Optimizing Care of Patients Via Telehealth In Monitoring and Augmenting Their Control of Diabetes Mellitus (OPTIMUM)

  • STATUS
    Recruiting
  • days left to enroll
    6
  • participants needed
    330
  • sponsor
    SingHealth Polyclinics
Updated on 1 March 2022
diabetes mellitus
chronic disease
type 2 diabetes mellitus
nephropathy
hemoglobin a1c
glycosylated hemoglobin
retinopathy
diabetic retinopathy
Accepts healthy volunteers

Summary

OPTIMUM study aims to use the telehealth-enabled chronic disease management programme for individuals with chronic diseases to provide timely intervention to prevent disease deterioration, increase compliance to treatment regimen (e.g. medication), and most importantly, engage participants to better manage their own care.

Description

Over 400,000 Singaporeans are living with diabetes, with PM Lee Hsien Loong calling it a "health crisis" and the Ministry of Health declaring a "War on Diabetes" in 2016. One in three Singaporeans has a lifetime risk of getting diabetes and the number of those with diabetes is projected to reach one million by 2050, if current trends continue. Life years lost due to mortality and ill-health related to diabetes was the 4th largest among all diseases in 2010 while the cost burden from diabetes, including medical expenses and productivity loss, was expected to rise from beyond $940 million in 2014 to $1.8 billion in 2050. In addition, every year in Singapore, 2 in 3 new kidney failure cases are due to diabetes, and 1 in 2 people who suffer from a heart attack had co-existing diabetes. Tele-health projects have been conducted successfully overseas on patients suffering from diabetes.

Telehealth refers to the systematic provision of healthcare services over physically separate environments via Information and Communications Technology (ICT) and distinguishes between four main dimensions/ domains of Telemedicine as follow:

  1. Tele-collaboration, which refers to interactions between (facility-based or mobile) onsite and remote healthcare professionals for clinical purposes e.g. referral, co-diagnosis, supervision or case review. The distinguishing feature is that healthcare professionals are involved at both ends of the interaction and a patient may or may not be involved in the same Telemedicine interaction.
  2. Tele-treatment, which refers to interactions between remote healthcare professionals and patients/ caregivers for the purposes of direct clinical care. The distinguishing feature is that a patient or caregiver is involved directly at one end of the interaction and this creates (or presupposes the existence of) a professional-patient relationship. Tele-treatment is used in the remote delivery of primary care and many forms of speciality care.
  3. Tele-monitoring, which refers to biomedical and other forms of data collection directly from patients (or through caregivers) by remote systems, which are used by healthcare professionals for clinical purposes such as vital signs monitoring and home nursing. Tele-monitoring is used in remote chronic disease management. The distinguishing feature is that a healthcare professional or organisation is engaged at one end. Another feature of Tele-monitoring is that it need not create (or presuppose the existence of) a professional-patient relationship even though the healthcare organisation as a whole might ow a duty of care to the patient.
  4. Tele-support, which refers to the use of online services for non-clinical (ie educational and administrative) purposes to support the patient, and caregiver. The "More Independent" programme run by Philips and the Liverpool Clinical Commissioning Group (CCG) provided telehealth services for 1,808 patients recruited from the primary care setting in Liverpool. The study showed reductions in emergency admissions and secondary care costs (in comparison with the control group) ranging from 22% to 32% for patients with above average risk (25% or more). Patient reported outcomes (PRO) also show that 90% of patients feel more in control, have gained confidence and/or feel better able to cope with their condition.

However, there has been no such large scale study done in Singapore to study the impact of telehealth on the disease progression, healthcare utilisation and cost of care for diabetic patients in the primary care setting. As such, an evaluation of a prospective telehealth programme, i.e. Optimizing care of Patients via Telehealth In Monitoring and Augmenting their control of Diabetes Mellitus (OPTIMUM) is being planned for in SingHealth Polyclinics.

The current standard of care comprises on-site measurements of clinical parameters and education in a usual outpatient clinic setting. The telehealth programme comprises remote patient monitoring, education, individualised on-line health coaching and timely interventions provided by primary healthcare professionals in polyclinics. The proposed Philips VitalHealth solution incorporates telehealth-enabled chronic disease management and care coordination. The telehealth-enabled chronic disease management programme is customised for individuals with chronic diseases and aims to provide timely intervention to prevent disease deterioration, increase compliance to treatment regimen (e.g. medication), and most importantly, engage participants to better manage their own care.

On the insurance front, there are many "gaps" present in the insurance industry today with regard to chronic diseases, and to this end, Reinsurance Group of America (RGA) is interested to jointly study the effectiveness of a telehealth programme on diabetic patients, so that they can develop new health insurance products that can meet that insurance gap.

Details
Condition Diabetes Mellitus
Treatment OPTIMUM programme
Clinical Study IdentifierNCT04306770
SponsorSingHealth Polyclinics
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Singapore Citizen or Permanent Resident
\. Age 26 - 65 years (latest age of entry for insurance coverage is 65 at
next birthday)
\. Type 2 Diabetes Mellitus (HbA1c 10% and 7.5% per latest reading) with and
without the following complications
Mild non-proliferative diabetic retinopathy without any macular or retinal involvement
Chronic Kidney Diseases up to stage 3
Patients registered with participating polyclinic
Non-smoker, or ex-smoker who has completely quit smoking for at least 12 months
Existing user of smartphone and is willing to download the relevant mobile application (iPhone or Android phones are acceptable)
Expressed willingness to use the telehealth system and devices according to study protocol during the study period

Exclusion Criteria

Poorly controlled glycemic control with HbA1c > 10% (latest reading)
Cognitively impaired based on diagnosis of dementia or mild cognitive impairment (MCI) in the electronic health records (EHR)
Existing conditions listed below, as documented in the EHR
Any proliferative diabetic retinopathy (moderate to severe) and any macular or other retinal complications
Chronic kidney disease Stage 4 or 5
Coronary arterial diseases
Cerebrovascular diseases such as transient ischemic attach (TIA) or stroke
Peripheral vascular disease (result from diabetic foot screening)
Known cognitive impairment, including MCI
Not able to use smartphone despite coaching
Any end-stage disease with life prognosis of < 2 year
Patients who are not willing or are not able to commit to the entire Optimum program
Pregnant women
Currently enrolled in another study / programme involving a novel therapeutic drug or device
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note