Trial Outcomes & Findings for INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study (NCT NCT02022111)
NCT ID: NCT02022111
Last Updated: 2021-05-03
Results Overview
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).
COMPLETED
NA
404 participants
24-months post-intervention
2021-05-03
Participant Flow
Once informed consent was obtained, a blinded outcomes assessor conducted a detailed baseline assessment. Following this, blinded study staff assigned participants to receive intervention or usual care using a password-protected web-based data management system (Interactive Web Response System \[IWRS\]).
Participant milestones
| Measure |
Intervention Program of Care
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
196
|
208
|
|
Overall Study
COMPLETED
|
186
|
193
|
|
Overall Study
NOT COMPLETED
|
10
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
Baseline characteristics by cohort
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
196 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
196 participants
n=5 Participants
|
208 participants
n=7 Participants
|
404 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24-months post-interventionThe 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).
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors
|
71.6 percentage of participants
|
54.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=404 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
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.
|
|---|---|---|
|
Measures of "Common Effect"
12 months post-intervention
|
-0.2250 Unitless
Interval -0.3303 to -0.1197
|
—
|
|
Measures of "Common Effect"
24 months post-intervention
|
-0.1118 Unitless
Interval -0.2254 to 0.0018
|
—
|
|
Measures of "Common Effect"
36 months post-intervention
|
0.0434 Unitless
Interval -0.088 to 0.1749
|
—
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups
12 months post-intervention
|
15.3 percentage of participants
Interval 10.1 to 20.4
|
5.5 percentage of participants
Interval 2.3 to 8.7
|
|
Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups
24 months post-intervention
|
7.10 percentage of participants
Interval 3.3 to 10.8
|
7.30 percentage of participants
Interval 3.6 to 11.1
|
|
Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups
36 months post-intervention
|
3.10 percentage of participants
Interval 0.4 to 5.9
|
2.40 percentage of participants
Interval 0.1 to 4.8
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Mean Changes in Each of the Four Main Targets: SCL-20 Score
12 months Post-intervention SCL-20
|
-0.79 units on a scale
Interval -0.86 to -0.72
|
-0.55 units on a scale
Interval -0.64 to -0.46
|
|
Mean Changes in Each of the Four Main Targets: SCL-20 Score
24 months Post-intervention SCL-20
|
-0.94 units on a scale
Interval -1.02 to -0.86
|
-0.86 units on a scale
Interval -0.95 to -0.76
|
|
Mean Changes in Each of the Four Main Targets: SCL-20 Score
36 months Post-intervention SCL-20
|
-0.93 units on a scale
Interval -1.03 to -0.83
|
-0.96 units on a scale
Interval -1.06 to -0.87
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Mean Changes in Each of the Four Main Targets: HbA1c
12 months Post-intervention HbA1c
|
-1.12 percentage points
Interval -1.39 to -0.85
|
-0.54 percentage points
Interval -0.78 to -0.29
|
|
Mean Changes in Each of the Four Main Targets: HbA1c
24 months Post-intervention HbA1c
|
-0.49 percentage points
Interval -0.77 to -0.21
|
-0.24 percentage points
Interval -0.48 to 0.01
|
|
Mean Changes in Each of the Four Main Targets: HbA1c
36 months Post-intervention HbA1c
|
0.12 percentage points
Interval -0.78 to 1.02
|
-0.02 percentage points
Interval -0.31 to 0.28
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Mean Changes in Each of the Four Main Targets: SBP
12 months Post-intervention SBP
|
-6.95 mmHg
Interval -9.62 to -4.27
|
-5.91 mmHg
Interval -8.18 to -3.65
|
|
Mean Changes in Each of the Four Main Targets: SBP
24 months Post-intervention SBP
|
-9.81 mmHg
Interval -13.0 to -6.65
|
-9.12 mmHg
Interval -12.3 to -5.93
|
|
Mean Changes in Each of the Four Main Targets: SBP
36 months Post-intervention SBP
|
-2.43 mmHg
Interval -4.93 to 0.07
|
-3.69 mmHg
Interval -6.49 to -0.88
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl
12 months Post-intervention LDL-c
|
-9.47 mg/dl
Interval -15.3 to -3.66
|
-7.04 mg/dl
Interval -12.3 to -1.79
|
|
Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl
24 months Post-intervention LDL-c
|
-5.10 mg/dl
Interval -10.9 to 0.69
|
-5.16 mg/dl
Interval -11.2 to 0.89
|
|
Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl
36 months Post-intervention LDL-c
|
9.33 mg/dl
Interval 2.16 to 16.51
|
7.65 mg/dl
Interval 0.85 to 14.44
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20
SCL-20 12 months -Post-intervention
|
75.0 % of patients
Interval 68.8 to 81.2
|
48.0 % of patients
Interval 41.1 to 55.0
|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20
SCL-20 24 months -Post-intervention
|
82.9 % of patients
Interval 77.3 to 88.4
|
68.8 % of patients
Interval 62.1 to 75.4
|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20
SCL-20 36 months -Post-intervention
|
75.2 % of patients
Interval 68.3 to 82.0
|
73.3 % of patients
Interval 66.5 to 80.2
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control
HbA1c 12 months -Post-intervention
|
69.6 % of patients
Interval 63.1 to 76.2
|
52.5 % of patients
Interval 45.5 to 59.4
|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control
HbA1c 24 months -Post-intervention
|
53.9 % of patients
Interval 46.5 to 61.2
|
49.0 % of patients
Interval 41.8 to 56.1
|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control
HbA1c 36 months -Post-intervention
|
50.0 % of patients
Interval 42.1 to 57.9
|
46.4 % of patients
Interval 38.7 to 54.1
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure
BP 12 months -Post-intervention
|
71.9 % of patients
Interval 65.5 to 78.3
|
73.8 % of patients
Interval 67.6 to 79.9
|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure
BP 24 months -Post-intervention
|
74.6 % of patients
Interval 68.2 to 81.0
|
77.0 % of patients
Interval 70.9 to 83.0
|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure
BP 36 months -Post-intervention
|
63.4 % of patients
Interval 56.0 to 70.9
|
73.7 % of patients
Interval 66.9 to 80.4
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control
Lipid Control 12 months -Post-intervention
|
72.6 % of patients
Interval 66.2 to 79.0
|
69.8 % of patients
Interval 63.4 to 76.3
|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control
Lipid Control 24 months -Post-intervention
|
66.9 % of patients
Interval 59.9 to 73.8
|
66.5 % of patients
Interval 59.7 to 73.2
|
|
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control
Lipid Control 36 months -Post-intervention
|
49.7 % of patients
Interval 41.9 to 57.5
|
56.4 % of patients
Interval 48.7 to 64.0
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Mean Treatment Satisfaction Scores
24 months -Post-intervention
|
2.22 score on a scale
Interval 1.25 to 3.18
|
1.16 score on a scale
Interval 0.34 to 1.97
|
|
Mean Treatment Satisfaction Scores
36 months -Post-intervention
|
3.43 score on a scale
Interval 2.48 to 4.39
|
3.45 score on a scale
Interval 2.59 to 4.31
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)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.
Outcome measures
| Measure |
Intervention Program of Care
n=196 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
Control Arm
n=208 Participants
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.
|
|---|---|---|
|
Mean Health Expenditures (Direct Medical Costs)
Cost at 12 months -Post-intervention
|
23423.70 Indian Rupees
Standard Deviation 11111.54
|
8674.35 Indian Rupees
Standard Deviation 6026.47
|
|
Mean Health Expenditures (Direct Medical Costs)
Cost at 24 months -Post-intervention
|
32119.20 Indian Rupees
Standard Deviation 14371.06
|
17957.99 Indian Rupees
Standard Deviation 10813.52
|
|
Mean Health Expenditures (Direct Medical Costs)
Cost at 36 months -Post-intervention
|
41808.22 Indian Rupees
Standard Deviation 17848.54
|
28242.58 Indian Rupees
Standard Deviation 15241.46
|
SECONDARY outcome
Timeframe: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)Population: Results analyzed at 24 and 36 months post-intervention. Cost Utility was not collected at 12 months post-intervention.
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.
Outcome measures
| Measure |
Intervention Program of Care
n=404 Participants
Includes 4 components:
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
|
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.
|
|---|---|---|
|
Cost Utility in the Treatment Arm and Usual Care Arms
Health utilities index at 24 months post-intervention
|
155,106.5 INR/QALY
|
—
|
|
Cost Utility in the Treatment Arm and Usual Care Arms
Health utilities index at 36 months post-intervention
|
121,993.2 INR/QALY
|
—
|
Adverse Events
Intervention Program of Care
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place