| CTRI Number |
CTRI/2018/08/015268 [Registered on: 10/08/2018] Trial Registered Prospectively |
| Last Modified On: |
10/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of self reported physical symptoms, stress and anxiety social support, coping strategies among women carrier for hemophilia |
|
Scientific Title of Study
|
Assess the bio-psychosocial status (Physical symptoms, self-reported stress and anxiety and social support), coping strategies and lived experiences among women carrier for hemophilia: A mixed method approach. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sulochana Badagabettu |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
Manipal Academy of Higher Education
MAnipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844995784 |
| Fax |
|
| Email |
sulochana.k@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sulochana Badagabettu |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
Manipal Academy of Higher Education
MAnipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844995784 |
| Fax |
|
| Email |
sulochana.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sulochana Badagabettu |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
Manipal Academy of Higher Education
MAnipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844995784 |
| Fax |
|
| Email |
sulochana.k@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Hemophilia Society Manipal, Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Bayer Consumer Care AG |
| Address |
Bayer Consumer Care AG
Attn. Nicole Vogt
Peter Merian-Strasse 84
CH-4052 Basel
Switzerland,
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| sulochana |
Hemophilia Society, Kasturba Hospital, Manipal, |
Manipal College of Nursing
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9844995784
sulochana.k@manipal.edu |
|
|
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 |
| Healthy Human Volunteers |
Women Carrier for Hemophilia |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
56.00 Year(s) |
| Gender |
Female |
| Details |
Women carriers for hemophilia
Study participants who are willing to give consent
For qualitative approach, women who are having severe stress and anxiety and low coping, willing for audio recording
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient reported outcomes such as physical symptoms, stress and anxiety, coping and social support. |
one time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lived experience among women carrier for hemophilia. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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 1 |
|
Date of First Enrollment (India)
|
13/08/2018 |
| 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
|
Not yet data collection is not yet initiated. After IEC approval and CTRI registartion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Data will be collected after obtaining informed consent from the participants. Women carriers of hemophilia will be identified through the registry of selected chapters of hemophilia society, Karnataka. Qualitative data collection will be carried out by a detailed interview through an audio recording till the data saturation happens. |