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van CCT (UK)

van CCT (UK)

Quality of life and Paracetamol In advanced Dementia

- candidate number28046
- NTR NumberNTR6766
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-okt-2017
- Secondary IDsABR registration number: NL60476.058.17. CCMO
- Public TitleQuality of life and Paracetamol In advanced Dementia
- Scientific TitleParacetamol 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
- hypothesisRegularly scheduled administration of paracetamol, compared to placebo, leads to better quality of life, daily functioning, mood, and less pain, care dependency, behavioural problems and psychotrophic medication use.
- Healt Condition(s) or Problem(s) studiedQuality of life, Nursing home, Paracetamol, Advanced dementia
- Inclusion criteriaDiagnosis 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 not more than 1 gram/day and less than 3 grams/week
- Exclusion criteriaPresence 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, fenyto´ne, fenobarbital, isoniazide and/or rifampicine, Weight < 50 kg
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-mrt-2019
- Target number of participants95
- InterventionsSubjects will receive either orally administered paracetamol at a maximum dose of 3 grams (3 x 2 tablets of 500 mg each) daily for 4 weeks, followed by 2 weeks 2.5 grams, according to recent protocols of chronic use of paracetamol in older people, or placebo tablets. A six week administration period of corresponding placebo (or vice versa) follows, separated by a washout period of 7 days. The placebo tablets will resemble the paracetamol tablets in colour, taste and composition.
- Primary outcomeQuality of life: QUALIDEM, DS-DAT
- Secondary outcomeNeuropsychiatric symptoms of dementia (NPI-NH)
ADL functioning (Katz-15)
Care dependency (CDS)
Pain (MOBID-2)
Medication use
- TimepointsT0: Screening for in - and exclusion criteria: Demographic data (age, gender), dementia severity (Reisberg GDS), comorbidity (FCI), Quality of life (QUALIDEM, DS-DAT)

After being enrolled, measurements in week 1, 6, 7 and 12 (starting and ending points of study medication periods):
Quality of life (QUALIDEM, DS-DAT), Neuropsychiatric symptoms (NPI-NH), ADL functioning (Katz-15), Care dependency (CDS), Pain (MOBID-2), medication use
- Trial web site
- statusplanned
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZonMw, Bestemmingsfonds Verpleeghuisgeneeskunde (HGOG)
- Publications
- Brief summaryUndiagnosed and untreated pain is a serious and frequent problem in persons with advanced dementia, leading to behavioural problems. Although pain is difficult to assess in persons with advanced dementia, the impact on quality of life (QoL) is believed to be huge. In addition, recent studies suggest that pain also has a negative impact on the course of activities of daily living (ADL) function. Until now, there are no proven effective interventions on QoL in persons with dementia in a long-term care facility. However, several interventions are effective in diminishing mediators of QoL (challenging behaviour, depressed mood, sleeping disorders), including pharmacological treatment of pain. Social participation can also be seen as an indication for QoL, and has been shown to benefit from administration of paracetamol. However, so far no intervention studies are available that investigated the effects of pain management on QoL in advanced dementia directly.
The overall aim of this study is to achieve optimal QoL and ADL function in long term care facility (LTCF) residents with moderate to (very) severe dementia and moderate to low QoL, and to achieve less care dependency through pain treatment with paracetamol
- Main changes (audit trail)
- RECORD20-okt-2017 - 5-nov-2017

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