| CTRI Number |
CTRI/2024/07/070456 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Health-related quality of life and problems faced among Thalassemia patients |
|
Scientific Title of Study
|
A cross-sectional study to assess the health-related quality of life and problems faced among Thalassemia patients in selected hospitals of Udupi District, Karnataka. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Helan Anna Joseph |
| Designation |
Under graduate student |
| Affiliation |
Manipal College of Nursing MCON Manipal Academy of Higher Education MAHE |
| Address |
room no 201
Department of Child Health Nursing
Manipal College of Nursing MCON Manipal Academy of Higher Education MAHE Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
08590829304 |
| Fax |
|
| Email |
helan.joseph@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu Margaret E |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal College of Nursing (MCON), Manipal Academy of higher education,MAHE |
| Address |
Department of Child Health Nursing 2nd floor Manipal College of Nursing MCON Manipal Academy of Higher Education MAHE Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Janet Prameela DSouza |
| Designation |
Assistant Professor |
| Affiliation |
Manipal college of Nursing, Manipal Academy of higher education MAHE |
| Address |
Department of Medical Surgical Nursing 1st floor Manipal College of Nursing MCON Manipal Academy of higher education MAHE Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9986417306 |
| Fax |
|
| Email |
janet.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Helan Anna Joseph |
| Address |
Manipal College of Nursing MCON Manipal Academy of higher Education MAHE Manipal Udupi Karnataka |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Ms Helan Anna Joseph |
Manipal College of Nursing, Manipal |
Department of Child Health Nursing, Manipal College of Nursing, Manipal
Udupi
KARNATAKA |
8590829304
helan.joseph@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D561||Beta thalassemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1. Thalassemia patients who are available during the data collection and willing to participate in the study.
2. Thalassemia patients who can speak and write English and Kannada. |
|
| ExclusionCriteria |
| Details |
Those who are not present at the time of the study.
Those who are below the age of 13 and above the age of 25. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life. |
On admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/07/2024 |
| 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="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
|
A cross-sectional study to assess the health-related quality of life and problems faced Among Thalassemia patients in selected hospitals of Udupi District, Karnataka. The purpose of study is to assess the health-related quality of life and problems faced by patients suffering from Thalassemia. The findings from the study will give a baseline information, which will help the health care professionals to take appropriate measures to improve the quality of their life and to reduce the magnitude of the problems faced by them. Aims & objectives:The objectives of the study are to:
· Assess the health-related quality of life of patient’s suffering from Thalassemia.
· Identify the problems faced by patient suffering from Thalassemia.
· Find the association between quality of life of thalassemia patients and selected variables like age, gender, education, occupation, parent’s education, parent’s occupation, socioeconomic status, number of siblings, family history, income.
|