A Prospective, Multicenter Study to Measure the Impact of a Speaking Book on Patient Understanding of Clinical Research Knowledge (The SOUND Study).

December 26, 2024| Completed Project | Reading time: 5 min

Introduction

Kintampo Health Research Centre (KHRC) carried out this innovative two-month Study to help improve public understanding of clinical trials using an innovative tool called the Speaking Book. This ‘SOUND Study’ funded by Novartis and sought to address a significant challenge: lack of awareness, misconceptions, and stigma surrounding clinical trials, especially in low- and middle-income countries. Findings from this study will go a long way to encourage more people to participate in clinical trials to ultimately improve health outcomes globally.

Investigators

Dr. Seyram Kaali, Dr. Samuel Harrison, Dr. Prince Darko Agyapong, Dr. Cynthia Yaa Bema, Dr. Felicia Serwah, Mr. Fred Kanyoke, Mr. Francis Mensah Kornu, Mr. Zakariah Buwah, Mr. Elisha Adeniji.

Background

It is important for innovative health care solutions to reach remote corners of the world including low- and middle-income countries; however, one of the key barriers for access is the lack of data generated in this population which is attributed to lack of awareness, misconceptions and social stigma associated with clinical trials. There is a sharp contrast in participants enrolled in clinical trials and the global population especially in low-to-middle income countries where there is an increasing trend in noncommunicable disease such as cancer, diabetes, metabolic syndrome, and other maladies. Considering the disease burden and other factors such as low costs, medical expertise and good hospital facilities, these countries could be attractive for many Multinational Companies conducting trials.

Several articles talk about increase in number of clinical trials (CTs) and revenues but few talks about “Trial Participants (TPs)” who contribute to the advancement of science and to the revenue. Few researchers have looked at whether the TPs who get recruited in CTs are aware of what CTs are and if participation agreement is purely their conscious decision. Studies have made known that fear, distrust or suspicion of research, apprehension and skepticism could hinder awareness about the CTs, especially among minorities. Language and literacy barriers may make it difficult for some people to understand which may be the main barrier for awareness.

Objectives
The objective of this study is to evaluate the improvement in clinical trial knowledge with the Speaking Book.

Study Methodology
The primary objective is to evaluate the Improvement in clinical trial knowledge with the Speaking Book in adults with benign haemoglobinopathy who have never participated in a clinical trial or have little clinical research awareness, targeting about 205 participants in at least four countries (Ghana, Kenya, India and Egypt). The target number for the Kintampo site is 30 participants. The eligible participants will be grouped randomly into the CONTROL (participants who will not receive the speaking book) and REVIEW (participants receiving the speaking book) groups in 1:1 ratio.

At Visit 1/Day 1/Baseline, all centers will conduct their normal standard procedure for explaining clinical trial participation to patients enrolled in the Control Group. The study team will then administer the Clinical Trial Knowledge Questionnaire (CTKQ) to these patients and ask them to return to the center at Visit 2. Once procedures for the Control Group are complete, the Review Group will undergo their baseline/Visit 1 procedures. The site team will review the Speaking Book with the patients to ensure they have a good understanding of the contents.

Expected Outcomes
The study aims to show that participants who use the Speaking Book (known as the review group) will have at least 25% better understanding of clinical trials compared to those who only receive the standard education from their clinic team (known as the control group).

Funding
Novartis

Duration
2 months

Start Date
January 2024