| CTRI Number |
CTRI/2026/02/104254 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Improving Quality of Life of People with Tuberculosis Through Community-Based Nursing Care in Selected Areas. |
|
Scientific Title of Study
|
Effectiveness of a Community-Based Nursing Interventions on Quality of Life Among Tuberculosis Clients in Selected Rural Areas, Andhra Pradesh. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pusarla Prasanthi |
| Designation |
Vice principal |
| Affiliation |
Vims Mother Theresa College Of Nursing |
| Address |
Vims mother Theresa college of nursing
D D nagar
ground floor,department of community health nursing ground floor
Sundar nagar
Durga Puram
Vijayawada Krishna district
520003
KLEF Deemed to be University,
Green Fields, Vaddeswaram,
Guntur District, A.P., INDIA.
Pincode : 522 302.
Phone : 08645 - 350200
Krishna
ANDHRA PRADESH
520003
India |
| Phone |
9248521142 |
| Fax |
|
| Email |
chlprasanthi5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghava Prasad |
| Designation |
Professor |
| Affiliation |
KL University |
| Address |
KLEF Deemed to be University,
Department of ECE,Fourth floor,room no. L409
Green Fields, Vaddeswaram,
Guntur District, A.P., INDIA.
Pincode : 522 302.
Phone : 08645 - 350200
Guntur
ANDHRA PRADESH
522302
India |
| Phone |
9292251599 |
| Fax |
|
| Email |
chrp@kluniversity.in |
|
Details of Contact Person
Public Query
|
| Name |
Pusarla Prasanthi |
| Designation |
Vice Principal |
| Affiliation |
Vims Mother Theresa College Of Nursing |
| Address |
Vims mother Theresa college of nursing
D D nagar
ground floor,department of community health nursing ground floor
Sundar nagar
Durga Puram
Vijayawada Krishna district
520003
Krishna
ANDHRA PRADESH
520003
India |
| Phone |
9248521142 |
| Fax |
|
| Email |
chlprasanthi5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana College of Nursing, Chinthareddypalem,Nellore, Andhra Pradesh-524003,Nellore,Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Self funded Project |
| Address |
Narayana College of NursingChinthareddy Palem, Trunk Road, Nellore - 524001, Andhra Pradesh,India |
| Type of Sponsor |
Other [self funde project] |
|
|
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 |
| DrBVanaja kumari |
Selected Rural Areas,Nellore |
Narayan Nursing College,
Chinthareddy Palem,Nellore,Andhra pradesh,524003 India
Nellore
ANDHRA PRADESH |
9490894253
bnreddy290@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narayana College of Nursing |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community Based Nursing Interventions |
Breathing Exercise, Nutrition Health Education, Adherence Therapy, Behavioral Change Communication.TWO -SIX MONTHS Duratuion Frequency Every one week. |
| Comparator Agent |
Placebo |
Only one hour awareness on Improve Quality of Life. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
A. Willing and likely to adhere to treatment follow up.
B. Home address accessible for visiting and intending to remain within the area for follow up
C. Who are willing to participate in the study?
D. Who diagnosed as a active tuberculosis?
E. The participants who knows local language |
|
| ExclusionCriteria |
| Details |
A. Any known contraindication to taking anti tb drugs.
B. Severely ill tuberculosis patients.
C. Pregnancy and postnatal mothers
D. Patients who are having comorbidity.
E. Who are not willing to participate in the study?
F. Non-compliance with regime
G. Who are not available at the time of the study?
H. Obesity patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changing dietary habits and Promoting positive health behaviour and Encouraging and promoting physical activity, Adherence therapy |
Six Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce Mortality Rate |
4 Years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2028 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Community-Based Nursing Interventions
| Breathing Exercises | Deep Breathing Exercises | | Encouraging and Promoting Physical Activity | | Nutirtion Health Education | Change in Dietary Habits | | To Provide Guidence Nutritional Assesment and Counselling of Clients with Active Tuberculosis | | To Provide Guidence on Management of Under Nutrition in Clients with Active Tuberculosis. | | Adherence Therapy | Improve Medication compliance, Reduce Missed Dosage Enhance Treatment Completion. | | Method - Remainder Systems, Pill Organizers, Mobile Alerts, Care Giver Involvment. | | Behaviour Change Communication | Behaviour to be changed such as Medication Adherence, Lifestyle Modification, Social Sigma, Myth Correction. | | Method - Group Sessions, Audio Visual Aids, Digital Messaging. |
|