‘Discontinuation of antihypertensive treatment in older people with dementia living in a nursing home.’
Completed
- Conditions
- Older adults, Antihypertensive treatment, Dementia, Nursing home, Neuropsychiatric symptoms
- Registration Number
- NL-OMON27766
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 492
Inclusion Criteria
resident in a nursing home
- a diagnosis of moderate to severe dementia according to the Reisberg Global Deterioration Scale (score 5-6-7)
Exclusion Criteria
- recent (<12 months) history of myocardial infarction, stroke, coronary reperfusion procedures (CABG/PCI)
- heart failure NYHA class III or IV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The co-primary outcomes of this study are the change in neuropsychiatric symptoms in various domains measured with the Neuropsychiatric Inventory–Nursing Homes (NPI-NH) and quality of life measured with Qualidem between baseline and 4 month follow-up after randomisation.
- Secondary Outcome Measures
Name Time Method - NPS registered in the medical nursing home records during the study period, concomitant psychotropic medication use, psychosocial interventions started for NPS<br /><br>- apathy (abbreviated Apathy Evaluation Scale)<br /><br>- general daily functioning (Katz Index of Independence in activities of daily living), care dependency (Care Dependency Scale) <br /><br>- cognitive function (7-category Minimum Data Set Cognitive Performance Scale)<br /><br>- orthostatic hypotension<br /><br>- number of falls<br /><br>- caregiver burden (formal and informal caregivers, CarerQoL-7D)<br /><br><br />