- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02466880
Intervention for Diabetes With Education, Advancement and Support (IDEAS)
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Selangor
-
Klang, Selangor, Malaysia, 42000
- Klinik Kesihatan Pandamaran
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Usual care
Diabetes education and support in person
|
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.
|
|
Experimentell: Telemedicine
Diabetes education and support via telemedicine
|
A diabetes self-management and education program delivered via telemedicine
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in Hemoglobin A1c
Tidsram: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Quality of life - Measured with EQ5D
Tidsram: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
|
|
Change in Blood pressure
Tidsram: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
|
|
Change in Weight
Tidsram: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
|
|
Cost effectiveness and cost utility
Tidsram: 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.
|
1 year
|
|
Change in Cholesterol
Tidsram: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IDEAS001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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