|- candidate number||15882|
|- NTR Number||NTR4346|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-dec-2013|
|- Secondary IDs||ZonMw/HGOG 839110001|
|- Public Title||Improving the prognosis of older dizzy patients in general practice|
|- Scientific Title||Improving the prognosis of dizzy elderly: a three-arm validation and intervention study in general practice|
|- hypothesis||A risk-factor guided approach is more effective than usual care when treating dizziness in older patients in general practice.|
|- Healt Condition(s) or Problem(s) studied||Older adults, Disability, General practice, Prognosis|
|- Inclusion criteria||Patients of 65 years or older are eligible if they have consulted their GP for a new episode of dizziness, defined as recurrent
dizziness, including a giddy or rotational sensation, loss of balance, faint feeling, light-headedness, instability, or tendency to fall.|
Selected patients will be invited by their GP to participate in the study after confirming the following eligibility criteria:
a. Suspected current dizziness-related impairment.
b. The ability to speak, read and write Dutch.
c. No severe cognitive impairment.
d. No serious comorbid condition that precludes participation in an exercise programme.
e. No current enrolment in another – interfering – study.
|- Exclusion criteria||See above.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2015|
|- planned closingdate||31-dec-2019|
|- Target number of participants||200|
|- Interventions||The patients assigned to the intervention group will receive – in addition to usual care as described below – a targeted
intervention, consisting of a standardized intervention protocol for the risk factors ‘FRID (fall-risk-increasing drugs’, ‘anxiety and/or depression’, and ‘impaired functional mobility’.|
|- Primary outcome||Dizziness-related impairment, as measured by the Dizziness Handicap Inventory (DHI).
Health related quality of life, as measured by the SF-36.
Incidence of falls, as measured with a fall calendar.|
|- Secondary outcome||Anxiety or depression, as measured by the PRIME-MD Patient Health Questionnaire
Dizziness frequence, as measured by a dizziness calendar.|
Health care utilization, as measured by extracted data from the electronic medical records of all participants.
|- Timepoints||Baseline: questionnaires previously sent by mail and standardized baseline assessment during home visits.|
3-months/6-months/9-months/12-months: questionnaire sent by mail.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. O.R. Maarsingh|
|- CONTACT for SCIENTIFIC QUERIES||Dr. O.R. Maarsingh|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||15-dec-2013 - 18-feb-2014|