Effects of Multidisciplinary Intensive Targeted Care in Improving Diabetes Outcomes: a Pilot Study in Singapore

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to investigate whether channeling purposefully structured resources to patients at high risk of developing diabetic complications to interdisciplinary team clinic consultations, interspersed with closer remote follow-up and aided by simple technology will be more effective than usual care in controlling diabetes mellitus, controlling multiple cardiovascular risk factors and reducing clinical event rates.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes

NCT05203575

Diabetes

UNKNOWN NA

Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device

NCT04518566

Diabetes Mellitus, Type 2

COMPLETED NA

Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

NCT00320008

Type 2 Diabetes

ACTIVE_NOT_RECRUITING NA

Effectiveness of Integrated Care Combined Nutrition and Lifestyle Counselling in Frail Older Patients With Diabetes

NCT05721599

Frailty Diabetes Lifestyle

RECRUITING NA

Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs

NCT05056376

PreDiabetes Hyperglycemia Glucose, High Blood +8 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The prevalence of diabetes in Singapore is estimated to grow from 400,000 to 670,000 by 2030 and an alarming one million by 2050 with the continuing rise in obesity prevalence. The current system currently has no formal stratification of patients for channelling of structured resources to patients that require more intensive treatment and follow-up (those at higher risk of progressing to having complications from diabetes due to poor glycemic control, or those who have signs of early complications).

We will therefore be researching effective health system delivery strategies to improve achievement of treatment targets (eg. HbA1c, blood pressure, LDL) and reduce vascular complications of diabetes mellitus (retinopathy, proteinuria, end stage renal disease, ischemic heart disease). These include:

* Stratification and channelling purposefully structured resources to patients with poorly controlled diabetes mellitus defined as having an HbA1c \>9% on 2 or more occasions, and patients with diabetic complications (estimated glomerular filtration rate eGFR 30-60ml/min or proteinuria \>0.5g/day or urine microalbumin:creatinine ratio \>300mg/g)
* Training of all doctors/DNEs/dietitians involved in the counselling of patients in the field of motivational interviewing
* Providing easy accessibility to resources to allow patients to self-monitor their capillary blood glucose and blood pressure in between clinic visits - loaning of blood pressure units and glucometers for short (1-2 week) periods regularly
* Providing frequent telephone counselling by DNEs and Renal Pharmacists with regards to titration of medications, in particular ACE-inhibitors or angiotensin-receptor blockers to reach treatment targets
* Utilisation of social media and smart phone/tablet applications for relevant patients to improve and increase patient-healthcare professional interaction with regards to diabetes, provide daily bite-sized education via tablet/smart phone media/social media and improve compliance to exercise targets

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Diabetic Nephropathy Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Care

Patients randomized to the standard care group will receive usual care, which consists of clinic visits 4 monthly for review of BP, HbA1c and other investigations, and titration of medications;counseling with the diabetes nurse educator (DNE), and provision of educational materials on diabetes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intensive

Patient randomized to the intensive group will receive additional counselling and education by the DNE, medical social worker (MSW) on self-care and coping strategies for diabetes, and see the renal pharmacist for more intensive titration of antihypertensive medication between doctor visits. They will also be loaned blood pressure monitors and glucometers with test strips to perform self-monitoring at home in between outpatient visits. Smartphone and online technologies will be utilized to improve remote monitoring, education and self-care.

Group Type EXPERIMENTAL

Intensive

Intervention Type BEHAVIORAL

Patients are provided with a BP machine, glucometer and test strips, and instructed how to use either a written or smartphone logbook, photograph their meals and use smartphone apps to measure daily activity. DNEs will contact patients in between visits to reinforce adherence and self-monitoring.

MSWs will conduct at least 6 face-to-face sessions, at 3 weeks then less frequently, on essential self-care behaviours in people with diabetes: healthy eating; being physically active; monitoring of blood sugar; compliance with medications; problem-solving; healthy coping skills; and risk-reduction behaviour.

Renal pharmacists will see patients at 2-4 week intervals for 3 months after the first clinic visit, and subsequently every 3-6 months. They will review patient's compliance, laboratory results and home BP, educate patient and titrate antihypertensives to meet BP goal. Physician referrals will be made for severe hypertension or hypotension, or intolerable side effects.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intensive

Patients are provided with a BP machine, glucometer and test strips, and instructed how to use either a written or smartphone logbook, photograph their meals and use smartphone apps to measure daily activity. DNEs will contact patients in between visits to reinforce adherence and self-monitoring.

MSWs will conduct at least 6 face-to-face sessions, at 3 weeks then less frequently, on essential self-care behaviours in people with diabetes: healthy eating; being physically active; monitoring of blood sugar; compliance with medications; problem-solving; healthy coping skills; and risk-reduction behaviour.

Renal pharmacists will see patients at 2-4 week intervals for 3 months after the first clinic visit, and subsequently every 3-6 months. They will review patient's compliance, laboratory results and home BP, educate patient and titrate antihypertensives to meet BP goal. Physician referrals will be made for severe hypertension or hypotension, or intolerable side effects.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 diabetic patients aged 21-70 years
* Poorly controlled diabetes with microalbuminuria as defined by the following HbA1C \> 9.0% with eGFR30- 60 ml/min and/or proteinuria \>0.5g/day and/or urine microalbumin:creatinine ratio \>300 mg/g on 2 consecutive measurements 3 months apart

Exclusion Criteria

* Type 1 diabetes defined as a history of ketosis at diagnosis \[acute symptoms with heavy ketonuria (\>3+) or ketoacidosis\] or continuous requirement of insulin within one year of diagnosis.
* Psychiatric conditions on medication
* On weight loss medications or have had bariatric surgery
* Life expectancy less than 12 months due to advanced cancers or other life-threatening conditions

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No