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

NCT03413215 | Unknown

• 1 other identifier: CGH-IDEALS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathy; Hypertension

Outcome Measures

Primary Outcomes (1)

• Composite primary endpoint

  Composite of Incidence of all diabetes-related endpoints including: 1. cardiovascular events (acute myocardial infarction, revascularisation procedures, heart failure, unstable angina, arrhythmia, stroke, transient ischemic attacks requiring hospital admissions) and related death 2. chronic kidney disease (eGFR\<60 ml/min/1.73m2) or end stage renal disease (dialysis and/or eGFR\<15 ml/min/1.73m2) and related death 3. visual impairment (corrected visual acuity of 20/200 or worse) or eye surgery (cataract removal, retinal surgery and vitrectomy) 4. lower extremity amputation or foot ulcers requiring hospitalizations 5. major infections - pulmonary and non-pulmonary requiring hospitalizations 6. all-site cancers 7. death

  3 years

Secondary Outcomes (1)

• Composite secondary endpoint

  3 years

Study Arms (2)

Standard Care

NO INTERVENTION

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.

Intensive

EXPERIMENTAL

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.

Behavioral: Intensive

Interventions

Intensive 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.

Intensive

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Related Publications (6)

• Phan TP, Alkema L, Tai ES, Tan KH, Yang Q, Lim WY, Teo YY, Cheng CY, Wang X, Wong TY, Chia KS, Cook AR. Forecasting the burden of type 2 diabetes in Singapore using a demographic epidemiological model of Singapore. BMJ Open Diabetes Res Care. 2014 Jun 11;2(1):e000012. doi: 10.1136/bmjdrc-2013-000012. eCollection 2014.

  PMID: 25452860 BACKGROUND

• Shaw RJ, McDuffie JR, Hendrix CC, Edie A, Lindsey-Davis L, Nagi A, Kosinski AS, Williams JW Jr. Effects of nurse-managed protocols in the outpatient management of adults with chronic conditions: a systematic review and meta-analysis. Ann Intern Med. 2014 Jul 15;161(2):113-21. doi: 10.7326/M13-2567.

  PMID: 25023250 BACKGROUND

• Chan JC, Gagliardino JJ, Baik SH, Chantelot JM, Ferreira SR, Hancu N, Ilkova H, Ramachandran A, Aschner P; IDMPS Investigators. Multifaceted determinants for achieving glycemic control: the International Diabetes Management Practice Study (IDMPS). Diabetes Care. 2009 Feb;32(2):227-33. doi: 10.2337/dc08-0435. Epub 2008 Nov 25.

  PMID: 19033410 BACKGROUND

• Gaede P, Oellgaard J, Carstensen B, Rossing P, Lund-Andersen H, Parving HH, Pedersen O. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. Diabetologia. 2016 Nov;59(11):2298-2307. doi: 10.1007/s00125-016-4065-6. Epub 2016 Aug 16.

  PMID: 27531506 BACKGROUND

• Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.

  PMID: 39171639 DERIVED

• Tan E, Khoo J, Gani LU, Malakar RD, Tay TL, Tirukonda PS, Kam JW, Tin AS, Tang TY. Effect of multidisciplinary intensive targeted care in improving diabetes mellitus outcomes: a randomized controlled pilot study - the Integrated Diabetes Education, Awareness and Lifestyle modification in Singapore (IDEALS) Program. Trials. 2019 Sep 2;20(1):549. doi: 10.1186/s13063-019-3601-3.

  PMID: 31477163 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joan Khoo, FRCP

  joan.khoo.j.c@singhealth.com.sg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Cheung

CONTACT

+6568502691; ann.cheung.n.s@singhealth.com.sg

Nur Shameerah Abdul Halim

CONTACT

+6568501902; nur_shameerah@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 29, 2018
• Study Start: March 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)