Discontinuation of ANtihypertensive Treatment in Older people with dementia living in a Nursing home
- Conditions
- dementianeuropsychiatric symptoms10012272
- Registration Number
- NL-OMON50258
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 492
Eligible to participate in this study, a subject must meet all of the following
criteria:
• being admitted in nursing home
• have a diagnosis of moderate to severe dementia according to the Reisberg
Global Deterioration Scale (score 5-6-7)
• are currently on antihypertensive treatment with a calcium antagonist,
diuretic, ACE-inhibitor, beta-blocker or angiotensin-II-receptor blocker
prescribed for hypertension
• have a systolic blood pressure <=160mmHg (average of two last blood pressure
measurements)
An potential subject who meets any of the following criteria will be excluded
from participation:
• recent (<12 months) history of myocardial infarction, stroke, coronary
reperfusion procedures (CABG/PCI)
• heart failure NYHA class III or IV
• current angina pectoris
• have a life-expectancy less than 4 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The co-primary outcome measures are the differences in change of scores between<br /><br>0 and 4 months on the Neuropsychiatric Inventory - Nursing Homes (NPI-NH) and<br /><br>quality of life (Qualidem).<br /><br><br /><br>Long-term effects on primary and secondary outcomes will be analysed over 8<br /><br>months</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures include NPS registered in the medical records, care<br /><br>dependency, cognitive function, general daily functioning, care-related quality<br /><br>of life, orthostatic hypotension, incident falls, and psychotropic medication<br /><br>use.<br /><br><br /><br>Long-term effects on primary and secondary outcomes will be analysed over 8<br /><br>months. In addition, cost-effectiveness will be evaluated.</p><br>