| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included http:datashare.is.ed.ac.uk).
- 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.
- 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. |