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Completed

NCT Number: NCT02466880

Intervention for Diabetes With Education, Advancement and Support

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

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Key information

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Kesihatan Pandamaran

Klang, Selangor, 42000, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

Device

A diabetes self-management and education program delivered via 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.

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: 3 months, 6 months, 12 months

Secondary outcomes

  1. Change in Quality of life - Measured with EQ5D

    Time frame: 3 months, 6 months, 12 months

  2. Change in Blood pressure

    Time frame: 3 months, 6 months, 12 months

  3. Change in Weight

    Time frame: 3 months, 6 months, 12 months

  4. Cost effectiveness and cost utility

    Time frame: 1 year

    The objectives are to compare the results of the study to that of usual care in patients with type 2 diabetes in terms of cost, cost-effectiveness and cost utility of these two strategies.

  5. Change in Cholesterol

    Time frame: 3 months, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • MOSTI Malaysia

Registry information

Official study title

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

Acronym: IDEAS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2015
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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