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

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ClinicalTrials.gov Identifier: NCT02466880
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
MOSTI Malaysia
Information provided by (Responsible Party):
Shaun Lee Wen Huey, Monash University

Brief 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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Telemedicine Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention for Diabetes With Education, Advancement and Support (IDEAS) Study
Study Start Date : April 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Arm Intervention/treatment
Experimental: Telemedicine
Diabetes education and support via telemedicine
Device: Telemedicine
A diabetes self-management and education program delivered via telemedicine

Active Comparator: Usual care
Diabetes education and support in person
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.




Primary Outcome Measures :
  1. Change in Hemoglobin A1c [ Time Frame: 3 months, 6 months, 12 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466880


Locations
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Malaysia
Klinik Kesihatan Pandamaran
Klang, Selangor, Malaysia, 42000
Sponsors and Collaborators
Monash University
MOSTI Malaysia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shaun Lee Wen Huey, Senior Lecturer, Monash University
ClinicalTrials.gov Identifier: NCT02466880     History of Changes
Other Study ID Numbers: IDEAS001
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in peer review journal
Keywords provided by Shaun Lee Wen Huey, Monash University:
Type 2
NIDDM
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases