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CTRI Number  CTRI/2024/02/062988 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 15/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Improving lung health care in government health system 
Scientific Title of Study   Enhancing Chronic Respiratory disease care through upskilling health care providers of the government health system in a rural district in India: a pre-post educational intervention trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Biswajit Paul 
Designation  Professor  
Affiliation  Christian Medical College Vellore 
Address  Room no. 1, HOD Office, RUHSA Department Community Health Division Christian Medical College Vellore

Vellore
TAMIL NADU
632209
India 
Phone  8300031301  
Fax    
Email  drbpaul@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Biswajit Paul 
Designation  Professor  
Affiliation  Christian Medical College Vellore 
Address  Room No.1, HOD Office RUHSA Department Division of Community Health Christian Medical College Vellore

Vellore
TAMIL NADU
632209
India 
Phone  8300031301  
Fax    
Email  drbpaul@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Paul Jebaraj 
Designation  Training Officer 
Affiliation  Christian Medical College Vellore 
Address  Room no. 18, Training Unit RUHSA Department Division of Community Health Christian Medical College Vellore

Vellore
TAMIL NADU
632209
India 
Phone  9629042504  
Fax    
Email  paul.jebaraj@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
National Institute for Health and Care Research (NIHR) UK 
 
Primary Sponsor  
Name  National Institute for Health and Care Research NIHR UK 
Address  RESPIRE NIHR Global Health Research Unit on Respiratory Health Usher Institute, University of Edinburgh, Old Medical School, Doorway 3, Teviot Place, Edinburgh EH8 9AG 
Type of Sponsor  Other [UK Government Funding Agency] 
 
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 Biswajit Paul  Government Primary Health Centres in Tirupathur district (Madhanur and Alangayam blocks)  Deputy Director of Health Services, Tirupathur District, Government of Tamil Nadu.
Vellore
TAMIL NADU 
8124034755

drbpaul@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Health Ministry Screening Committee (HMSC) Department of Health Research   Approved 
INSTITUTIONAL REVIEW BOARD CMC VELLORE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Chronic respiratory disease care in government health system 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational Intervention  The intervention includes education on respiratory health to create awareness, capacity building of the health facility and skills training of health providers to diagnose, treat and follow up chronic respiratory disease patients.  
Comparator Agent  Knowledge, attitude and practice of health providers before the intervention  The baseline knowledge, attitude and practice of health providers before the intervention will be compared after the intervention period to measure the difference. The health providers before intervention act as comparators.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthcare providers involved in education screening or management of chronic respiratory disease patients in primary health care setup 
 
ExclusionCriteria 
Details  healthcare providers who do not consent to take part 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in knowledge attitude and practice of health providers of PHCs towards CRD management including screening and follow-up  At Baseline and after intervention period of 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in health system to CRD care (assessed using WHO Harmonized Health Facility Assessment)
2. Patient experience of CRD care (assessed using adapted British Lung Foundation COPD Patient Passport Responses)
3. The incremental increase in the no. diagnosed with CRD over six months
4. Increased compliance to treatment (assessed using test of adherence to inhalers (TAI) by providers at 3, 6, 9 and 12 months 
Outcome 1: At Baseline and after intervention
Outcome 2: At Baseline and at 3, 6, 9 and 13 months
Outcome 3: At baseline, 6 and 12 months of intervention
Outcome 4: 3, 6, 9 and 12 months 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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 2 
Date of First Enrollment (India)   24/03/2024 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included http:datashare.is.ed.ac.uk).

  6. For how long will this data be available start date provided 31-08-2025 and end date provided 01-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - De-identification data will be shared with University of Edinburgh data repository - data SHARE.
Brief Summary  

Chronic respiratory diseases (CRDs) are a global health problem with low- and middle-income countries contributing about 90% of global DALYs and deaths - and India alone contributing approximately one-third of cases, suggesting a high CRD burden and unmet health need. CRDs in low resource settings are neglected, and often poorly diagnosed, leading to missed opportunities for early initiation of treatment, and poor patient pathways. While CRDs are not curable, they can be treated effectively using evidence-based protocols for diagnosis and treatment to control symptoms and improve quality of life. The government health system, with its three-tier healthcare and state/country wide network is in a unique position to provide a solution to this problem, provided orientation and training are made available to health care providers and evidence-based guidelines are followed. The aim of this research project is capacity building, targeting government primary health centres in Tirupathur district (Madhanur  and Alangayam blocks) through alignment to evidence based CRD management achieved by education, training and skill development to change CRD health care through improvement of knowledge, attitudes and practice. The study will be conducted using a one-group pre-test/post-test, quasi-experimental study design. A needs assessment will be conducted using a tool developed by the investigators (WHO Harmonised Health Facility Assessment, interviews, and review of reports and registers) to assess the gaps in facility and resources and the KAP of the providers; further, there will be exit interviews among patients. Tailored training sessions for doctors, community health workers and therapists on management of CRDs will be provided to orient them to evidence-based diagnosis and management of CRDs including health education, follow-up and referral.  Weekly review meetings will be held as a part of monitoring and evaluation to assess the progress of patient education, screening, clinical review and follow-up. The outputs that will be measured are numbers of training sessions, awareness programmes, screenings done, protocol-based clinical reviews done, spirometry investigations, chest x-rays done and patients diagnosed and treated. Improvement in CRD care in the government health system will be identified using the WHO Harmonized Health Facility Assessment combined core questionnaire tool for CRD. Perceived experience of CRD care by patients will be assessed with the adapted British Lung Foundation COPD Patient Passport responses. Improvement in KAP related to CRD care among providers will be assessed by pre- and post- KAP surveys. Increased compliance to treatment will be assessed using TAI by providers at 3, 6, 9 and 12 months; improvement in KAP of providers will also be assessed at the end of the intervention period. This educational intervention will help in improving the quality of CRD care at primary healthcare level in Government health system using existing manpower through capacity building and skills training.

 
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