Intervention for Diabetes With Education, Advancement and Support

Diabetes Mellitus Clinical Trial

— IDEAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466880
• Other study ID #: IDEAS001
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: March 21, 2017
• Start date: April 2015
• Est. completion date: February 28, 2017

Study information

• Verified date: March 2017
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Telemedicine
A diabetes self-management and education program delivered via telemedicine

Other:
• 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.

Locations

Country	Name	City	State
Malaysia	Klinik Kesihatan Pandamaran	Klang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	MOSTI Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c		3 months, 6 months, 12 months
Secondary	Change in Quality of life - Measured with EQ5D		3 months, 6 months, 12 months
Secondary	Change in Blood pressure		3 months, 6 months, 12 months
Secondary	Change in Weight		3 months, 6 months, 12 months
Secondary	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
Secondary	Change in Cholesterol		3 months, 6 months, 12 months