Improving the prognosis of dizzy elderly: a three-arm validation and intervention study in general practice

When treating older patients with dizziness in primary care, the current
diagnosis oriented approach is insufficient. Often, it is not possible to
diagnose an underlying disease and even if a disease is diagnosed, therapeutic
options are often limited. In this study a prognosis oriented approach for
dizziness in older people in primary care will be investigated.

In this study we want to validate a risk score for chronic dizziness with
persistent impairment in older dizzy patients in general practice. Furthermore,
we want to investigate the effectiveness of a risk factor-guided, i.e. a
prognosis-oriented, intervention for dizzy older patients with a high risk of
persistent impairment.

The study protocol consists of two parts. Firstly, we will perform a validation
study to externally validate a 7-item risk score for chronic dizziness with
persistent impairment. Secondly, we will perform an intervention study, using a
cluster controlled clinical trial. In the intervention study we will compare
the effectiveness of a targeted intervention for dizzy older patients with a
high risk of persistent impairment with usual care during one year of
follow-up.

In older patients with a high risk of persistent impairment because of
dizziness we will compare a risk factor-guided intervention consisting of one,
two, or three of the following interventions: (1) medication adjustment in case
of the usage of >= 3 Fall Risk Increasing Drugs (FRIDs), (2) stepped care in
case of anxiety/depression, and (3) exercise therapy in case of impaired
functional mobility. All three interventions are evidence based and usual care
for the above-mentioned risk factors.

A group of 125 patients of the validation group will receive 3 questionnaires
by mail at baseline and at 6 and 12 months follow-up. The group of 250 patients
participating in the intervention study will receive four questionnaires at
baseline, 3, 6 and 12 months follow-up, and will keep up a diary to report
dizziness frequency and fall frequency. Filling out the questionnaires will
take about 30 minutes each time. Keeping up the diary will take 1 minute every
week.

All 375 patients will be subjected to a baseline assessment of 30 minutes at
their home including a structured interview and a simple test to determine the
functional mobility of the patient.

Patients in the intervention group (n=125) will receive - in addition to usual
(general practice) care - a targeted intervention, depending on the presence of
specific risk-factors. Participating in the intervention 'medication adjustment
' will ask one additional visit to the patients' GP to discuss the outcomes of
the medication evaluation. Time investment for the patient when participating
in the stepped-care program depends on the severity of the anxiety/depression:
the more severe the complaints of the patient, the more time the stepped-care
program will cost. We expect an average time investment of of 4 hours per
patients in the stepped-care program. The exercise program takes 2 sessions of
50 minutes every week for 8 weeks.

Patients in the control group (n=125) and validation group (n=125) will receive
(general practice) care as usual. No treatment will be denied to any
participants nor will it be postponed. There are no major medical health risks
for participants in this study. The experimental group may benefit from the
intervention by a reduction of impairment due to dizziness and/or a decrease
in dizziness frequency.