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An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial.

Publication ,  Journal Article
Chong, S-A; Ong, YY; Subramaniam, M; Abdin, E; Marx, CE; Campbell, AV
Published in: Contemp Clin Trials
September 2009

Enrollment of an adequate number of subjects for a clinical trial is a perennial challenge and this might arguably be even more difficult and complex in trials involving patients with schizophrenia. In this paper, we used a modification of the Prospective Preference Approach (PPA) as a prelude to an actual randomized placebo-controlled trial of a cognitive-enhancing agent for patients with schizophrenia. This approach sought to test and enhance subjects' understanding of the key concepts of the trial, and administered the PPA at baseline and following a brief educational module. The motivations and concerns regarding potential participation in the proposed trial were also elicited by the PPA. Of one hundred ninety patients with schizophrenia recruited for this PPA study, only 12 (6.3%) were assessed to have understood all key trial-related concepts after the initial explanation and baseline PPA administration (prior to the educational module). Following the education module, however, there was significant increase in the number of patients who understood all key trial elements. Younger age and higher level of education were significant factors associated with better understanding of the proposed trial. The main reasons cited for wishing to participate in clinical trials were personal medical benefits and altruistic desire to help others. Concerns regarding the safety of the trial medication were expressed in over 80% of the subjects. PPA administration with educational module supplementation may provide a valuable addition to clinical trial procedures in patients with schizophrenia.

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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

September 2009

Volume

30

Issue

5

Start / End Page

446 / 450

Location

United States

Related Subject Headings

  • Social Perception
  • Singapore
  • Schizophrenia
  • Randomized Controlled Trials as Topic
  • Public Health
  • Patient Education as Topic
  • Odds Ratio
  • Motivation
  • Male
  • Informed Consent
 

Citation

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Chong, S.-A., Ong, Y. Y., Subramaniam, M., Abdin, E., Marx, C. E., & Campbell, A. V. (2009). An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial. Contemp Clin Trials, 30(5), 446–450. https://doi.org/10.1016/j.cct.2009.04.006
Chong, Siow-Ann, Yuen Yeng Ong, Mythily Subramaniam, Edimansyah Abdin, Christine E. Marx, and Alastair Vincent Campbell. “An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial.Contemp Clin Trials 30, no. 5 (September 2009): 446–50. https://doi.org/10.1016/j.cct.2009.04.006.
Chong S-A, Ong YY, Subramaniam M, Abdin E, Marx CE, Campbell AV. An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial. Contemp Clin Trials. 2009 Sep;30(5):446–50.
Chong, Siow-Ann, et al. “An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial.Contemp Clin Trials, vol. 30, no. 5, Sept. 2009, pp. 446–50. Pubmed, doi:10.1016/j.cct.2009.04.006.
Chong S-A, Ong YY, Subramaniam M, Abdin E, Marx CE, Campbell AV. An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial. Contemp Clin Trials. 2009 Sep;30(5):446–450.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

September 2009

Volume

30

Issue

5

Start / End Page

446 / 450

Location

United States

Related Subject Headings

  • Social Perception
  • Singapore
  • Schizophrenia
  • Randomized Controlled Trials as Topic
  • Public Health
  • Patient Education as Topic
  • Odds Ratio
  • Motivation
  • Male
  • Informed Consent