| CTRI Number |
CTRI/2024/06/068453 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective, multicentre, qualitative research study] |
| Study Design |
Other |
|
Public Title of Study
|
Study to measure the impact of a speaking book on patient Understanding of clinical research knowledge. |
|
Scientific Title of Study
|
Prospective, Multicenter Study to measure the impact of a speaking bOok on patient UNderstanDing of clinical research knowledge: The SOUND Study |
| Trial Acronym |
The SOUND Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CSEG101A3002, Protocol Version 1.0, Dated 15-Sep-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipti Jain |
| Designation |
Principal Investigator |
| Affiliation |
Arihant Multispeciality Hospital |
| Address |
Arihant Multispeciality Hospital
Rambagh Road, near Baidyanath Square, Nagpur-440009
India
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9717267195 |
| Fax |
|
| Email |
diptyjain57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashray Naik |
| Designation |
Medical Expert |
| Affiliation |
Novartis Healthcare Pvt Ltd. |
| Address |
Inspire BKC, ‘G’ Block 6th & 7th floor, BKC Main Road Bandra
Kurla Complex Bandra (East), Mumbai 400 051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
9821520558 |
| Fax |
|
| Email |
ashray_kanchan.naik@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Barun Rai |
| Designation |
Senior Clinical Project Manager |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited
Salarpuria-Sattva Knowledge City
Raidurg, Rangareddy District
Madhapur / Hyderabad, Rangareddy 500081
Hyderabad
TELANGANA
500081
India |
| Phone |
04067581000 |
| Fax |
|
| Email |
barun.rai@novartis.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd. |
| Address |
Inspire BKC, ‘G’ Block
6th & 7th floor, BKC Main Road
Bandra Kurla Complex
Bandra (East), Mumbai 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Ghana
India
Kenya |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dipty Jain |
Arihant Multispeciality Hospital |
Room no. 2 of Endoscopy unit, Second floor, Research Unit,
Arihant Multispeciality Hospital,
Rambagh Road, Near Baidyanath square,
Nagpur - 440009
Nagpur
MAHARASHTRA |
9373103579
diptyjain57@gmail.com |
| Dr Bharat J Parmar |
Zydus Medical College & Hospital |
OPD office, Ground floor, Paediatric Department
Zydus Medical College & Hospital (Civil Hospital), Opp. Nehru Baug, Station Road Behind Bhaginisamaj,
Dahod, 389151.
Dohad
GUJARAT |
9825613362
bjpdr56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe college and Hospital,e, Zydus medical |
Approved |
| Institutional Ethics committee, Mahatme Eye bank Eye Hospital |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Normal standard procedure for explaining clinical trial participation to patients enrolled in the Control Group. At Visit 2/Final Visit: ALL patients (both Control and Review Groups) will return to the study center. The treating physician will be asked to complete two visits for the purposes of this study, Visit 1 and Visit 2 (+/- 2 weeks). This schedule is designed to cause minimal disruption to the patient’s normal follow-up routine. A one-month follow-up is considered a normal timeline for most benign haematological patients’ follow-up. |
| Intervention |
Speaking Book |
Speaking Book will be available with the subject for the entire duration of the study and they can listen to it whenever required until they come to the site for Visit 2.
The treating physician will be asked to complete two visits for the purposes of this study, Visit
1 and Visit 2 (+/- 2 weeks). This schedule is designed to cause minimal disruption to the
patient’s normal follow-up routine. A one-month follow-up is considered a normal timeline for most benign haematological patients’ follow-up
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Informed consent
2. Male and females
3. Minimum age 18 years
4. Minimal literacy levels as verified by Principle Investigator/Study Team
5. Disease of benign haemoglobinopathies
6. Patients who have never participated in a clinical trial previously. |
|
| ExclusionCriteria |
| Details |
1. Patients who are unable to comprehend or are unwilling to sign an informed consent form (ICF)
2. Any medical condition that, in the opinion of the Investigator, would interfere with completion of the study such as psychiatric. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Improvement in clinical trial knowledge with the Speaking Book. At least a 25 percent improvement in willingness |
Visit 1: Baseline and Visit 2: Approx 4 wks (+/-) 2 wks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the willingness to participate in a clinical trial after reviewing the Speaking Book. At least a 25 percent improvement in willingness to participate in a clinical trial |
Visit 1 Baseline
Visit 2 Approx 4 wks plus or minus 2 wks |
|
|
Target Sample Size
|
Total Sample Size="205"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "205"
Final Enrollment numbers achieved (India)="79" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
22/06/2024 |
| Date of Study Completion (India) |
03/09/2024 |
| Date of First Enrollment (Global) |
12/09/2023 |
| Date of Study Completion (Global) |
03/09/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Prospective, multicentre, qualitative research study to measure the impact of a Speaking Book on patient understanding of clinical trials. A series of 3 questionnaires (see Annex 1) to assess baseline level knowledge of clinical trials including perception of common misunderstandings and the impact and ease of the Speaking Book on increasing the level of clinical trial knowledge. This study also aims to highlight the patient groups needing most support and reinforcement of understanding. As there is NO randomisation procedure for this study, the only way blinding to the Speaking Book can be achieved is by recruiting patients to two groups. Assignment will be done at Sponsor level consecutively by site; the site will not know which group will be getting the Speaking Book (review group) Recruitment will continue until an even number of subjects have been recruited at the center resulting in the same number of patients in both Group A and Group B (1:1 randomisation) for an even comparison within the site. Patient numbering will be assigned at the trial level by the sponsor team. |