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CTRI Number  CTRI/2017/10/010199 [Registered on: 25/10/2017] Trial Registered Retrospectively
Last Modified On: 30/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Diabetes and Tuberculosis - Integrated management using the primary healthcare infrastructure in India 
Scientific Title of Study   Integrated chronic disease management using the primary healthcare infrastructure in India – a feasibility 
Trial Acronym  ICDM 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Praveen Devarsetty 
Designation  Program Head - Primary Healthcare Research 
Affiliation  The George Institute for Global Health, India 
Address  The George Institute for Global Health, India, 301, Second floor, ANR Center, Road no 1, Banjara Hills, Hyderabad - 500034

Hyderabad
ANDHRA PRADESH
500034
India 
Phone    
Fax    
Email  dpraveen@georgeinstitute.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Praveen Devarsetty 
Designation  Program Head - Primary Healthcare Research 
Affiliation  The George Institute for Global Health, India 
Address  The George Institute for Global Health, India, 301, Second floor, ANR Center, Road no 1, Banjara Hills, Hyderabad - 500034

Hyderabad
ANDHRA PRADESH
500034
India 
Phone    
Fax    
Email  dpraveen@georgeinstitute.org.in  
 
Details of Contact Person
Public Query
 
Name  Praveen Devarsetty 
Designation  Program Head - Primary Healthcare Research 
Affiliation  The George Institute for Global Health, India 
Address  The George Institute for Global Health, India, 301, Second floor, ANR Center, Road no 1, Banjara Hills, Hyderabad - 500034

Hyderabad
ANDHRA PRADESH
500034
India 
Phone    
Fax    
Email  dpraveen@georgeinstitute.org.in  
 
Source of Monetary or Material Support  
George Institute for Global Health, 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi 110025 | India 
 
Primary Sponsor  
Name  The George Institute for Global Health 
Address  The George Institute for Global Health, INDIA, 301, Second floor, ANR centre, Road no 1, Banjara Hills, Hyderabad - 500034 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen Devarsetty  Primary health care facility, Guntur  Andhra Pradesh, India
Guntur
ANDHRA PRADESH 
914030994444

dpraveen@georgeinstitute.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Centre for Chronic Disease Control- Independent Ethics Committee (CDC-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Patients diagnosed with Tuberculosis from the DOTS centre, (1) ICD-10 Condition: A15-A19||Tuberculosis, (2) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Screening and management for Diabetes  Patients with TB will be additionally screened for DM by ANMs and referred to PHC for management 
Comparator Agent  Usual course  No additional screening and follow-up 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients with Tuberculosis 
 
ExclusionCriteria 
Details  a. Individuals below 18 years
b. People with intellectual disability that prevents them from comprehending the study principles and requirements
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Development of a complex intervention: including the following
1.1 Clinical decision support systems using available national guidelines for the co-management of TB, diabetes and CVD
1.2 Electronic patient records in order to follow up patients in the community
2. Defining the prevalence of DM and CVD risk in patients with TB.
3. Demonstrating feasibility, acceptability and effectiveness
 
Phase 1 (0-2 months)
Development of clinical tools and randomisation.

Phase 2 (3-4 months)
Recruitment of participants and baseline data collection.

Phase 3 (5-16 months)
Implementation of the pilot intervention.

Phase 4 (17-18 months)
End of study data collection.

 
 
Secondary Outcome  
Outcome  TimePoints 
Detailed process evaluation  end of the study (January 2018) 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2016 
Date of Study Completion (India) 17/04/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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 population3-5. 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 DM5, 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.  

 
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