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Diabetes MellitusOPTIMUMNCT04306770

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

A study testing OPTIMUM programme in people with Diabetes Mellitus, run by SingHealth Polyclinics at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 26 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
OPTIMUM programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteSingapore
Study dates
20 Jan 2020to 1 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 26 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1 . Singapore Citizen or Permanent Resident
  • 2. Age 26 - 65 years (latest age of entry for insurance coverage is 65 at next birthday)
  • 3. 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
  • 4. Patients registered with participating polyclinic
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  • 5. Non-smoker, or ex-smoker who has completely quit smoking for at least 12 months
  • 6. Existing user of smartphone and is willing to download the relevant mobile application (iPhone or Android phones are acceptable)
  • 7. Expressed willingness to use the telehealth system and devices according to study protocol during the study period

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site, 1 recruiting
  • Sengkang Polyclinic

    Singapore, 545025

    Cia Sin Lee, FCFPS, +65-63507363, lee.cia.sin@singhealth.com.sg

    Recruiting

Other trials in Singapore

About this study

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.

Read the detailed 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.

Being tested
OPTIMUM programme
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPTIMUM programmeOther

    OPTIMUM programme encompass of telehealth service to support the patient. Study participants will be given devices (Bluetooth-enabled blood pressure machine, weighing scale and glucometer) to monitor their parameters at home. Care team will use the Phillips "Vital Health" to perform tele-monitoring, tele-management (individualized on-line health coaching and timely interventions), and to deliver education content.

Study groups in NCT04306770
Study groupRoleWhat they receive
InterventionActive comparatorOPTIMUM Programme
Receives: Other: OPTIMUM programme
ControlNo interventionTreatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetic control

    HbA1c (in percentage)

    Measured: 6 months

Secondary outcomes (11)
  1. Diabetic control

    HbA1c (in percentage)

    Measured: 12 months, 24 months

  2. Blood pressure control

    Systolic and diastolic blood pressure (in mmHg)

    Measured: 6 months, 12 months, 24 months

  3. Optimal weight control

    Weight (in kilogram)

    Measured: 6 months, 12 months, 24 months

  4. Utility Score

    EQ-5D-5L questionnaire, reported as index value by applying the formula. the higher the score the better.

    • EQ-5D-5L is not an abbreviation

    Measured: 6 months, 12 months, 24 months

  5. Diabetic medication adherence 9 Diabetic medication adherence (Oral Hypoglycemia agent)

    Medication Adherence Rating Scale 5 (MARS 5) - max score of 25, min score of 5 (the higher the score the better the adherence)

    Measured: 6 months, 12 months, 24 months

  6. Diabetic medication adherence (Insulin)

    Medication possession ratio (MPR) - max score of 1, min score of 0, higher number indicate better adherence

    Measured: 6 months, 12 months, 24 months

  7. Diabetic knowledge

    23 items Michigan Diabetes Research and Training Center's revised Diabetes Knowledge Test - Max Score of 23, Min score of 0, the higher the score the better the knowledge

    Measured: 6 months, 12 months, 24 months

  8. Diabetic self-care

    Self-Care Inventory-Revised Version (SCI-R) scale- Max sore of 15, min score of 15 - the higher the score the better the self-care

    Measured: 6 months, 12 months, 24 months

  9. Diabetes distress survey

    Problem Areas in Diabetes Scale (PAID), Max score of 80, min score of 0, the lower the core the better (lesser distress)

    Measured: 6 months, 12 months, 24 months

  10. Healthcare utilization

    Healthcare cost

    Measured: 6 months, 12 months, 24 months

  11. Incidence of vascular complications

    Incidence of both micro- and macro- vascular complication

    Measured: 6 months, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start20 Jan 2020
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04306770
Sponsor's protocol ID
2019/2340
Acronym
OPTIMUM
Status last verified
Mar 2020
First submitted
6 Mar 2020
Last updated
13 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Berkel C van, Smith M, Horsfield D, McManus H. Evidence for Supported Self-Care at Scale. International Journal of Integrated Care. 2016 Nov 9;16(5):S44.

  • Tan NC, Gong PP, Lee CS, Goh SKL, Ang SB, Koh GCH. Theory-based behaviour modification of Asian adults with type-2 diabetes mellitus after participating in a novel telemonitoring system: a qualitative research study. BMJ Open. 2024 Dec 23;14(12):e080830. doi: 10.1136/bmjopen-2023-080830.

    PubMed 39719282
  • Goh KLS, Lee CS, Koh CHG, Ling NL, Ang SB, Oh C, Lin Y, Yuan W, Zheng QC, Tan NC. Evaluating the effectiveness and utility of a novel culturally-adapted telemonitoring system in improving the glycaemic control of Asians with type-2 diabetes mellitus: a mixed method study protocol. Trials. 2021 Apr 26;22(1):305. doi: 10.1186/s13063-021-05240-6.

    PubMed 33902656

Questions about this trial

What is this clinical trial studying?

A study testing OPTIMUM programme in people with Diabetes Mellitus, run by SingHealth Polyclinics at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cia Sin Lee, FCFPS (+65 6350 7363, lee.cia.sin@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetic control (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04306770, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.

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