Feasibility study of a single-blind randomised controlled trial of an occupational therapy intervention

Scand J Occup Ther. 2016 Jul;23(4):260-71. doi: 10.3109/11038128.2015.1115548. Epub 2015 Nov 26.

Abstract

Background: Several factors facilitate or hinder efficacy research in occupational therapy. Strategies are needed, therefore, to support the successful implementation of trials.

Aim: To assess the feasibility of conducting a randomised controlled trial (RCT). The main feasibility objectives of this study were to assess the process, resources, management, and scientific basis of a trial RCT.

Material and methods: A total of 10 occupational therapists, between the ages of 30 and 55 (M 43.4; SD 8.3) with seven to 26 years' (M 14.3; SD 6.1) experience, participated in this study. Qualitative data collected included minutes of meetings, reports, and field notes. The data were analysed based on the principles of content analysis, using feasibility objectives as the main categories.

Results: Data analysis revealed strengths in relation to retention and inclusion criteria of participants, the study protocol, study organisation, and the competence of researchers. Weaknesses were found related to recruitment, randomisation, data collection, time for training and communication, commitment, and design.

Conclusion: The findings indicated that there are several factors which had a considerable impact on the implementation of an RCT in practice. However, it was useful to assess methods and procedures of the trial RCT as a basis to refine research plans.

Keywords: Implementation; pilot study; practice.

MeSH terms

  • Adult
  • Attention Deficit Disorder with Hyperactivity / diagnosis
  • Attention Deficit Disorder with Hyperactivity / therapy
  • Child
  • Developmental Disabilities / diagnosis
  • Developmental Disabilities / therapy
  • Feasibility Studies
  • Humans
  • Middle Aged
  • Motor Skills
  • Occupational Therapy*
  • Randomized Controlled Trials as Topic*
  • Research Design
  • Single-Blind Method