Paracetamol to enhance quality of life and daily function and to decrease care dependency in advanced dementia: A randomized, double-blind, placebo-controlled crossover trial in long-term care facilities.

Paracetamol to enhance quality of life and daily function and to decrease care dependency in advanced dementia: A randomized, double-blind, placebo-controlled crossover trial in long-term care facilities. - Quality of life and Paracetamol In advanced Dementia (Q-PID trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47642

Enrollment

Registered

2018-11-15

Start date

2018-01-22

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Dementia

Interventions

Orally administered paracetamol at a dose of 3 grams a day the first 4 weeks (3x2 tablets of 500mg), followed by 2 weeks 2x2 +1x1 tablets a day) or corresponding placebo. Two treatment periods of si

Dementia

Long term care facility

Paracetamol

Quality of life

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Diagnosis of dementia, Reisberg Global Deterioration Scale 5-7 Age 65 years or older QUALIDEM (Quality of life) score below the expected median score of 70) Not using any pain medication one week before start study. Residents with PRN prescribed paracetamol ("as needed") are also eligible, if the use of paracetamol in the last week was less than 3 grams/week.

Exclusion criteria

Exclusion criteria: * Presence of a severe psychiatric disorder * Severe liver insufficiency/disease * Use of >4 units alcohol per day * Allergy to study drugs * Concomitant use of flucloxacillin, carbamazepine, fenytoïne, fenobarbital, isoniazide and/or rifampicine * Weight

Design outcomes

Primary

Measure	Time frame
The difference between baseline QoL and follow-up scores (QUALIDEM and DS-DAT).	—

Secondary

Measure	Time frame
Neuropsychiatric symptoms (NeuroPsychiatric Inventory-Nursing Homes) ADL (Katz-15) Care dependency (Care Dependency Scale) Dementia severity (Reisberg Global Deterioration Scale) Pain (MOBID-2 pain scale) Medication use	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)