Intervention for Diabetes With Education, Advancement and Support

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Telemedicine
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>Diabetes education and support via telemedicine | Device: Telemedicine<br>* A diabetes self-management and education program delivered via telemedicine<br>|
| Active Comparator: Usual care<br>Diabetes education and support in person | Other: Usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c |  | 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 1 year | 
| Change in Cholesterol |  | 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2, NIDDM