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Discontinuation of ANtihypertensive Treatment in Older people with dementia living in a Nursing home

Discontinuation of ANtihypertensive Treatment in Older people with dementia living in a Nursing home - Danton Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50258
Enrollment
492
Registered
2018-10-15
Start date
2018-11-27
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dementia neuropsychiatric symptoms

Interventions

Randomization to discontinuation (n=246) or continuation (n=246) of antihypertensive treatment during 8 months. Discontinuation of antihypertensive treatment aims to achieve a systolic blood pressur

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: An potential subject who meets any of the following criteria will be excluded from participation: • recent (

Design outcomes

Primary

MeasureTime frame
The co-primary outcome measures are the differences in change of scores between 0 and 4 months on the Neuropsychiatric Inventory - Nursing Homes (NPI-NH) and quality of life (Qualidem). Long-term effects on primary and secondary outcomes will be analysed over 8 months

Secondary

MeasureTime frame
Secondary outcome measures include NPS registered in the medical records, care dependency, cognitive function, general daily functioning, care-related quality of life, orthostatic hypotension, incident falls, and psychotropic medication use. Long-term effects on primary and secondary outcomes will be analysed over 8 months. In addition, cost-effectiveness will be evaluated.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)