Intervention for Diabetes With Education, Advancement and Support (IDEAS)

M

Monash University

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Other: Usual care
Device: Telemedicine

Study type

Interventional

Funder types

Other

Identifiers

NCT02466880
IDEAS001

Details and patient eligibility

About

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

Enrollment

240 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

240 participants in 2 patient groups

Telemedicine
Experimental group
Description:
Diabetes education and support via telemedicine
Treatment:
Device: Telemedicine
Usual care
Active Comparator group
Description:
Diabetes education and support in person
Treatment:
Other: Usual care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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