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Published on: August 1, 2019
Motivation and frustration in cardiology trial participation: the patient perspective
Silmara Meneguin1, Luiz Antônio Machado Cesar
1Department of Nursing, Botucatu School of Medicine, University Estadual Paulista, Botucatu, SP, Brasil.
Insights
Patient motivation in cardiology clinical trials stems from potential personal benefit. However, perceived risks and frequent visits can cause frustration and withdrawal.
Area of Science:
- Cardiovascular Medicine
- Clinical Trial Research
- Patient-Centric Studies
Background:
- Human participation in clinical cardiology trials is crucial for advancing medical knowledge.
- Understanding participant motivations and frustrations is vital for improving trial design and recruitment.
- Limited data exists on patient perceptions of their involvement in cardiology studies.
Purpose of the Study:
- To investigate the primary motivators for patient participation in hypertension and coronary arterial disease clinical trials.
- To identify factors contributing to participant frustration and potential withdrawal from these trials.
Main Methods:
- A questionnaire-based study involving 80 patients who previously participated in phases II, III, or IV clinical trials.
- Participants were categorized into two groups: placebo-controlled trials (Group I) and active-controlled trials with a placebo washout (Group II).
- Data collected on socio-demographic characteristics, motivations, and reasons for withdrawal.
Main Results:
- The primary motivation for participation in approximately 60% of patients was the expectation of personal health benefits.
- Reasons for withdrawal included perceived risks in placebo-controlled trials (Group I) and the burden of frequent institutional visits (Group II).
- Fear of discontinuing hospital treatment was not a significant factor for patient withdrawal.
Conclusions:
- The potential for therapeutic benefit remains a strong driver for patient enrollment in cardiology clinical trials.
- Addressing participant concerns regarding perceived risks and logistical burdens is essential for trial retention.
- Future trial designs should consider patient-reported outcomes and experiences to enhance engagement.
Objective:
The participation of humans in clinical cardiology trials remains essential, but little is known regarding participant perceptions of such studies. We examined the factors that motivated participation in such studies, as well as those that led to participant frustration.
Methods:
Patients who had participated in hypertension and coronary arterial disease (phases II, III, and IV) clinical trials were invited to answer a questionnaire. They were divided into two groups: Group I, which included participants in placebo-controlled clinical trials after randomization, and Group II, which included participants in clinical trials in which the tested treatment was compared to another drug after randomization and in which a placebo was used in the washout period.
Results:
Eighty patients (47 patients in Group I and 33 patients in Group II) with different socio-demographic characteristics were interviewed. Approximately 60% of the patients were motivated to participate in the trial with the expectation of personal benefit. Nine participants (11.2%) expressed the desire to withdraw, which was due to their perception of risk during the testing in the clinical trial (Group I) and to the necessity of repeated returns to the institution (Group II). However, the patients did not withdraw due to fear of termination of hospital treatment.
Conclusions:
Although this study had a small patient sample, the possibility of receiving a benefit from the new tested treatment was consistently reported as a motivation to participate in the trials.
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