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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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3 April 2017 |
Main ID: |
ACTRN12617000396325 |
Date of registration:
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17/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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. |
Date of first enrolment:
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17/12/2013 |
Target sample size:
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400 |
Recruitment status: |
Stopped early |
URL:
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http://www.anzctr.org.au/ACTRN12617000396325.aspx |
Study type:
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Interventional |
Study design:
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Randomised controlled trial
Parallel |
Phase:
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Not Applicable
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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Diabetes
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Chronic Obstructive Airways Disease
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Intervention(s)
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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
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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