three core aspects to the intervention
*patients submitting data on a daily basis
* Clinical staff to provide support for patients to self-manage accessible seven days a week twenty four hours a day
* Individualised care plans
Participants are requested to enter their bio metric data on a daily basis for the duration of the trial. Participants are also requested to answer a series of questions specifically designed to support the development of their health literacy about their condition (COPD and or Diabetes).
Daily nurse monitored tele-health is facilitated by a fit for purpose IT system was purchased to facilitate the pilot. The name of the IT system is Remote Patient Monitoring (RPM) from a Canadian telco Telus. The IT platform allows for the data that is submitted by patients to be sorted by the system and only data that is outside of usual for that particular patient is flagged for follow up by the nurses. The communication between the patient and nurse is then facilitated by video conferencing using the systems supplied to participants. The nurse or patient can instigate a phone call. The communication supports the immediate needs of the patient, for example the need to address a low blood sugar. The less immediate needs are also supported in planning for better management of chronic disease eg. early presentation to General practitioners based on early symptom identification. These phone/Video Conferencing sessions can take anywhere from 2minutes to 20 minutes depending on the need of the patient.
Personalized care plans are developed. The care plans are designed in collaboration with the patient by the nurse on admission and altered as required during the intervention with the patient depending on their personal (SMART) goals. The individualised plans are achieved in three ways
* By selecting “protocols” which are designed by Barwon Health and instigate the questions asked of and the information delivered to patients within the IT system. The question sets are designed to enhance health literacy and provide support for early identification of symptoms and in some cases simplified management of these symptoms. For example a foot care protocol for diabetics is available but not necessary for those patients with only COPD. There are approximately 20 protocols to select from. Some of the protocols include hemodynamic measurements, BP, pulse, blood oxygen, Blood sugar levels, temperature, COPD symptom protocols, quit smoking protocols, Keytone protocols, anxiety and depression screening protocols, Medication protocols, pedometer protocols.
* Parameters for the data entered can be altered for patients depending on what is normal for them. For example a patient with COPD might have a usual oxycimitery measurement of 88% and this can be modified from the usual measure in the system of 94%. The other variables that can be altered are Blood Pressure, pulse, weight, blood sugar readings, temperature. All modifications to hemodynamic parameters are agreed to and signed off by senior consultants supporting the program, an Endocrinologist and Respiratory specialist.
* On a fortnightly basis the patients are requested to schedule a meeting time with the nurse to undertake a “Health Coaching” session. These sessions are individualised to what the patient goals are and what is the broader picture for the patient during the preceding two weeks and following two weeks. Issues such as moderately high blood pressure results on a number of occasions would be discussed and if the patient might consider review with their GP. Other issues discussed might be medication changes or health appointments they have or are going to attend. Anxiety and Depression screening also takes place at this session. The sessions can take typically 20-30 minutes depending on the need of the patient and are the main point of review of the care plan.

Patients have access to personalised advice from nurse team 24 hours a day which was provided by a team of nurses with access to specialist if required. Patients have the ability to contact the nurse at any time via phone and via video conferencing 7 days a week 0830 hrs to 1700hrs . If a patient entered their data afterhours and it is outside of their usual parameters an sms message is sent to the on call phone and the nurse is able to review the data and respond to the patient if this is required. Patients are advised and reminded throughout the pilot study period that at any time they feel they require emergency care they should follow their usual practice (eg. call 000).
Research suggests that these aspects individually can improve the consumer's understanding and ability to manage their own health conditions. This proof of concept pilot aims to demonstrate that a combination of these core aspects leads to decreased hospital utilization as well as increases in health literacy and improved ability to self-manage their health conditions. Patients will be enrolled in the pilot for a period of 12 months unless they chose to withdraw and each intervention will be delivered concurrently. The fidelity of the intervention will not be assessed due to the difficult nature of data extraction from the IT system utilised.
Intervention code [1] 297254 0
Rehabilitation
Intervention code [2] 297457 0
Treatment: Other
Comparator / control treatment
The control group consists of consecutively randomized participants who will not received the intervention. The control group will receive usual care inclusive of access to all Community Health and Rehabilitation based programs, All inpatient facilities including emergency acute and sub acute care.
Control group
Active

Outcomes
Primary outcome [1] 301189 0
Mean number of Hospital admissions during the patients 12 month enrollment
Timepoint [1] 301189 0
for the 12 months of the participants enrollment utilising self-reported admissions to private hospital setting and Victorian Admitted Data from Barwon Health data submitted to the Department of Health
Primary outcome [2] 301190 0
mean length of stay for patients for that might be admitted during their 12 month enrollment.
Timepoint [2] 301190 0
for the 12 months of the participants enrollment utilising self-reported admissions to private hospital setting and Victorian Admitted Data from Barwon Health data submitted to the Department of Health
Primary outcome [3] 301192 0
Proportion of participants with changes to their Quality of Life survey using the Assessment of Quality of Life (AQoL-8D) instrument
Timepoint [3] 301192 0
Base line and at 12 months
Secondary outcome [1] 331982 0
Proportion of participants with changes to their Health literacy scores using the Health Education Impact Questionnaire (heiQ)
Timepoint [1] 331982 0
Base line and at 12 months
Secondary outcome [2] 331983 0
proportion of the participants that have a change to the measurement of their 6 min walk test (COPD)
Timepoint [2] 331983 0
base line and 12 months
Secondary outcome [3] 331984 0
Proportion of participants with a reduction in resting blood pressure, assessed using a digital sphygmomanometer
Timepoint [3] 331984 0
base line and 12 months
Secondary outcome [4] 331985 0
proportion of participants with changes in their HbA1C (diabetes)
Timepoint [4] 331985 0
base line and 12 months
Secondary outcome [5] 331986 0
proportion of participants with reduction in serum lipids
Timepoint [5] 331986 0
base line and 12 months
Secondary outcome [6] 331987 0
Proportion of participants with changes to the measurements of depression PHQ 9
Timepoint [6] 331987 0
Base line and 12 months
Secondary outcome [7] 331988 0
Economic evaluation , comparison of cost for service delivery based on admitted data and hospital level costings and self reported data of private hospital admissions and standardized costing for hospital coding. The mean total cost per patient for the intervention group was compared to the mean total cost of the control group. The evaluation included actual nursing resource costing including on call amounts. Purchase of equipment and travel requirements for nursing staff and patients. The Quality of Life using the AQoL-8D ICER is also calculated and contrbutes to the overall evaluation in $ terms
Timepoint [7] 331988 0
for the 12 months of the participants enrollment utilising self-reported admissions to private hospital setting and Victorian Admitted Data from Barwon Health data submitted to the Department of Health and the AQoL- 8D at base line and 12 months
Secondary outcome [8] 331989 0
proportion of participants who present and frequency of their attendance to the Emergency Department during their 12 month enrollment. this was measured using internal the Barwon Health reporting . No private hospital emergency data was provided as there were no private hospital with Emergency Departments at the time of the trial. A report was run daily and at the end of the pilot.
Timepoint [8] 331989 0
for the 12 months of the participants enrollment
Secondary outcome [9] 332629 0
Proportion of participants with changes to the measurements of anxiety GAD 7
Timepoint [9] 332629 0
base line and 12 months

Eligibility
Key inclusion criteria
Barwon Health has formed a partnership with Deakin University's Centre for Pattern Recognition and Data Analytic s (PRaDA) PRaDA Using computer modelling aims to explore latent patterns in health data and medical records and assign individual to their patterns. The method uses characteristics of individual s such as diagnosis , co morbidity , age , gender , admission and length of stay history, diagnosis procedures past HbA1c measures , past operations and past medication to predict the likelihood of numbers of admission between 0 and 1. The patient cohort selected for this trial will have a likelihood of readmission between 0.5 and 0.8 according to PRaDA. and have COPD , Diabetes or both COPD and Diabetes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those living in supported accommodation
Those who do not have a diagnosis of COPD or Diabetes
Those who do not have a PRaDA score of between 0.5 adn 0.8
Those who do not have the ability/dexterity to enter and submit own data via a computer
Those who do not have functional grasp of English
Pregnancy
Vision Impairment or hearing impairment which impacts on ability to use the telehealth device
Poor 12 month prognosis
Severe cognitive impairment as determined by clinical assessment
Sub optimal management of mental illness as per clinical assessment
Current enrollment in Hospital Admission Risk Program (HARP)
Active palliative care patient
Drug or alcohol dependency

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals agreeing to be involved in the study and were assigned by Simple randomisation using a randomisation table created by computer software for three groups
Diabetes
COPD
Both Diabetes and COPD
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
Economic Evaluation was undertaken
Due to the pilot nature of the study, analysis of study data will not follow a hypothesis testing framework. Confidence intervals for efficacy outcomes will be calculated within each group at the 95% confidence level, however no formal significance tests will be made. Hospital admissions will be treated as a binary variable, ED presentations as counts, and LoS as ordinal. Total LoS (summed over all admissions) will be presented.
Allowances for stratification of the sample will be made via the Cochran–Mantel–Haenszel (CMH) test for unadjusted analyses, and adjustment for covariates will further be investigated via logistic regression for binary variables; adjustment for covariates will use Poisson regression for count variables. Analysis of the readmission rates will further be summarised under a time-to-event framework.
Baseline measures will be summarised by group, as will any differences post-intervention. Trial procedures (such as recruitment and retention rates, compliance and monitoring loads) will be monitored and summarised by confidence intervals where appropriate.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
17/12/2013
Date of last participant enrolment
Anticipated
Actual
7/07/2014
Date of last data collection
Anticipated
Actual
7/07/2015
Sample size
Target
400
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7542 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 15366 0
3220 - Geelong
Recruitment postcode(s) [2] 15367 0
3215 - Rippleside
Recruitment postcode(s) [3] 15368 0
3215 - Bell Park
Recruitment postcode(s) [4] 15369 0
3215 - Drumcondra
Recruitment postcode(s) [5] 15370 0
3215 - Hamlyn Heights
Recruitment postcode(s) [6] 15371 0
3215 - Geelong North
Recruitment postcode(s) [7] 15372 0
3215 - Bell Post Hill
Recruitment postcode(s) [8] 15373 0
3215 - North Geelong
Recruitment postcode(s) [9] 15374 0
3216 - Belmont
Recruitment postcode(s) [10] 15375 0
3216 - Freshwater Creek
Recruitment postcode(s) [11] 15376 0
3216 - Grovedale
Recruitment postcode(s) [12] 15377 0
3216 - Grovedale East
Recruitment postcode(s) [13] 15378 0
3216 - Highton
Recruitment postcode(s) [14] 15379 0
3216 - Marshall
Recruitment postcode(s) [15] 15380 0
3216 - Mount Duneed
Recruitment postcode(s) [16] 15381 0
3216 - Wandana Heights
Recruitment postcode(s) [17] 15382 0
3216 - Waurn Ponds
Recruitment postcode(s) [18] 15383 0
3218 - Fyansford
Recruitment postcode(s) [19] 15384 0
3218 - Geelong West
Recruitment postcode(s) [20] 15385 0
3218 - Herne Hill
Recruitment postcode(s) [21] 15386 0
3218 - Manifold Heights
Recruitment postcode(s) [22] 15387 0
3218 - Murgheboluc
Recruitment postcode(s) [23] 15388 0
3219 - Breakwater
Recruitment postcode(s) [24] 15389 0
3219 - East Geelong
Recruitment postcode(s) [25] 15390 0
3219 - Newcomb
Recruitment postcode(s) [26] 15391 0
3219 - St Albans Park
Recruitment postcode(s) [27] 15392 0
3219 - Thomson
Recruitment postcode(s) [28] 15393 0
3219 - Whittington
Recruitment postcode(s) [29] 15394 0
3220 - Bareena
Recruitment postcode(s) [30] 15395 0
3220 - Newtown
Recruitment postcode(s) [31] 15396 0
3220 - South Geelong
Recruitment postcode(s) [32] 15397 0
3222 - Clifton Springs
Recruitment postcode(s) [33] 15398 0
3222 - Curlewis
Recruitment postcode(s) [34] 15399 0
3222 - Drysdale
Recruitment postcode(s) [35] 15400 0
3222 - Mannerim
Recruitment postcode(s) [36] 15401 0
3222 - Marcus Hill
Recruitment postcode(s) [37] 15402 0
3222 - Wallington
Recruitment postcode(s) [38] 15403 0
3223 - Bellarine
Recruitment postcode(s) [39] 15404 0
3223 - Indented Head
Recruitment postcode(s) [40] 15405 0
3223 - Portarlington
Recruitment postcode(s) [41] 15406 0
3223 - St Leonards
Recruitment postcode(s) [42] 15407 0
3224 - Leopold
Recruitment postcode(s) [43] 15408 0
3224 - Moolap
Recruitment postcode(s) [44] 15409 0
3225 - Point Lonsdale
Recruitment postcode(s) [45] 15410 0
3225 - Queenscliff
Recruitment postcode(s) [46] 15411 0
3225 - Swan Bay
Recruitment postcode(s) [47] 15412 0
3225 - Swan Island
Recruitment postcode(s) [48] 15413 0
3226 - Ocean Grove
Recruitment postcode(s) [49] 15414 0
3227 - Barwon Heads
Recruitment postcode(s) [50] 15415 0
3227 - Breamlea
Recruitment postcode(s) [51] 15416 0
3227 - Connewarre
Recruitment postcode(s) [52] 15417 0
3228 - Bellbrae
Recruitment postcode(s) [53] 15418 0
3228 - Torquay
Recruitment postcode(s) [54] 15419 0
3330 - Rokewood
Recruitment postcode(s) [55] 15420 0
3321 - Hesse
Recruitment postcode(s) [56] 15421 0
3328 - Teesdale
Recruitment postcode(s) [57] 15422 0
3331 - Bannockburn
Recruitment postcode(s) [58] 15423 0
3331 - Gheringhap
Recruitment postcode(s) [59] 15424 0
3331 - Maude
Recruitment postcode(s) [60] 15425 0
3331 - Steiglitz
Recruitment postcode(s) [61] 15429 0
3332 - Lethbridge
Recruitment postcode(s) [62] 15430 0
3333 - Meredith

Funding & Sponsors
Funding source category [1] 295702 0
Government body
Name [1] 295702 0
Department of Health
Country [1] 295702 0
Australia
Funding source category [2] 295704 0
Hospital
Name [2] 295704 0
Barwon Health
Country [2] 295704 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
156 Bellerine St
Geelong
Victoria
3220
Country
Australia
Secondary sponsor category [1] 294542 0
Government body
Name [1] 294542 0
Department of Health Victoria
Address [1] 294542 0
50 Londsdale St
Melbourne
Victoria
3000
Country [1] 294542 0
Australia
Other collaborator category [1] 279441 0
University
Name [1] 279441 0
Deakin University
Address [1] 279441 0
221 Burwood Highway,
Burwood,
Victoria
3125
Country [1] 279441 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297008 0
Human Research Ethics Committee Barwon Health
Ethics committee address [1] 297008 0
Ethics committee country [1] 297008 0
Australia
Date submitted for ethics approval [1] 297008 0
10/04/2013
Approval date [1] 297008 0
06/12/2013
Ethics approval number [1] 297008 0
13/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1515 1515 0 0
/AnzctrAttachments/372411-13 14 HREC approval.pdf (Ethics approval)
Attachments [2] 1516 1516 0 0
/AnzctrAttachments/372411-HREC PHC origninal.pdf (Protocol)
Attachments [3] 1517 1517 0 0
/AnzctrAttachments/372411-Merge letter with CHARS letterhead 1 12 13 final.pdf (Participant information/consent)

Contacts
Principal investigator
Name 72702 0
Ms Robyn Hayles
Address 72702 0
c/- Barwon Health Corporate Offices
156 Bellerine St
Geelong
Victoria
3220
Country 72702 0
Australia
Phone 72702 0
+61 3 42151057
Fax 72702 0
Email 72702 0
[email protected]
Contact person for public queries
Name 72703 0
Josephine Stevens
Address 72703 0
Barwon Health
120 Settlement Rd
Belmont
Victoria
3216
Country 72703 0
Australia
Phone 72703 0
+61 448688082
Fax 72703 0
Email 72703 0
[email protected]
Contact person for scientific queries
Name 72704 0
Josephine Stevens
Address 72704 0
Barwon Health
120 Settlement Rd
Belmont
Victoria
3216
Country 72704 0
Australia
Phone 72704 0
+61 448688082
Fax 72704 0
Email 72704 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
SourceTitleYear of PublicationDOI
EmbaseCost-effectiveness of personalised telehealth intervention for chronic disease management: A pilot randomised controlled trial.2023https://dx.doi.org/10.1371/journal.pone.0286533
N.B. These documents automatically identified may not have been verified by the study sponsor.