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).