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Study to measure the impact of a speaking book on patient Understanding of clinical research knowledge.

Prospective, Multicenter Study to measure the impact of a speaking bOok on patient UNderstanDing of clinical research knowledge: The SOUND Study - The SOUND Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068453
Enrollment
205
Registered
2024-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z768- Persons encountering health services in other specified circumstances

Interventions

Intervention1: 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.

Sponsors

Novartis Healthcare Pvt Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the Improvement in clinical trial knowledge with the Speaking Book. At least a 25 percent improvement in willingnessTimepoint: Visit 1: Baseline and Visit 2: Approx 4 wks (+/-) 2 wks

Secondary

MeasureTime frame
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 trialTimepoint: Visit 1 Baseline Visit 2 Approx 4 wks plus or minus 2 wks

Countries

Ghana, India, Kenya

Contacts

Public ContactMr. Barun Rai

Novartis Healthcare Pvt Ltd.

ashray_kanchan.naik@novartis.com9821520558

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026