Assessing the quality and effectiveness of an updated preventive home visit programme for ambulatory frail older Japanese people: research protocol for a randomized controlled trial.

Aim: To describe the programme and research protocol of our updated preventive home visit programme for ambulatory frail older adults in the Japanese Long-Term Care Insurance system.
Background: Our previous trials have shown that the nature of recommendations during preventive home visits is a key issue. The present programme has updated our previous one by including a unique structured assessment with treatment recommendations tied to an ongoing programme for quality assurance.
Design: A randomized, controlled trial.
Methods: Eligible participants (n = 360) will be randomly assigned to home visit (n = 179) and control (n = 181) groups in three suburban municipalities. Nurses provide recommendations based on structured assessments to participants in visit group every 3 months from September 2011-October 2013. The primary outcomes are parameters related to quality of life, including activities of daily living, instrumental activities of daily living, depression, cognitive capacity, daily-life satisfaction and self-efficacy for health promotion; these are collected by mail at baseline, 12 and 24 months. The secondary outcome is long-term care use over the study period. To evaluate the visit process, we are qualitatively analysing documentation data from the assessment sheet and chart.
Conclusion: This study is collecting and analysing evidence regarding the process and outcomes of preventive home visits based on structured care-need assessments.
Trial Registration: The study protocol was registered for the UMIN clinical registry approved by ICMJE (No. UMIN000006463, October 04, 2011).
(© 2014 John Wiley & Sons Ltd.)