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CTRI Number  CTRI/2025/01/079434 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Family support health education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How Family Support and Health Education can Enhance Quality of Life for Pulmonary Tuberculosis patients in Puducherry-Randomized Control Trial 
Scientific Title of Study   Effectiveness of Family Support Health Education Intervention to improve Health -Related Quality of Life among Drug Sensitive Pulmonary Tuberculosis patients in Puducherry-Randomized Control 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. Anithadevi K 
Designation  Post Graduate 
Affiliation  SRI LAKSHMI NARAYANA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Community Medicine, Sri Lakshmi Narayana Institute of Medical Sciences, Ossudu, Agaram Village, Villianur Commune,Koodapakkam post

Pondicherry
PONDICHERRY
605502
India 
Phone  7092201601  
Fax    
Email  anithadevi023@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Kannan K 
Designation  Professor 
Affiliation  SRI LAKSHMI NARAYANA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Community Medicine, Sri Lakshmi Narayana Institute of Medical Sciences,Ossudu,Agaram village,Villianur Commune, Koodapakkam post

Pondicherry
PONDICHERRY
605502
India 
Phone  9786028602  
Fax    
Email  drkannan83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Anithadevi K 
Designation  Post Graduate 
Affiliation  SRI LAKSHMI NARAYANA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Community Medicine,Sri Lakshmi Narayana Institute of Medical Sciences,Ossudu, Agaram Village, Villianur Commune, Koodapakkam Post

Pondicherry
PONDICHERRY
605502
India 
Phone  7092201601  
Fax    
Email  anithadevi023@gmail.com  
 
Source of Monetary or Material Support  
Department of Community Medicine,Sri Lakshmi Institute of medical science,Ossudu,Agaram village, Villianur Commune,Koodapakkam post, Puducherry 605502 
 
Primary Sponsor  
Name  Sri lakshmi narayana institute of medical sciences 
Address  Osudu, Agaram village, Villianur commune, Kudapakkam post, Puducherry 605502 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Anithadevi K  Sri Lakshmi Narayana Institute of Medical Sciences  Department of Community Medicine, Sri Lakshmi Narayana Institute of Medical Sciences,Ossudu, Agaram Village, Villianur Commune, Koodapakkam post
Pondicherry
PONDICHERRY 
7092201601

anithadevi023@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z201||Contact with and (suspected) exposure to tuberculosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conservative management  no family support health education for period of 6 months 
Intervention  Modified Family Support health education intervention  Family support health education Intervention to improve health related quality of life among drug sensitive pulmonary tuberculosis for patients in puducherry for the period of 6 months 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All newly diagnosed drug sensitive adult Pulmonary TB cases in the year of 2024 registered under NTEP, Puducherry irrespective of gender, receiving treatment from the selected PHCs
2. Patients of age more than 18 years.
3. Participants staying with family members (spouse, children, siblings, parents).
 
 
ExclusionCriteria 
Details  1. Patients too ill to participate, and the cases of retreatment Pulmonary Tuberculosis.
2. Participants with other comorbid illness including HIV infection, diabetes and other chronic diseases.
3. Family member of the Pulmonary Tuberculosis who has been already recruited into this study.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Modified FASTEN will improve health related Quality of Life among newly diagnosed drug sensitive Pulmonary tuberculosis  Baseline 2 months to 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Modified FASTEN intervention will also have positive impact on treatment outcome  6 months to 1 year 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
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 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="6"
Months="0"
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  


Topic: Effectiveness of Family Support Health Education Intervention to improve Health Related Quality of Life among Drug Sensitive Pulmonary Tuberculosis patients in Puducherry- Randomized control trial.

Supervisor name: Dr. K. Kannan

                             Professor

                      

 Abstract

Introduction: Tuberculosis (TB) is a major killer and cause of human suffering worldwide and imposes a substantial reduction in patients Health- Related Quality of Life .

      Health- Related Quality of Life indicates the consciousness of patients regarding their physical and mental health.

Its is, therefore, very relevant in comprehending and measuring the exact impact of the disease    state.

 

Aim: To study the impact of modified Family Support Health Education (FASTEN) in Health Related Quality of Life among newly diagnosed Drug Sensitive Pulmonary Tuberculosis patients.

      Objectives:

 

Primary Objective

      To determine the effectiveness of a modified Family Support     Health Education (FASTEN) intervention in improving the Health Related Quality of Life among newly diagnosed drug sensitive adult Pulmonary Tuberculosis patients in Puducherry.

 

      

Secondary Objective

       To compare the treatment outcome between the intervention and control group.

          

Materials and Methods:

Project design: A single-blinded, Randomized controlled field trial.

Project Setting: Field practice area of selected Primary Health Centres in Puducherry.

Target population: Newly diagnosed drug sensitive adult pulmonary Tuberculosis cases registered under National Tuberculosis Elimination Programme Puducherry district in year of 2024.

Sample size: 136

Data collection: Section-A: Socio-Demographic / economic factors questionnaire

This form collects basic details of patients such as age, sex,   race, religion, residence, occupation, education level, total family members, family income, marital status, smoking status and alcohol status.

             Section-B: SF 36 Questionnaire to assess Health Related Quality of Life.

This part consists of eight Health Related Quality of Life domains            

                                               i.     Physical Functioning ,

                                             ii.     Role limitation due to Physical condition ,

                                           iii.     Bodily Pain ,

                                            iv.     General Health ,

                                             v.     Vitality ,

                                            vi.     Social Functioning ,

                                          vii.     Role limitation due to personal Emotional problem ,

                                        viii.     General Mental Health .

 

Data analysis: Data will be entered in MS excel sheet. Analysis will be done using SPSS software version 16.Student T test/ Mann -Whitney test will be applied based on the distribution of the data. p value<0.05 will be taken as statistically significant.

Expected outcome: 1. Modified FASTEN will improve health related Quality of Life  among newly diagnosed drug sensitive Pulmonary tuberculosis.

                                  2. Modified FASTEN intervention will also have positive impact on treatment outcome

 

 

 

 

 

 

 
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