Simplified Cardiovascular Management (SimCard) Study in ... · CVD high- risk. Meeting any one of the following conditions: • History of diabetes • History of stroke • History

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Dr. Maoyi Tian on behalf of SimCard working group

Simplified Cardiovascular Management (SimCard) Study in Tibet, China and Haryana, India

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24million

80% LMIC

40%

Background – CVD

17millionChina

IndiaTibet

Haryana

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• To develop,• Pilot-test and • Evaluate the feasibility and effectiveness of a

SIMPLIFIED, but GUIDELINE-BASED cardiovascular disease management program delivered by the COMMUNITY HEALTH WORKERS (CHWs) in resource-constrained settings in Tibet, China and Haryana, India

Aim

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Inclusion criteria

• Age ≥ 40

• Resident in the selected village

Screening

Method – subjects

Single-blinded cluster randomized controlled trial (47 clusters)

Exclusion criteria

• Bed-ridden • Unable to stay >8 months in a year

• Life-threatening disease • CVD related complications that can’t be managed

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Screening

Non CVDHigh-risk

CVD High-risk Baseline

Usual Care(24 clusters)

1-year Intervention(23 clusters)

Follow-up

Method – design

CVD high-riskMeeting any one of the following conditions:

• History of diabetes

• History of stroke

• History of coronary heart disease

• Both SBP ≥ 160mmHg at two different time points in the same day during the survey

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Salt Reduction

SmokingCessation

BP lowering

agentAspirin

2 Lifestyle Modifications

2 Drug Prescriptions

Electronic Decision Support System

(EDSS)

Method – intervention

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Method – outcome

• Primary outcome:The binary outcome of anti-hypertensive medication use of all high-risk

individuals. The significance test is for the net difference in the proportion of anti-hypertensive medication use between the groups.

• Secondary outcomes:• The binary outcome of aspirin use of all high-risk individuals;• The difference in pre-and-post mean SBP of high-risk individuals. • Others

• Outcome evaluation:• Baseline and post-intervention follow-up survey• Identical standardized instruments for both surveys

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Method – statistical analysis

• Power (>90%)• Primary outcome: assuming 20% in control group, detect a 10% difference ,

ICC=0.02• Secondary outcome: assuming SD of the change in SBP =15mmHg, detect a

3mmHg difference, ICC=0.02• Adequate power for sub-group analysis by country

• Method• Intent-to-treat using last observation carried forward• Analysis accounts for cluster effect and repeated measurements• Mixed models were used – logistic model (binary), linear model (continuous)

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Enrollment

Allocation

Follow-up

Analysis

Result – flow chart

52 villages (China: 30, India: 32)

5 villages were excluded

47 villages were recruited. 2,086 high-risks were identified (China: 1,036, India: 1,050) as high-risk.

Intervention Group1,095 high-risks from 23 villages

(China: 557, India: 538)

Control Group991 high-risks from 24 villages

(China: 479, India: 512)

962 high-risks from 23 villages (China: 478, India: 484)

866 high-risks from 24 villages (China: 431, India: 435)

IIT: 1,095 were analyzed. IIT: 991 were analyzed.

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Result – baseline characteristics

Characteristics (Mean, SD or %)Total

Intervention Control

Age (years) 59.7, 11.7 60.4, 11.8

Female (%) 65.4 66.8

Illiterate (%) 59.3 61.9

Body mass index (kg/m2) 23.6, 4.2 24.0, 4.4

Current smoker (%) 36.7 37.5

Coronary heart disease (%) 39.5 31.9

Stroke (%) 10.4 9.9

Diabetes (%) 13.4 9.8

Characteristics (Mean, SD or %)China


Age (years) 59.5, 11.6 59.3, 11.3

Female (%) 72.0 70.8





Stroke (%) 6.8 9.4

Diabetes (%) 2.9 1.9

Characteristics (Mean, SD or %)India


Age (years) 59.9, 11.8 61.5, 12.1

Female (%) 58.6 63.1





Stroke (%) 14.1 10.4

Diabetes (%) 24.3 17.2

Characteristics (Mean, SD or %)India


Age (years) 59.9, 11.8 61.5, 12.1

Female (%) 58.6 63.1





Stroke (%) 14.1 10.4

Diabetes (%) 24.3 17.2

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Result – primary outcome

Total China India

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Result – secondary outcomes

Total Aspirin (%)

SBP (mmHg)

Current smoker (%)

Awareness of high salt harm (%)

InterventionPre 6.0 161.3, 29.6 36.7 46.9

Post 18.8 151.0, 27.0 37.7 59.6

ControlPre 4.7 161.4, 27.8 37.5 36.8

Post 2.8 153.2, 27.7 36.7 55.8

Net 11.7 -2.1 1.8 -6.3

P value <0.001 0.03 0.46 0.08

Total Aspirin (%)

SBP (mmHg)

Current smoker (%)



Post 18.8 151.0, 27.0 37.7 59.6

ControlPre 4.7 161.4, 27.8 37.5 36.8

Post 2.8 153.2, 27.7 36.7 55.8

Net 11.7 -2.1 1.8 -6.3

P value <0.001 0.03 0.46 0.08

China Aspirin (%)

SBP (mmHg)

Current smoker (%)



Post 23.7 155.3, 27.8 38.8 87.1

ControlPre 5.6 164.4, 28.8 36.2 52.9

Post 1.9 157.3, 29.2 36.1 76.2

Net 20.4 -3.8 1.4 -0.3

P value <0.001 0.006 0.65 0.19

China Aspirin (%)

SBP (mmHg)

Current smoker (%)



Post 23.7 155.3, 27.8 38.8 87.1

ControlPre 5.6 164.4, 28.8 36.2 52.9

Post 1.9 157.3, 29.2 36.1 76.2

Net 20.4 -3.8 1.4 -0.3

P value <0.001 0.006 0.65 0.19

India Aspirin (%)

SBP (mmHg)

Current smoker (%)



Post 13.8 146.6, 25.3 36.5 31.1

ControlPre 3.7 158.5, 26.5 38.7 21.4

Post 3.7 149.5, 25.7 37.2 36.7

Net 8.8 -0.5 2.1 -13.3

P value <0.001 0.71 0.22 <0.001

India Aspirin (%)

SBP (mmHg)

Current smoker (%)



Post 13.8 146.6, 25.3 36.5 31.1

ControlPre 3.7 158.5, 26.5 38.7 21.4

Post 3.7 149.5, 25.7 37.2 36.7

Net 8.8 -0.5 2.1 -13.3

P value <0.001 0.71 0.22 <0.001

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Result - summary

• Effectively changed CHWs and patients' behaviors in increasing

uptake of evidence-based medicine (anti-hypertensive medication

and aspirin)

• No significant changes in lifestyle factors

• Reduced systolic blood pressure by 2.1 mmHg

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Strength/Limitation

• Strength• Strong local government support• Adaptive intervention design in two countries• Active engagement of the CHWs• The use of EDSS

• Limitation• Generalizability• Unable to distinguish the effectiveness of different

intervention component

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Conclusion

Simplified evidence-based culturally-appropriate interventions

based on the high-risk approach could improve quality of primary

care and have the potential to reduce disease burden in resource-

constrained settings.

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• Collaborators

o Tibet University

o Public Health Foundation of India

o China Mobile Research Institute

o University of Oxford

• Funding source

National Heart, Lung, and Blood Institute (National Institutes of Health)

Acknowledgement

China site:Z Liu, D Dunzhu, X Zhao, H Chen, K ChoR Li, C Li, X Li, J Ji, E Delong, E PetersonY Wu, L Yan

India site:V Ajay, S Hameed, D JindalI Rawal, M Ali, R AmachandA Krishnan, N Tandon, D Prabhakaran

Simplified Cardiovascular Management (SimCard) Study in ... · CVD high- risk. Meeting any one of the following conditions: • History of diabetes • History of stroke • History

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