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Diabetes MellitusIDEASNCT02466880

Intervention for Diabetes With Education, Advancement and Support

A study testing Telemedicine in people with Diabetes Mellitus, run by Monash University at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Telemedicine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteMalaysia
Study dates
Apr 2015to 28 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Klinik Kesihatan Pandamaran

    Klang, Selangor, 42000

Other trials in Malaysia

About this study

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

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

Being tested
Telemedicine, Usual care
Keywords
Type 2, NIDDM
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemedicineDevice

    A diabetes self-management and education program delivered via telemedicine

  • Usual careOther

    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.

Study groups in NCT02466880
Study groupRoleWhat they receive
TelemedicineExperimentalDiabetes education and support via telemedicine
Receives: Device: Telemedicine
Usual careActive comparatorDiabetes education and support in person
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hemoglobin A1c

    Measured: 3 months, 6 months, 12 months

Secondary outcomes (5)

  1. Change in Quality of life - Measured with EQ5D

    Measured: 3 months, 6 months, 12 months

  2. Change in Blood pressure

    Measured: 3 months, 6 months, 12 months

  3. Change in Weight

    Measured: 3 months, 6 months, 12 months

  4. 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.

    Measured: 1 year

  5. Change in Cholesterol

    Measured: 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion28 Feb 2017
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02466880
Sponsor's protocol ID
IDEAS001
Acronym
IDEAS
Status last verified
Mar 2017
First submitted
2 Jun 2015
Last updated
22 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Publication in peer review journal

Publications

  • 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.

    PubMed 31640990

  • 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.

    PubMed 31512187

  • 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.

    PubMed 27683021

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine in people with Diabetes Mellitus, run by Monash University at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c (time frame: 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02466880, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.

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