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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

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.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000396325
Acronym
PHCPCPS
Enrollment
171
Registered
2017-03-17
Start date
2013-12-17
Completion date
2014-07-07
Last updated
2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The proof of concept pilot explores the effectiveness of Remote Patient Monitoring (RPM) to support patients with COPD and Diabetes. The IT system used in this pilot project is a web based platform that can be accessed from any internet connected device. The patient, when accessing the platform, will be directed to their personalised care plan that has a questionnaire designed to educate and guide the client to monitor and support their own health. The peripheral devices that link to the system, enable the monitoring of clinical signs and symptoms such as SaO2, blood pressure and blood glucose measures. For the health service clinicians accessing the platform, the RPM system identifies in real time which clients have recorded results at that point in time and which have not, it provides an indication of which results are at variance to the result parameters set for each individual;, thus enabling a rapid and timely response. The RPM system generates individualized reporting that allows the clinicians to monitor trends within a client’s health care over time, enabling treatment to be appropriately adapted as and if required. The pilot was supported by a Data Safety Monitoring Board and is aim at evaluating the effectiveness of the tele-health intervention

Interventions

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 speci

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.

Sponsors

Barwon Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026