Health Condition 1: null- Cardiometabolic diseases - Type 2 diabetes mellitus Health Condition 2: E115- Type 2 diabetes mellitus with circulatory complications
Conditions
Interventions
Intervention1: Electronic Health Records- Decision Support Software (EHR-DSS)
Non-Physician care coordinator
management guidelines: Duration-3-3.5 years
Control Intervention1: Usual Care: Usual Care
Sponsors
National Heart Lung and Blood Institute National Institutes for Heath USA
Ovations, United Health Group
Contact Person: Richard Smith,
Director of United Health Chronic Disease Initiative, London, UK
email id: richardswsmith@yahoo.co.uk
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 35 years and older 2. Confirmed diagnosis of diabetes based on documented evidence from oral glucose tolerance test or two venous fasting blood sugar levels or known diabetes patient on medication or insulin 3. Poor glycemic control (as evidenced by HbA1c greater than or equal to 8.0%) AND one or both of: dyslipidemia (LDL greater than or equal to 130 mg/dl) or systolic hypertension (SBP greater than or equal to 140 mmHg), irrespective of lipid- or BP-lowering medication use, respectively 4. Receiving diabetes care in the same clinic for at least 3 months OR even earlier if in the investigators assessment the patient is likely to follow-up regularly as required by the protocol. 5. Willingness to consent to randomization Note- The trial has no upper age limit.
Exclusion criteria
Exclusion criteria: Individuals will be excluded from participation if any of the following are present during screening: 1. Known type 1 diabetes mellitus 2. Diabetes secondary to chronic pancreatitis 3. Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods) 4. Evidence of pre-existing well-controlled blood glucose, blood pressure or LDL-cholesterol (as evidenced by HbA1c < 7.0%, SBP < 130 mmHg, LDL-cholesterol < 100 mg/dl [LDL-cholesterol < 70 mg/dl with history of CVD event]) obtained from screening within a period not exceeding 28 days (4 weeks) prior to randomization 5. Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12 months 6. Current symptomatic CHF or NYHA Class 3 or 4 effort intolerance 7. Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy [dialysis or transplant]) 8. Transaminase >3 times upper limit of normal OR active liver disease within past 2 years 9. Malignancy or life-threatening disease with death probable in 4 years 10. Any current medication (e.g. long-term steroids, protease inhibitors) that, in the opinion of the site investigator, would interfere with participant?s diabetic status and follow-up 11. Any condition or circumstance that is unrelated to diabetes progression, that in the opinion of the site investigator would interfere with the participant?s diabetic status and follow-up: including (but not limited to) other endocrinopathy [adrenal, pituitary], TB patient on treatment, psychiatric illness or cognitive impairment, alcohol or drug abuse, history of organ transplant, BMI >= 45 kg/m2 12. On an investigational drug in the last 3 months 13. Currently participating in a clinical trial 14. No fixed address or contact details 15. Plans to move in the next 3 years 16. A member of the participant?s household is currently in the trial 17. Inability or unwillingness of individual or legal guardian /representative to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study has one primary outcome of interest, multiple CVD risk factor control targets: at least two targets including HbA1c 7.0% and at least one of: BP 130/80 mmHg or LDL-cholesterol 100 mg/dl (LDL cholesterol 70 mg/dl for those with history of CVD event).Timepoint: Baseline, 3 monthly (for intervention arm only), Annually & End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Single risk factor control targets, as demonstrated by: (a) at least an absolute 10% point greater proportion of participants in the intervention group achieving good glycemic control (HbA1c < 7%); (b) at least an absolute 10% point greater proportion of participants in the intervention group achieving blood pressure control (systolic BP < 130 and diastolic BP < 80 mmHg); and (c) at least an absolute10% point greater proportion of participants in the intervention group achieving lipid control (LDL-cholesterol < 100 mg/dl; < 70 mg/dl for those with history of CVD event) (2) Quality of care measures, as demonstrated by participant and provider adherence to: (a) currently advocated CVD risk factor management guidelines (i.e. proportion of patients prescribed and/or using lipid-or BP-lowering medication, where indicated; proportion of participants smoking who have stopped; proportion of patients who were given lifestyle modification advice and/or adhering to dietary and physical activity targets) and (b) evidence-based processes of care (i.e. use of aspirin and/or RAS-modifiers; and annual eye, foot, dental and urine examinations); (c) Assessment methods: i. Participant Perspective (Self-management):Summary of Diabetes Self-Care Activities (SDSCA) ii. Provider Perspective: Electronic Health Records from DSS (Documentation by Care Coordinator and Research Officer) (3) Patient-related outcomes of: (a) Participant health-related quality of life (QoL) i. Event-related: European Quality of Life 5 Dimensions (EQ-5D) ii. General: Health Utility Index (HUI-3) (b) Treatment satisfaction i. Diabetes Treatment Satisfaction Questionnaire (DTSQ) (4) To evaluate the sustainability of the intervention using the following methods: (a) Cost-effectiveness of the intervention by assessing the incremental costs and benefits of the intervention versus standard care for the clinic facility. i. Questionnaire: Frequency/Costs of Care ii. Electronic health | — |
Countries
India
Contacts
Public ContactKavita Singh
All India Institute of Medical Sciences
Outcome results
None listed