Effects of home visits by home nurses to elderly people with health problems: design of a randomised clinical trial in the Netherlands [ISRCTN92017183]

Abstract

The study is carried out as a parallel group randomised trial. To screen eligible participants, we sent a postal questionnaire to 4901 elderly people (70-84 years) living at home in a town in the south of the Netherlands. After applying inclusion criteria (e.g., self-reported poor health status) and exclusion criteria (e.g., those who already receive home nursing care), we selected 330 participants. They entered the randomisation procedure; 160 were allocated to the intervention group and 170 to the control group. The intervention consists of (at least) 8 systematic home visits over an 18 months period. Experienced home nurses from the local home care organisation carry out the visits. The control group receives usual care. Effects on health status are measured by means of postal questionnaires after 12 months, 18 months (the end of the intervention period) and after 24 months (the end of 6-months follow-up), and face-to-face interviews after 18 months. Data on mortality and service use are continuously registered during 24 months. A cost-benefit analysis is included. The design and setting of the study, the selection of eligible participants and the study interventions are described in this article. Other included items are: the primary and secondary outcome measures, the statistical analysis and the economic evaluation.