Intervention for Diabetes With Education, Advancement and Support

NCT02466880 | Completed

• 1 other identifier: IDEAS001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate a culturally appropriate, low cost and sustainable management plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote improvements in diet, increased physical activity and weight loss. Translation of lifestyle intervention to real-life settings however remains a major challenge. The investigators therefore propose a diabetes management trial for T2DM patients using telemedicine. This project's innovations include the use of information technology to deliver messages to the physicians while similarly involving family members of diabetics to manage the patient's condition collectively. This creates a sense of well-being, empowering the individual as well as the community to be responsible for their own health and well-being

Conditions

Diabetes Mellitus

Keywords

Type 2; NIDDM

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

  3 months, 6 months, 12 months

Secondary Outcomes (5)

• Change in Quality of life - Measured with EQ5D

  3 months, 6 months, 12 months

• Change in Blood pressure

  3 months, 6 months, 12 months

• Change in Weight

  3 months, 6 months, 12 months

• Cost effectiveness and cost utility

  1 year

• Change in Cholesterol

  3 months, 6 months, 12 months

Study Arms (2)

Telemedicine

EXPERIMENTAL

Diabetes education and support via telemedicine

Device: Telemedicine

Usual care

ACTIVE COMPARATOR

Diabetes education and support in person

Other: Usual care

Interventions

Telemedicine DEVICE

A diabetes self-management and education program delivered via telemedicine

Telemedicine

Usual care OTHER

A 15-30 minute diabetes self-management session. Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.

Usual care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes diagnosed by a physician at least six months prior to study enrollment
• HbA1c of \> 7.5% but less than 11.0% within the most recent 3 months
• Access to internet and an e-mail address , or access to a smartphone with 3G services
• Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any other conditions that can impede participation

You may not qualify if:

• Unable or unwilling to give informed consent or communicate with local study staff
• Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
• Hospitalization for depression in past six months
• Plans to relocate to an area or travel plans that do not permit full participation in the study
• Lack of support from primary health care provider or family members
• History of bariatric surgery, small bowel resection, or extensive bowel resection
• Currently pregnant or nursing
• Cancer: requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
• Cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Sponsors & Collaborators

• Monash University: lead
• MOSTI Malaysia: collaborator

Study Sites (1)

Klinik Kesihatan Pandamaran

Klang, Selangor, 42000, Malaysia

Location

Related Publications (3)

• Lee JY, Chan CKY, Chua SS, Paraidathathu T, Lee KK, Tan CSS, Nasir N, Lee SWH. Using telemedicine to support care for people with type 2 diabetes mellitus: a qualitative analysis of patients' perspectives. BMJ Open. 2019 Oct 22;9(10):e026575. doi: 10.1136/bmjopen-2018-026575.

  PMID: 31640990 DERIVED

• Lee JY, Chan CKY, Chua SS, Ng CJ, Paraidathathu T, Lee KKC, Lee SWH. Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):87-94. doi: 10.1007/s11606-019-05316-9. Epub 2019 Sep 11.

  PMID: 31512187 DERIVED

• Lee JY, Chan CK, Chua SS, Ng CJ, Paraidathathu T, Lee KK, Lee SW. Intervention for Diabetes with Education, Advancement and Support (IDEAS) study: protocol for a cluster randomised controlled trial. BMC Health Serv Res. 2016 Sep 29;16(1):524. doi: 10.1186/s12913-016-1782-y.

  PMID: 27683021 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 9, 2015
• Study Start: April 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

MY (1)