Treatment fidelity and acceptability of a cognition-focused intervention for older adults with mild cognitive impairment (MCI)

摘要

Background: Acceptability and fidelity assessments are an integral part of research, although few published trials comment on these processes in detail. Methods: We designed a randomized controlled trial (RCT) to identify the benefits of a cognition-focused intervention for older adults with mild cognitive impairment. Participants completed a six-item feedback questionnaire identifying level of satisfaction with their allocated intervention; this formed the acceptability assessment. Audio recordings of all sessions were reviewed and systematically assessed and rated for consistency of delivery (fidelity assessment). Results: Mean attendance (standard deviation) was 8.1 sessions (2.8) for the cognitive activity (CA) group and 8.4 (2.6) for the control general education group. There were no differences between groups regarding clarity and interest, willingness to attend the program in the community and pay a fee. Both groups reported the interventions to be relevant to their needs; however, this was rated more highly by the CA group (p < 0.01). There was high adherence to delivery of program content across both groups, yielding consistency scores above 95%. Conclusion: This study illustrates a systematic approach to assess acceptability and fidelity. The results show that the intervention was well received and met the needs of all participants. The manualized structure of the sessions facilitated the systematic implementation and reproducibility of the interventions. Acceptability and fidelity assessments have implications for the validity of assumptions made regarding trial outcomes and should therefore be included as standard process in RCTs.