Center Protocols

The New Delhi Center of Excellence at the Public Health Foundation of India enacted three protocols:

Protocol 1
Center for cardio metabolic Risk Reduction in South Asia (CARRS): Surveillance Study

Protocol 2
Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translational Trial)

Protocol 3
Solan Surveillance Study (SSS)

Objectives

Protocol 1
To develop a model surveillance system for cardio-metabolic diseases (CMD) and their risk factors which can be adopted for continuing surveillance by other countries in South East Asia. To measure the incidence of CMD risk factors and disease events, as well as the associated morbidity and mortality.

Protocol 2
To test whether an intensive and comprehensive health care intervention to reduce cardiovascular disease (CVD) risk among type 2 diabetes patients in South Asia is more effective and sustainable compared to existing care.

Protocol 3
To develop a model surveillance system for cardio-metabolic diseases (CMD) and their risk factors in rural India. To measure the incidence of CMD risk factors and disease events, as well as the associated morbidity and mortality.

Background

Cardio-metabolic diseases (CMDs) include diabetes mellitus, cardiovascular disease, kidney disease and common risk factors that underlie these conditions such as central obesity, insulin resistance, glucose intolerance, dyslipidemia, and hypertension. CMDs are a growing global public health problem, with high mortality rates particularly in low- and middle-income countries. However, CMDs have the advantage of being predictable through identification of risk factors and also preventable through changes in lifestyle, particularly through healthy eating habits and regular physical activity. The greatest gains in prevention have been seen when early and target-driven interventions address multiple risk factors. However, achieving control of individual risk factors is poor, globally. Quality improvement schemes have shown promise in high-income countries, but were untested in South Asia at the time of these studies.

In people of South Asian origin, diabetes, and CMD risk factors and events occur at younger ages and lower body mass indices when compared to other ethnic groups, and are rapidly increasing with socioeconomic and nutrition transitions. CVD is currently the leading cause of death in both urban and rural India. Prior to these studies, the major source of population level estimates of CMD risk factors, morbidity and mortality in India was ad hoc surveys. Such methods are limited by problems of sample design, lack of standardization, frequent measurement errors and incomplete reporting of results. A surveillance model of study would allow for more extensive comprehension of the distribution and trends of determinants and disease, dynamic integration of information from multiple sources, and aid in the development of safe, effective prevention and care models.

Participants

Protocol 1
Households within each study site were randomly selected. Any non-pregnant individuals permanently residing in the household and at least 20 years of age were eligible for enrollment. 4,943 participants from Chennai, 4,425 participants from New Delhi, and 4,016 participants from Karachi were enrolled in the first surveillance cohort. The study aimed to recruit 6,500 new participants at each of the three sites for the second cohort.

Protocol 2
Eligible patients were at least 35 years of age with a diagnosis of diabetes, poor glycemic control (HbA1c ≥ 8.0%), and one or both of: dyslipidemia (LDL ≥ 130 mg/dl) or systolic hypertension (SBP ≥ 140 mmHg), irrespective of medication use. The study enrolled a total of 1,146 patients from ten clinical sites, with 575 randomized to the intervention group and 571 randomized to the usual care group.

Protocol 3
Participants were recruited from 38 sub-centers in the Solan district located in the Indian state of Himachal Pradesh. All community members, aged 20 years or older and permanently residing in well-defined rural communities in the selected geographical areas, were eligible to participate.

Design

Protocols 1/3
The Solan Surveillance study was the rural counterpart of CARRS Surveillance study, and therefore they used similar methodology. The CARRS surveillance study was conducted in three sites: two in India (Chennai and New Delhi) and one in Pakistan (Karachi). The Solan Surveillance study was conducted in the Solan District of Himachal Pradesh, India. Recruitment occurred and data were collected via household surveys. While the primary study design for the surveillance model was cross-sectional, a cohort study design was used to follow-up the participants for three to four years subsequent to the initial cross-sectional study. Baseline surveys gathered information on demographic and socio-economic characteristics, presence of CMDs and risk factors, previous or existing target organ damage, female reproductive history, quality of life, disability, health care utilization, and quality and cost of care. Additional clinical measurements included blood pressure, pulse rate, mid-arm circumference, waist circumference, hip circumference, skinfold thickness, height, and body composition. Each surveillance study implemented a second independent cross-sectional survey several years after the first in order to estimate the trend in prevalence of CMDs and their risk factors. Outcomes of interest included anthropometric changes; incidence of new intermediate risk factors or changes in pre-existing risk factors such as dyslipidemia, hypertension, and diabetes; and morbidity and mortality associated with CMDs.

Protocol 2
The CARRS Translational trial was a multi-site, individually randomized, controlled parallel group study that tested a comprehensive, multi-factorial CVD risk reduction intervention in type 2 diabetes patients attending established out-patient clinics in South Asia. The intervention strategies followed internationally accepted evidence-based CVD risk management algorithm-guidelines for individuals with diabetes, with adaptations to increase relevance to the South Asian population. The intervention utilized two major health care management strategies: (1) a web-enhanced decision-support software to store patient health records, provide automated decision-support prompts for patient management, and remind providers and participants of the guideline-recommended care processes, and (2) a non-physician care coordinator to facilitate care according to the CVD risk factor management guidelines, provide individualized follow-up according to baseline risk and compliance, empower and encourage patients to achieve management targets, and coordinate guidance from a multi-disciplinary team. The control group received the existing standard care existing at the clinical site.

Potential participants were invited for two pre-randomization screening visits to assess history, anthropometry, blood pressure, heart rate, and to collect a fasting venous blood sample for glucose, HbA1c, lipid profile, creatinine, potassium, sodium, and ALT measurements. At the baseline/randomization visit, all participants underwent further assessments including a detailed history and physical examination, questionnaires (self-management, quality of life, treatment satisfaction, and cost of care), and preventive exams including urine analysis, electrocardiogram, and foot and eye examinations. Participants in the intervention group were scheduled for follow-up every three months, and participants in the control group were scheduled for yearly follow-up. Median follow-up was 28 months. The primary outcome was a sustained relative difference in those achieving multiple risk factor targets (glycemic and BP or lipid control, or both) in the intervention group, compared to the control group.

Conclusions

Protocol 1
Not available

Protocol 2
Compared with usual care, intervention participants achieved larger reductions in HbA1c level and reported higher health related quality of life and treatment satisfaction. The multicomponent care management strategy improved achievement of diabetes care goals.

Protocol 3
Not available

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