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Active Not Recruiting NCT07582380

Integrated Digital Health System With Electronic Decision Support, Assisted Telemedicine and MHeAlth-Supported Self-ManaGement to Improve Health-Related Quality of Life Among Adults With Multiple Long-Term Conditions in Primary Health Centres in India and Nepal: A Cluster Randomised Controlled Trial

Conditions: Chronic Conditions, Multiple, Diseases of the Circulatory System, Diseases of the Respiratory System, Endocrine, Nutritional and Metabolic Diseases, Mental, Behavioral and Neurodevelopmental Disorders, Diseases of the Musculoskeletal System and Connective Tissue, Diseases of the Ear and Mastoid Process, Diseases of the Eye and Adnexa

Sex: All
Ages: 40 Years – 100 Years
Healthy volunteers: No
Phase: NA
Enrollment: 3600
Sponsor: Centre for Chronic Disease Control, India

Location: Atchuthapuram Primary Health Care Center, Narsīpatnam, Anakapalli 531115 Visakhapatnam Andhra Pradesh

Summary

Many people in India and Nepal live with two or more long-term health conditions at the same time for example, high blood pressure together with diabetes, and often alongside problems such as joint pain, breathing difficulties, or anxiety. Living with several conditions at once is known as having multiple long-term conditions, or MLTC. Care for these conditions is usually provided one disease at a time, through separate clinics and services. This can mean repeated visits, several different doctors, many medicines to manage, and advice that does not always fit together. For participants and their families, this makes care harder, more time-consuming, and more expensive. This study tests a more joined-up way of caring for people with MLTC and examines whether it works better than usual care. Before designing the new approach, the investigators worked to understand the problem. The investigators examined existing health data, identified which conditions most commonly occur together, visited primary health centres to assess how ready they were to provide care and what were common conditions reported at these facilities and spoke with patients, families, and health care providers about the difficulties they face. The investigators then worked together with these groups to design the new model of care, so that it reflects real needs and fits local conditions. The new approach or intervention has three main components. The first is an electronic decision support system a computer tool that helps doctors and nurses assess a participant's conditions together and choose evidence-based treatment, rather than managing each condition separately. The second is an assisted-telemedicine service, which lets participants connect with a specialist by video from their local health centre, so expert advice is available without travelling long distances. The third is a mobile phone application for participants that offers simple health information, medicine and appointment reminders, and support for day-to-day self-care, available in local languages and in audio and video form for those who find reading difficult. Supporting all of this are trained care coordinators, called Care Mitras, who guide participants through their care, help them use the tools, and encourage regular follow-up. The study takes place in both rural and urban areas: Anakapalli District in Andhra Pradesh, Jodhpur in Rajasthan, and Sonipat in Haryana in India, and Lalitpur , Kathmandu , Bhaktapur , Kavre , Chitwan , Makwanpur , Nuwakot Districts, at Bagmati province in Nepal. Adults aged 40 years and over who have two or more long-term chronic conditions can take part. The study uses a cluster randomised controlled trial design. This means whole primary health centres not individual participants were assigned to one of two groups. Health centres in the first group provide the new model of care, while those in the second group continue with usual care. Comparing the two groups shows whether the new approach works better. In total, 120 health centres took part, and 3,600 participants were enrolled across them. The main question the investigators want to answer is whether the new approach improves participants' quality of life (how they feel and function in daily life). The investigators will also examine other important outcomes. Information is collected through health check-ups and interviews with participants over the course of the study, along with records of how the tools are used in practice. By bringing together digital tools, specialist access, and local support within primary care, the study aims to show whether this integrated, people-centred approach can improve life for people with MLTC and reduce the gaps in their care. If it works, the findings can help build practical and lasting ways to care for people with multiple conditions in India, Nepal, and other countries with similar health systems.

Eligibility Criteria

Inclusion Criteria: * 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: 1. Hypertension 2. Diabetes mellitus 3. Depression 4. Anxiety 5. Chronic obstructive pulmonary disease (COPD) 6. Asthma 7. Vision impairment 8. Hearing impairment 9. Knee Osteoarthritis 10. Chronic back pain Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07582380). StuddyBuddy aggregates publicly available trial information.