FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090775 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [Implementation Research]  
Study Design  Single Arm Study 
Public Title of Study   Promoting Access for primary Care through Innovative Strategies in Chittoor 
Scientific Title of Study   Promoting Access and Care through Innovative Strategies in Chittoor (PROACTIVE CT), An Implementation Research 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dorothy Lall 
Designation  Assistant Professor, Community Health Department 
Affiliation  Christian Medical College,Vellore 
Address  Department of Community medicine, Christian medical college Vellore, Chittoor campus

Chittoor
ANDHRA PRADESH
517002
India 
Phone  9483604200  
Fax    
Email  dorothy.lall@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dorothy Lall 
Designation  Assistant Professor, Community Health Department 
Affiliation  Christian Medical College,Vellore 
Address  Department of Community medicine, Christian medical college Vellore, Chittoor campus- 517002

Chittoor
ANDHRA PRADESH
517002
India 
Phone  9483604200  
Fax    
Email  dorothylall@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashwin S 
Designation  Assistant professor, community medicine, Christian medical college vellore 
Affiliation  Christian Medical College,Vellore 
Address  Community medicine department, Christian medical college Vellore, Chittoor campus

Chittoor
ANDHRA PRADESH
517002
India 
Phone  9840748004  
Fax    
Email  ashwin.s@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Gates Foundations (BMGF)- The Capital Court, 5th Floor, Olof Palme Marg, Munirka, New Delhi, India, Delhi 110067 
 
Primary Sponsor  
Name  Gates Foundations 
Address  Capital Court, 5th Floor, Olof Palme Marg, Munirka, New Delhi, Delhi 110067 
Type of Sponsor  Other [Charitable Trusts] 
 
Details of Secondary Sponsor  
Name  Address 
CMC Vellore CMCV mission network collaborative MNC research grant  Vellore, Tamil Nadu 
Vellore CMC foundation VCMCF  Vellore, Tamil Nadu 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashwin S  Gudipala Mandal, Christian medical college Chittoor   Department of community medicine, Chittoor campus, Christian Medical College, Vellore - Chittoor Rd, Valliappa Nagar, Kalagatur, Chittoor, Andhra Pradesh 517002
Chittoor
ANDHRA PRADESH 
9840748004

ashwinsukumar101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board IRB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z038||Encounter for observation for other suspected diseases and conditions ruled out,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  care coordination through telephone triaging in Gudipala Mandal   The interventions proposed are- 1. Care coordinators at a call enter to triage patients to an appropriate level of care, schedule appointments and enable follow-up and reminders that integrates with private and public health facilities in a mandal of Chittoor district. 2. A digital solution that enables appointment scheduling, follow up reminders and alerts to the facility at appropriate level of care 3. Follow up of persons in the community through community volunteers.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Any individual residing in Gudipala Mandal seeking health care  
 
ExclusionCriteria 
Details  Exclusion Criteria is only for the participants who are not willing to participate in the research 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Timeliness of care, 2. Appropriateness level of care, 3. Out of pocket expenditure, 4. Responsiveness of health system, 5. Clinical outcomes of care for chronic conditions (hypertension, diabetes, COPD and asthma control), 6. Patient satisfaction and 7. implementation outcomes of reach/ penetration, feasibility and acceptability and identify the barriers/ facilitators of implementation.

 
at base line enumeration will be done and after 1 year and at 2 years after intervention the outcomes will be assessed

 
 
Secondary Outcome  
Outcome  TimePoints 
prevalence of various disease in Gudipala mandal  at the baseline, t 1 year & at 2 years after intervention  
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   04/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This project aims to strengthen the delivery of primary health care and improve access to timely, quality health care for residents of Gudipala Mandal in Chittoor district (population of 50000 persons). Primary health care is the backbone of health service delivery and is envisaged to be the hub of integrated, coordinated care across levels of health care. Primary health care caters to 75% of basic health needs and focuses on prevention and health promotion. Improved primary health care access would result in improved health status, well controlled chronic conditions like diabetes and hypertension as well as improved responsiveness of the health system to people’s needs. 

The expected outcomes of this intervention can be measured before and after the interventions through a baseline and endline survey. There would be mixed methods approach to quantitatively assess health status as well as qualitatively assess the responsiveness of the health system to peoples needs. 

The project would seek to implement coordinated, continuous quality primary care for the people of Gudipala Mandal in Chittoor district. The main intervention of this project is the development and deployment of a care coordination hub and schedule appointments. The care coordination hub would include a team of care coordinators centrally located that are able to provide information and serve as a triage to direct people to appropriate level of care.  Depending on the persons need, the hub will be able to register patients for care at the most appropriate health facility ensuring prompt access to a health facility. The medical record of the visit would be saved in the same system for further follow up action by the care coordinators. The center will facilitate follow up and reminders for those that do not seek care or follow up care received or those with poorly controlled health conditions. 

While the community stands to benefit from this program, they are also a potential risk/challenge to the success of the project. The community acceptance of this care coordination program would be crucial to its success, and mitigation will be done through our engagement with the community. A series of meetings will be conducted with the community to involve them in the design and deployment process efforts will be made to inform the entire community about how this would function and the benefit they can expect. 

Another potential challenge is coordination between all the various facilities and ensuring completion of records by all stakeholders. Since the success of the project rests on the sufficiency of data and the availability of information, it would be important to ensure that all stakeholders, including doctors enter information onto the system. Capacity building workshops will be conducted with doctors as well as involve all stakeholders throughout the design and deployment phases. 

The portal and the services of the digital hub will be extended to the government run primary care facilities like the health and wellness center and the primary health center. This would be important to demonstrate the applicability of the technological solution across all primary health care facilities. The government will have to be involved and engaged early in the project even though extension would only happen later in the project. Efforts will be made to involve and inform the government throughout the design and implementation stages of this program.

In order that CMC Chittoor campus implement this project we will need to employ new staff- the care coordinators and community staff. Arrangements will be made for the space for the digital hub. We propose to locate this in the secondary hospital area to facilitate coordination of care for persons coming to the hospital or alternatively we could house this hub in a location close by to the hospital. We will need to introduce a digital health record at the primary care facilities and link it to the secondary level of care, this is currently done on paper manually. 

The project is sustainable and will contribute to enhancing the work currently undertaken through CMC Chittoor’s, community health department. The need for a digital solution that links primary to secondary care is a longstanding need and has application across all the primary outreach health care services of CMC. The findings on the deployment of this project will also be integrated with the Andhra Pradesh government to cater health care needs to its maximum potential to the people of the rural areas.

Abstract

In this study we aim to implement and evaluate an intervention package that includes deployment of care coordinators and a digital application that facilitates appointments and care coordination across health facilities to improve the access to reliable information, timely care and an appropriate level of care, Responsiveness of the health system, Clinical outcomes of care for chronic conditions (hypertension, diabetes, COPD and asthma control) and patient satisfaction.

Methods: We propose to use an implementation research approach and a before and after design to study the effectiveness of the intervention package to improve timely and appropriate care for persons living in Gudipala mandal. The interventions proposed are-

1. Care coordinators at a call enter to triage patients to an appropriate level of care, schedule appointments and enable follow-up and reminders that integrates with private and public health facilities in a mandal of Chittoor district.

2. A digital solution that enables appointment scheduling, follow up reminders and alerts to the facility at appropriate level of care

3. Follow up of persons in the community through community volunteers.

These interventions will be developed and implemented using participatory methods that include stakeholder mapping, co design and regular stakeholder engagement.

The effectiveness of the intervention will be measured quantitatively through a cross sectional survey at baseline and after 18 months of implementation.

1. Timeliness of care, 2. Appropriate level of care, 3. Out of pocket expenditure, 4. Responsiveness of the health system 5. Clinical outcomes of care for chronic conditions (hypertension, diabetes, COPD and asthma control) and Patient satisfaction

6. implementation outcomes of reach/ penetration, feasibility and acceptability

The study will be conducted in three phases

Phase 1 Baseline assessment and enrollment of the residents in Gudipala Mandal

Phase 2 Deployment of the call center and digital app for care coordination in Gudipala Mnadal

Phase 3 Outcome assessment at 18 months 


 
Close