Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments telemedicine, usual care
Sponsor Monash University
Collaborator MOSTI Malaysia
Start date April 2015
End date December 2016
Trial size 240 participants
Trial identifier NCT02466880, IDEAS001

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Diabetes education and support via telemedicine
telemedicine
A diabetes self-management and education program delivered via telemedicine
(Active Comparator)
Diabetes education and support in person
usual care
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.

Primary Outcomes

Measure
Change in Hemoglobin A1c
time frame: 3 months, 6 months, 12 months

Secondary Outcomes

Measure
Change in Quality of life - Measured with EQ5D
time frame: 3 months, 6 months, 12 months
Change in Blood pressure
time frame: 3 months, 6 months, 12 months
Change in Weight
time frame: 3 months, 6 months, 12 months
Cost effectiveness and cost utility
time frame: 1 year
Change in Cholesterol
time frame: 3 months, 6 months, 12 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Intervention for Diabetes With Education, Advancement and Support (IDEAS) Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Monash University.