| 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
|
|
|
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
|
|
|
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 |