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

Diabetes Mellitus Clinical Trial

— OPTIMUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04306770
• Other study ID #: 2019/2340
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2020
• Source: SingHealth Polyclinics
• Contact: Cia Sin Lee, FCFPS
• Phone: +65 6350 7363
• Email: lee.cia.sin[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Years to 65 Years

Eligibility

Inclusion Criteria:

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:

1. Mild non-proliferative diabetic retinopathy without any macular or retinal involvement;

2. Chronic Kidney Diseases up to stage 3

4. Patients registered with participating polyclinic

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

Exclusion Criteria:

1. Poorly controlled glycemic control with HbA1c > 10% (latest reading)

2. Cognitively impaired based on diagnosis of dementia or mild cognitive impairment (MCI) in the electronic health records (EHR)

3. Existing conditions listed below, as documented in the EHR:

1. Any proliferative diabetic retinopathy (moderate to severe) and any macular or other retinal complications;

2. Chronic kidney disease Stage 4 or 5;

3. Coronary arterial diseases.

4. Cerebrovascular diseases such as transient ischemic attach (TIA) or stroke;

5. Peripheral vascular disease (result from diabetic foot screening);

6. Known cognitive impairment, including MCI

4. Not able to use smartphone despite coaching

5. Any end-stage disease with life prognosis of < 2 year

6. Patients who are not willing or are not able to commit to the entire Optimum program

7. Pregnant women

8. Currently enrolled in another study / programme involving a novel therapeutic drug or device

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• OPTIMUM programme
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.

Locations

Country	Name	City	State
Singapore	Sengkang Polyclinic	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
SingHealth Polyclinics	MOH Office for Healthcare Transformation (MOHT), Singapore, Phillips Healthcare, Singapore, Reinsurance Group of America (RGA), Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetic control	HbA1c (in percentage)	6 months
Secondary	Diabetic control	HbA1c (in percentage)	12 months, 24 months
Secondary	Blood pressure control	Systolic and diastolic blood pressure (in mmHg)	6 months, 12 months, 24 months
Secondary	Optimal weight control	Weight (in kilogram)	6 months, 12 months, 24 months
Secondary	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	6 months, 12 months, 24 months
Secondary	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)	6 months, 12 months, 24 months
Secondary	Diabetic medication adherence (Insulin)	Medication possession ratio (MPR) - max score of 1, min score of 0, higher number indicate better adherence	6 months, 12 months, 24 months
Secondary	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	6 months, 12 months, 24 months
Secondary	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	6 months, 12 months, 24 months
Secondary	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)	6 months, 12 months, 24 months
Secondary	Healthcare utilization	Healthcare cost	6 months, 12 months, 24 months
Secondary	Incidence of vascular complications	Incidence of both micro- and macro- vascular complication	6 months, 12 months, 24 months

External Links

•   National Telemedicine guide
•   News higlight on Singapore goverment initiative in tackling diabetes.
•   Report on the Singapore Burden of Diseases Study 2010
•   Singapore Diabetes Statistics