Optimizing Care of Patients Via Telehealth In Monitoring and Augmenting Their Control of Diabetes Mellitus
OPTIMUM
1 other identifier
interventional
330
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Jan 2020
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2020
CompletedFirst Submitted
Initial submission to the registry
March 6, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMarch 13, 2020
March 1, 2020
2.4 years
March 6, 2020
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Diabetic control
HbA1c (in percentage)
6 months
Secondary Outcomes (11)
Diabetic control
12 months, 24 months
Blood pressure control
6 months, 12 months, 24 months
Optimal weight control
6 months, 12 months, 24 months
Utility Score
6 months, 12 months, 24 months
Diabetic medication adherence 9 Diabetic medication adherence (Oral Hypoglycemia agent)
6 months, 12 months, 24 months
- +6 more secondary outcomes
Study Arms (2)
Intervention
ACTIVE COMPARATOROPTIMUM Programme
Control
NO INTERVENTIONTreatment as usual
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SingHealth Polyclinicslead
- MOH Office for Healthcare Transformation (MOHT), Singaporecollaborator
- Phillips Healthcare, Singaporecollaborator
- Reinsurance Group of America (RGA), Singaporecollaborator
Study Sites (1)
Sengkang Polyclinic
Singapore, 545025, Singapore
Related Publications (3)
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.
BACKGROUNDTan 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.
PMID: 39719282DERIVEDGoh 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.
PMID: 33902656DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ngiap Chuan Tan, FCFPS
SingHealth Polyclinics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2020
First Posted
March 13, 2020
Study Start
January 20, 2020
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
March 13, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share