| CTRI Number |
CTRI/2020/01/022907 [Registered on: 22/01/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare health related information in hospitals and among patients in coastal Karnataka |
|
Scientific Title of Study
|
A cross sectional study to determine the organizational health literacy and patient health literacy in coastal Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramya Hari Thayyullathil |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
c/o Room number 25
MHA coordinator
Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
ramyaharidxb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Usha Rani |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Hospital Administration
Prasanna School of Public Health
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
usha.rani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Usha Rani |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Hospital Administration
Prasanna School of Public Health
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
usha.rani@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dr TMA Pai Hospital , Udupi, Karnataka 576101 |
| Kasturba Medical College, Manipal ,Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Ramya Hari Thayyullathil |
| Address |
Prasanna School of Public Health,Department Of Hospital Administration,Manipal Academy of Higher Education,Manipal -576104 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramya Hari Thayyulathil |
Dr TMA Pai Hospital |
Department of General Medicine
Udupi, Karnataka-576101
Udupi
KARNATAKA |
7676415439
ramyaharidxb@gmail.com |
| Dr Ramya Hari Thayyulathil |
Kasturba Medical College |
Department of General Medicine
Kasturba Medical College
Manipal
Udupi
KARNATAKA |
7676415439
ramyaharidxb@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
IPD discharge patients who are mentally and physically stable. |
|
| ExclusionCriteria |
| Details |
Unwilling patients and patients who are mentally and physically unstable. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in the level of organizational health literacy and health literacy among patients in a tertiary care hospital and a private hospital.
Relationship between level of patient education and health literacy. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "270"
Final Enrollment numbers achieved (India)="270" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/01/2020 |
| Date of Study Completion (India) |
01/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1 Ö. Örsal, P. Duru, Ö. Örsal, K. Tırpan, and A. Çulhacı, “Analysis of the relationship among
health awareness and health literacy, patient satisfaction levels with primary care in patients
admitting to primary care health centers,†Patient Educ. Couns., vol. 102, no. 2, pp. 376–382,
2019.
2 U. P. Rathnakar, M. Belman, A. Kamath, B. Unnikrishnan, K. Ashok Shenoy, and A. L. Udupa,
“Evaluation of health literacy status among patients in a tertiary care hospital in coastal
Karnataka, India,†J. Clin. Diagnostic Res., vol. 7, no. 11, pp. 2551–2554, 2013.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Health literacy is defined as the ability to obtain,process and understand basic health information and services needed to make appropriate health decisions and follow instructions for treatment. Organizational health literacy is defined as the ability of organizations to provide services and information that are easy for patients to find ,understand and use to help patients make decisions and to remove existing barriers. This study is focused to assess the gap between organizational health literacy and patient health literacy in a tertiary care hospital and private hospital .
|