National Institute for Health and Care Research Global Health Research Centre for Multiple Long-Term Conditions
NIHR-GHRC MLTC
1 other identifier
interventional
3,600
2 countries
120
Brief Summary
Multiple Long-Term Conditions (MLTC), defined as the coexistence of two or more chronic conditions, is increasingly prevalent in India. Despite this, the healthcare system remains largely focused on single-disease management, underscoring the urgent need for integrated, patient-centred approaches that are context-specific, equitable, and resource-sensitive. India's public health infrastructure is undergoing significant reform through the Ayushman Bharat Yojana, which aims to upgrade 150,000 sub-centres and primary health centres into Health and Wellness Centres (HWCs). These centres are designed to provide comprehensive care including prevention, treatment, and rehabilitation to underserved populations. This transformation presents a strategic opportunity to embed multi-morbidity care into the evolving system, supported by the establishment of a Global Health Research Centre dedicated to MLTC. The NIHR Global Health Research Centre for Multiple Long-Term Conditions aims to transform the health system in India and Nepal by improving care for individuals living with MLTC. With chronic conditions on the rise due to epidemiological transitions, particularly among adults aged ≥40, there is an urgent need for integrated, people-centred care models. This project is being implemented in Anakapalli district (Andhra Pradesh), Jodhpur (Rajasthan), Sonipat (Haryana) and Nepal, encompassing both rural and urban contexts. The study is conducted among adult patients with MLTCs attending rural primary providers (Medical officers and Staff Nurse) delivering services at these facilities in India and Nepal. The intervention comprises an electronic decision support system (EDSS) to facilitate evidence-based clinical decision-making, assisted telemedicine model to enable timely specialist consultations, and a patient-facing mobile application-supported by community champions and care coordinators to enhance care coordination, self-management, and treatment adherence. At this stage, we have completed the case-mix and health facility assessments, alongside the in-depth interviews to identify challenges faced by patients, caregivers, and health care providers. Currently, we are pilot testing the health intervention in 4 PHCs in India and 2 PHCs in Nepal among 180 participants (30 participants per site). Findings from this pilot will inform refinement of the intervention, study tools, and implementation strategies, and will provide critical evidence on contextual adaptability to support the design of a subsequent cluster randomized controlled trial (RCT). In the full RCT, we will evaluate the effectiveness of a health system intervention comprising an electronic clinical decision support system, assisted telemedicine, a patient-facing application, and community champions. The study will be conducted across selected sites in India and Nepal using a cluster randomized controlled design, in which Primary Health Centres (PHCs) are allocated to either the intervention or usual care arm. The intervention includes structured clinical workflows, a digital decision support system, assisted telemedicine, and patient-facing mobile health tools to strengthen continuity and coordination of care. Participants will engage with these components over a six-month implementation period. Data collection will include participant surveys and qualitative interviews, complemented by routine supervision checklists and system usage analytics to assess implementation processes and usability. The study findings will generate robust evidence to inform scalable and context-appropriate models of integrated care for multiple long-term conditions (MLTCs) in primary care settings in low- and middle-income countries. By embedding digital tools and strengthening PHC systems, the intervention aims to improve quality of life, reduce fragmentation of care, and establish a sustainable model for MLTC management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2026
CompletedStudy Start
First participant enrolled
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2028
May 12, 2026
May 1, 2026
3 months
April 25, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-Related Quality of Life (EQ-5D VAS)
Mean change in health-related quality of life measured using the EuroQol Five-Dimension Visual Analogue Scale (EQ-5D VAS). Scale Range: 0 to 100, Interpretation: Higher scores indicate better health status. Unit of Measure: Score on a 0-100 scale
Health-related quality outcome will be assessed at baseline (recruitment) and at 24 months (endline).
Secondary Outcomes (20)
Systolic Blood Pressure (SBP)
Systolic Blood Pressure outcome will be assessed at baseline (recruitment) and at 24 months (endline).
Diastolic Blood Pressure (DBP)
Change in the diastolic blood pressure from baseline to 24-month endline.
Glycated Haemoglobin (HbA1c)
HbA1C outcomes will be assessed at baseline (recruitment) and at 24 months (endline)
Fasting Plasma Glucose
Glycaemic control outcomes will be assessed at baseline (recruitment) and at 24 months (endline).
Total cholesterol
Total cholesterol outcome will be assessed at baseline (recruitment) and at 24 months (endline).
- +15 more secondary outcomes
Study Arms (2)
Intervention arm
EXPERIMENTALCare delivery will be supported by a codesigned integrated intervention package comprising an electronic decision support system (EDSS) embedded within clinical consultations, assisted telemedicine enabling specialist input and a patient-facing mobile application designed to support self-management. Healthcare providers will use the decision support platform during consultations to generate structured treatment plans, which may be modified based on clinical judgement. Telemedicine consultations will be initiated when specialist input is required, and patients will receive digital reminders and educational support through the patient-facing mobile application.
Control arm
NO INTERVENTIONThe arm includes patients with multiple long-term conditions (MLTCs) who receive routine standard care at Primary Health Centres (PHCs) as per existing public health system practices, without any additional intervention components.
Interventions
Algorithms were developed for hypertension, diabetes, mental health conditions, respiratory diseases, backache, substance use, and vision and hearing problems. Researchers reviewed national and LMIC guidelines and created flowcharts covering the full care pathway from screening and tests to diagnosis, treatment, referral, and follow-up. After multiple expert reviews, the final flowcharts were converted into structured datasets and workflow variables, forming the basis of the EDSS, which guides health workers step by step in delivering consistent care
Assisted telemedicine enables participants to access teleconsultations with support from health staff through a facility-based model, where patients visit PHCs and connect with remote specialist doctors via telemedicine hubs.
The patient-facing app enables participants to track key health indicators, receive medication and appointment reminders, and access educational content. Community champions help to develop patient networks to improve disease management and empower them in their self-care.
Eligibility Criteria
You may qualify if:
- Adults aged 40 years or above
- Attending the Primary Health Centre (PHC) during the enrollment period
- Diagnosed with two or more of the following chronic conditions:
- Hypertension
- Diabetes mellitus
- Depression
- Anxiety
- Chronic obstructive pulmonary disease (COPD)
- Asthma
- Vision impairment
- Hearing impairment
- Osteoarthritis
- Chronic back pain
You may not qualify if:
- Age \< 40 years
- Presence of only one or none of the listed chronic conditions
- Pregnant or breastfeeding women
- Severe cognitive impairment or dementia that prevents informed consent or or reliable participation
- Bedridden or terminally ill individuals with a life expectancy \< 6 month
- Current participation in another clinical or interventional research study may interfere with study outcomes
- Severe psychiatric illness (e.g., psychosis or bipolar disorder) other than depression or anxiety
- Unable or unwilling to provide written informed consent
- Severe communication barriers that prevent participation in interviews or questionnaires, even with assistance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre for Chronic Disease Control, Indialead
- University of Leicestercollaborator
- All India Institute of Medical Sciences, Jodhpurcollaborator
- Kathmandu Medical College and Teaching Hospitalcollaborator
Study Sites (120)
Atchuthapuram Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Buchhayyapeta Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Burugupalem Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Butchimpeta Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Cheedikada Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Chowduwada Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Chuchukonda Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Devarapalli Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Dimili Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Gavaravaram Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Golugonda Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Gullepalli Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Gunupudi Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Haripalem Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
K D Peta Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Kasimkota Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
L V Palem Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Mangavaram Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Pedagogada Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Penugollu Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Ravikamatham Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Sabbavaram Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
THAGARAMPUDI Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Thallapalem Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Thurakalapudi Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Vada Cheepurupalli Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Vaddadi Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Vechalam Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
Vemulapudi Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 530001, India
KJ Puram Primary Health Care Center, Narsīpatnam, Anakapalli 531115
Visakhapatnam, Andhra Pradesh, 531115, India
Ahulana, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Badkhalsa, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Banwasa, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Baroda Mor, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Bega, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Bhatgaon, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Bidhlana, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Bidhlana, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Butana, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Butana-zafrabad, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Dhatoli, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Dubeta, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Farmana, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Ferozpur-banger , Rural primary health care centre
Sonīpat, Haryana, 131101, India
Ganaur, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Jagsi, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Jakhauli, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Juan, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Khanda, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Khanpur- kalan , Rural primary health care centre
Sonīpat, Haryana, 131101, India
Kharkhoda, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Kundli, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Mahra, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Mohana, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Mundlana, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Murthal, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Nahari, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Purkhas, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Rukhi, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Sargathal Shamri, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Sisana, Rural primary health care centre
Sonīpat, Haryana, 131101, India
Artiya kalla, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Bala, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Bhatinda, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Bhavi, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Binawas, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Binjwariya, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Bisalpur
Phalodi, Jodupur, 342801, India
Dangiyawas, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Danwara Primary Health Care Center
Phalodi, Jodupur, 342801, India
Dhadhniya Bhayla, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Dhanari Kalla, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Gangani, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Guda vishnoiya, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Hariyadhana, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Jalupura, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Jhalamand, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Khangta, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Khawaspura, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Kherapa, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Koshana, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Narwa, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Pandit Ji Ki Dhani , Primary Health Care Center
Phalodi, Jodupur, 342801, India
Pooniyo Ki Pyau, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Salwa Kallan, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Salwa Khurad, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Satlana, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Sointra, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Soyla, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Tilwasani, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Bhandara Hospital
Bharatpur, Bagmati, 44200, Nepal
Ichchhakamana Basic Hospital
Bharatpur, Bagmati, 44200, Nepal
Kalika Municipal Hospital
Bharatpur, Bagmati, 44200, Nepal
Khairahani Municipal Hospital
Bharatpur, Bagmati, 44200, Nepal
Shivnagar PHC
Bharatpur, Bagmati, 44200, Nepal
Bakaiya Municipal Hospital
Bharatpur, Bagmati, 45206, Nepal
Bhimphedi PHC
Bharatpur, Bagmati, 45206, Nepal
Manahari Municipal Hospital
Bharatpur, Bagmati, 45206, Nepal
Padampokhari Municipal Hospital
Bharatpur, Bagmati, 45206, Nepal
Palung PHC
Bharatpur, Bagmati, 45206, Nepal
Bishnudevi hospital
Kathmandu, Bagmati, 1244600, Nepal
Dakshinkali Nagar Hospital
Kathmandu, Bagmati, 1244600, Nepal
Nagarjung Municipal hospital
Kathmandu, Bagmati, 1244600, Nepal
Sangla PHC
Kathmandu, Bagmati, 1244600, Nepal
Banepa Municipal hospital
Kavre, Bagmati, 45206, Nepal
Bhumlu Basic Hospital
Kavre, Bagmati, 45206, Nepal
Dhulikhel PHC
Kavre, Bagmati, 45206, Nepal
Dhuseni Siwalaya Primary Hospital
Kavre, Bagmati, 45206, Nepal
Mandandeupur Basic Hospital
Kavre, Bagmati, 45206, Nepal
Panauti Municipal Hospital
Kavre, Bagmati, 45206, Nepal
Panchkhal Municipal Hospital
Kavre, Bagmati, 45206, Nepal
Sunthan PHC
Kavre, Bagmati, 45206, Nepal
Badegau PHC
Lalitpur, Bagmati, 45206, Nepal
Lele PHC
Lalitpur, Bagmati, 45206, Nepal
Lubhu PHC
Lalitpur, Bagmati, 45206, Nepal
Thansingtar Hospital
Lalitpur, Bagmati, 45206, Nepal
Deurali PHC
Nuwākot, Bagmati, 45206, Nepal
Kakani PHC
Nuwākot, Bagmati, 45206, Nepal
Kharanitar PHC
Nuwākot, Bagmati, 45206, Nepal
Nuwakot
Nuwākot, Bagmati, 45206, Nepal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prabhakaran Dorairaj, MD, DM
Center for Chronic Disease Control
- PRINCIPAL INVESTIGATOR
Kamlesh Khunti, MD, DM
University of Leicester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- During recruitment and baseline assessment, data collectors are unaware of future allocation, as randomization occurs only after completion of recruitment. This ensures that baseline data collection is conducted without knowledge of group assignment. Randomization is performed at the cluster (Primary Health Centre) level, with allocation concealment maintained during the process to prevent selection bias. Following allocation, the study is open-label, and participants as well as providers are aware of their assigned group. However, outcome assessment relies on standardized tools and objective measurements, and data analysis may be conducted by analysts blinded to allocation, where feasible. No additional parties beyond those described above are masked in this trial.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor & Executive Director
Study Record Dates
First Submitted
April 25, 2026
First Posted
May 12, 2026
Study Start
May 5, 2026
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
August 30, 2028
Last Updated
May 12, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 01-09-2026 till 30-12-2027
- Access Criteria
- Only bonafide researchers with a valid research question shall be provided data. Interested researchers shall write to Prof. Prabhakaran (dprabhakaran@ccdcindia.org) with a concept note and necessary approvals as applicable.
All data shared for the purposes of analysis and dissemination will be fully de-identified prior to transfer. Personal identifiers, including names, addresses, and contact information, will be removed from the dataset and replaced with a unique participant identification (PID) code. This process will ensure that individual participants cannot be directly or indirectly identified. The de-identified dataset will be used solely for research and analytical purposes, and all data handling procedures will adhere to applicable ethical guidelines and data protection standards to ensure confidentiality and privacy of participants.