| Primary | Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors | The sustained (24-month) percentage (%) of participants achieving the outcome in each arm for combined depression and CVD risk factor improvements (≥50% reduction in SCL-20 score AND ≥1 of: ≥0.5% reduction in HbA1c, ≥ 5 mmHg reduction in systolic blood pressure (SBP), or ≥10mg/dl reduction LDL-c). | | Posted | | Number | | percentage of participants | | 24-months post-intervention | | | | ID | Title | Description |
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| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Measures of "Common Effect" | The measure of common effect is a modeled composite estimate of patients achieving simultaneous improvements at 12, 24, and 36 months in the continuous measures for the 4 main outcomes of the trial: depression (20-item Symptoms Checklist [SCL-20] score), glycemia (percentage points in hemoglobin A1c), blood pressure (mmHg of BP), and lipids (mg/dl of LDL-cholesterol).The components of the common effect were standardized differences in each continuous outcome. At each time point, the z-score of each outcome was computed. Next, a model was run to examine the average difference between treatment (intervention) and control in the average level of the standardized outcomes. The estimates are z-score differences in the composite continuous measures of the SCL-20, hemoglobin A1c, systolic BP, and LDL-cholesterol and so, if the intervention group was significantly different (or lower) than the values for the usual care group (control arm), then, the estimates would be negative. | | Posted | | Mean | 95% Confidence Interval | Unitless | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
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| OG000 | Difference Between Intervention Program of Care Arm and Control Arm | The Intervention group includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; supporting Self-Care; psychiatrist and diabetologist reviews; and decision-support Electronic Health Record System The control Group received standard of care and were contacted only at 6 months intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups | Proportion of participants in the intervention and usual care groups that achieved all 3 cardiovascular disease risk factor targets: HbA1c≤7.0% and SBP≤130mmHg and LDL≤100 mg/dl. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
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| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Mean Changes in Each of the Four Main Targets: SCL-20 Score | This outcome was an estimate of mean change, from baseline, of the 20-item Symptoms Checklist Depression Scale (SCL-20; range 0-4; higher scores indicate worse symptoms) for the intervention and usual care groups. The outcome was reported as a change in score from baseline at 12 months, 24 months, and 36 months with 95% confidence intervals. | | Posted | | Mean | 95% Confidence Interval | units on a scale | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Mean Changes in Each of the Four Main Targets: HbA1c | This outcome looked at mean change in one of the four main target outcome indicators: HbA1c in percentage points between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention. | | Posted | | Mean | 95% Confidence Interval | percentage points | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Mean Changes in Each of the Four Main Targets: SBP | This outcome looked at mean change in one of the four main target outcome indicators: Systolic blood pressure (SBP) in mmHg between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention. | | Posted | | Mean | 95% Confidence Interval | mmHg | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl | This outcome looked at mean change in one of the four main target outcome indicators: LDL-c in mg/dl between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention. | | Posted | | Mean | 95% Confidence Interval | mg/dl | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20 | Proportion of participants achieving treatment target or significant reductions in depression control: ≥50% reduction in SCL-20 at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome. | | Posted | | Number | 95% Confidence Interval | % of patients | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control | Proportion of participants achieving a treatment target of HbA1c ≤ 7.0% or ≥ 0.5% reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome. | | Posted | | Number | 95% Confidence Interval | % of patients | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure | Proportion of participants achieving treatment targets or significant reductions of blood pressure (BP) control: Systolic blood pressure (SBP) ≤ 130 mmHg or ≥5 mmHg reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome. | | Posted | | Number | 95% Confidence Interval | % of patients | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control | Proportion of participants achieving treatment targets or significant reductions of lipid control: LDL ≤ 100 mg/dl or ≥ 10mg/dl reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome. | | Posted | | Number | 95% Confidence Interval | % of patients | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Mean Treatment Satisfaction Scores | Mean charges in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in the intervention and usual care groups. Score range is 0-6. Higher score is associated with better outcome. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Mean Health Expenditures (Direct Medical Costs) | Mean of direct medical costs for consultations, diagnostic tests, medications, hospital admissions, and/or surgeries or procedures) among participants in the treatment and usual care groups. | | Posted | | Mean | Standard Deviation | Indian Rupees | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Program of Care | Includes 4 components:
- Patient Education and Behavioral Activation by a Care Coordinator;
- Supporting Self-Care;
- Psychiatrist and Diabetologist Reviews; and
- Decision-support Electronic Health Record System
| | OG001 | Control Arm | Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor. |
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| Secondary | Cost Utility in the Treatment Arm and Usual Care Arms | The ratio of total costs, which include health expenditures by participants plus clinic or study costs to deliver the intervention and the relative gain or loss in health utilities (measured by the health utilities index). The within-trial cost-utility of intervention was compared to usual care, an incremental cost-utility ratio will be calculated [net costs to net utility: costs(intervention) - costs(control) / utility(intervention) - utility(control)]. The chosen measure of utility is the closest option to a global measure, the quality adjusted life year [QALY] and is calculated as the sum of mean survival time [life years] x utility scores at 6, 12, 18, 24 and 36 months. | Results analyzed at 24 and 36 months post-intervention. Cost Utility was not collected at 12 months post-intervention. | Posted | | Number | | INR/QALY | | 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) | | | | ID | Title | Description |
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| OG000 | Incremental Cost Utility Ratio | Includes participants in both study groups: Intervention and Control group |
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