Clinical trial NCT02466880: Intervention for Diabetes With Education, Advancement and Support
Official title: Intervention for Diabetes With Education, Advancement and Support (IDEAS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Type 2
NIDDM
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: MOSTI Malaysia
First posted: 2015-06-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change in Quality of life - Measured with EQ5D
timeFrame: 3 months, 6 months, 12 months
measure: Change in Blood pressure
timeFrame: 3 months, 6 months, 12 months
measure: Change in Weight
timeFrame: 3 months, 6 months, 12 months
measure: Cost effectiveness and cost utility
timeFrame: 1 year
measure: Change in Cholesterol
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Klang
country: Malaysia
facility: Klinik Kesihatan Pandamaran
state: Selangor
Study officials:
References:
citation: Lee JY, Chan CKY, Chua SS, Paraidathathu T, Lee KK, Tan CSS, Nasir N, Lee SWH. Using telemedicine to support care for people with type 2 diabetes mellitus: a qualitative analysis of patients' perspectives. BMJ Open. 2019 Oct 22;9(10):e026575. doi: 10.1136/bmjopen-2018-026575.
citation: Lee JY, Chan CKY, Chua SS, Ng CJ, Paraidathathu T, Lee KKC, Lee SWH. Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):87-94. doi: 10.1007/s11606-019-05316-9. Epub 2019 Sep 11.
citation: Lee JY, Chan CK, Chua SS, Ng CJ, Paraidathathu T, Lee KK, Lee SW. Intervention for Diabetes with Education, Advancement and Support (IDEAS) study: protocol for a cluster randomised controlled trial. BMC Health Serv Res. 2016 Sep 29;16(1):524. doi: 10.1186/s12913-016-1782-y.