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
|
|
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
|
|
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. |