Introduction

Globally, India is estimated to have the highest burden of Tuberculosis (2.2 million cases, 2010)¹ and second highest prevalence of Diabetes Mellitus (63 million, 2012)². Studies have shown that the rates of tuberculosis (TB) are higher in people with diabetes mellitus (DM) than in the general population^3-5. DM can worsen the clinical course of TB, and TB can worsen glycaemic control in people with diabetes⁶.

In India, TB is managed through the ‘Directly observed therapy, short-term’ (DOTS) clinics which have enabled effective large-scale delivery of anti-tuberculous therapy ⁷. While there are clear guidelines for the management of patients with TB, there are no clear strategies for the management of individuals with TB and diabetes. The World Health Organisation and International Union against Tuberculosis recommends screening patients with TB for DM at the initiation of treatment⁸. There are few pilot studies which screen TB patients for DM^{5, 9}, but none of them have documented the feasibility of managing TB patients with DM in the Indian healthcare setting. Operational research is needed to determine the best way to manage individuals with both conditions. Access to these patients through DOTS centers might provide opportunity to deliver appropriate diabetes care with emphasis on risk-factor mitigation, education and treatment adherence. 

Aim: This proposal aims to develop and field test an integrated, multidisciplinary program addressing the management of individuals with TB and DM and other associated chronic conditions in the Indian primary healthcare setting.  

Methods

Study design: Randomised control feasibility study

Intervention: The strategy will be based on the Indian chronic disease management guidelines and revised national tuberculosis control program (RNTCP) and will be field tested in 10 DOTS clinics with a team of NPHWs using electronic decision support tools. All patients newly diagnosed with TB or on treatment for less than 4 months will be screened for DM and associated cardiovascular risk factors.  Those with newly diagnosed diabetes or significant cardiovascular risk factors (eg. hypertension) will be referred to the local primary health centre for the initiation of treatment. NPHWs will be trained to follow-up patients for a period of 8 months from study enrolment to encourage treatment adherence, monitor treatment response including blood glucose levels and provide lifestyle advice.

Evaluation: An open, randomised controlled trial will be piloted and a mixed-methods process evaluation conducted. A preliminary estimate of the effectiveness will assess the proportion of TB patients newly identified with DM and prescribed guideline recommended treatment. A secondary outcome will include adherence to treatment, including drugs for tuberculosis and associated chronic diseases (diabetes, hypertension etc.) at 5 and 8 months. In-depth interviews will be conducted with healthcare teams and patients to assess the acceptability and feasibility of such an approach and explore the barriers and enablers of the integrated disease management approach.

Expected Outcomes

The main outcomes of the study are to:

a)    describe  the prevalence DM and other CVD risk factors among patients treated for TB

b)    explore the feasibility of an integrated screening and management approach for chronic diseases, including HIV, DM and cardiovascular risk factors in TB patients

c)    increase the proportion of TB patients with HIV/ diabetes/ cardiovascular risk factors on recommended therapies in the intervention arm

d)    improve awareness and disease knowledge of diabetes and cardiovascular risk factors among health care workers,  TB patients and the general community in the intervention arm

The implementation of new interventions can create significant demands on health systems especially in resource constrained settings which often lack infrastructure, staffing and organisational capacity. The formative research outlined can identify and address sources of potential intervention success or failure and ensure that the substantial investment in a subsequent trial is optimised.