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.

Projectomschrijving

Undiagnosed 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.

Aim

This study investigated whether paracetamol (acetaminophen) could improve quality of life, ADL functioning, care dependency, pain and behavior of nursing home residents with dementia.

The study took place between January 2018 and June 2019. All 95 participants received paracetamol and placebo. Participants received orally administered paracetamol (or placebo, if they are randomised into starting placebo first) at a daily dose of 3 g for four weeks (3 x 2 tablets of 500 mg each), followed by administration of 2.5 g/day for two weeks. Two treatment periods of six weeks, separated by a washout period of 7 days. Participants, nursing staff, physicians, investigators and research nurses are blinded to treatment.

Results

The study found that compared to placebo, paracetamol had no positive effect on quality of life, ADL functioning, care dependency, pain and behavior problems in persons with dementia. However, some persons clearly benefited from paracetamol. It is therefore interesting to find out more specifically which persons with dementia could benefit from treatment with paracetamol.

Trial register: https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6766.

Products

Title: Onderzoek verbeteren kwaliteit van leven van mensen met dementie
Author: van Dam PH
Title: Q-PID sessie. Werkt paracetamol bij vergevorderde dementie
Author: Paulien H. van Dam
Link: https://www.youtube.com/watch?v=bF1fVhrxD-A
Title: Werkt paracetamol bij gevorderde dementie?
Author: Paulien van Dam en UNC-ZH
Link: https://www.youtube.com/watch?v=gkUSWff9Qe4
Title: Quality of life and Paracetamol In advanced Dementia (Q-PID): Protocol of a Randomized Double Blind Placebo-controlled Cross-over Trial.
Author: van Dam PH, Achterberg WP, Gussekloo J, Husebø BS, Caljouw MAA
Title: Capita Selecta Spiegelbijeenkomst Radicaal vernieuwend onderwijs. Kwaliteit van leven en pijn bij dementie
Author: van Dam PH
Title: Resultaten en implicaties van de Q-PID studie
Author: van Dam PH
Title: Kwaliteit van leven en paracetamol gebruik bij gevorderde dementie
Author: van Dam PH
Title: Wereld Alzheimerdag lezing: pijn bij dementie: resultaten en imnplicaties van de Q-PID studie
Author: van Dam PH
Title: Does paracetamol improve quality of life, discomfort, functioning, care dependency, pain and neuropsychiatric symptoms in persons with advanced dementia?
Author: Van Dam PH, Achterberg WP, Husebo BS, Caljouw MAA
Title: Wat is het effect van paracetamol?
Author: van Dam PH
Title: Tips en tricks voor gerandomiseerde studies in het Verpleeghuis.
Author: Caljouw MAA, Dam PH van
Title: Effect of Paracetamol on Quality of Life, Wellbeing, Pain and Neuropsychiatric Problems of Persons with Advanced Dementia living in Long-Term Care Facilities: a Randomised Double-Blind Placebo-Controlled Crossover Trial.
Author: Van Dam PH, Achterberg WP, Husebo, BS, Caljouw MAA
Title: Kwaliteit van leven en paracetamol bij mensen met gevorderde dementie (Q-PID-studie).
Author: Caljouw MAA, van Dam PH
Title: Quality of life and Paracetamol In advanced Dementia (Q-PID): Protocol of a Randomized Double Blind Placebo-controlled Cross-over Trial.
Author: van Dam PH, Achterberg WP, Gussekloo J, Husebø BS, Caljouw MAA
Title: Gedragsproblemen bij dementie
Author: van Dam PH
Title: Pain Medication Use and Quality of Life in Persons with Advanced Dementia.
Author: van Dam PH, Caljouw MAA, Slettebø DD, Aasmulb I, Husebø BS, Achterberg WP
Title: Resultaten en implicaties Q-PID studie
Author: van Dam PH
Title: Gedragsproblemen bij dementie
Author: van Dam PH
Title: presentatie Q-PID onderzoek
Author: van Dam PH
Title: Does paracetamol improve quality of life, discomfort, pain and neuropsychiatric symptoms in persons with advanced dementia living in long-term care facilities? A randomised double-blind placebo-controlled crossover (Q-PID) trial.
Author: P.H. van Dam, W.P. Achterberg, B.S. Husebo, M.A.A. Caljouw
Magazine: BMC Medicine
Title: Quality of life and paracetamol in advanced dementia (Q-PID): protocol of a randomised double-blind placebo-controlled crossover trial
Author: van Dam, Paulien H., Achterberg, Wilco P., Gussekloo, Jacobijn, Husebo, Bettina S., Caljouw, Monique A. A.
Magazine: BMC Geriatrics
Title: Jan Stoopprijs voor artikel: ' Quality of Life and Pain Medication Use in Persons With Advanced Dementia Living in Long Term Care Facilities'

Reports


Summary of the application

Undiagnosed and untreated pain is a serious and frequent problem in persons with advanced dementia, leading to behavioural problems, such as decrease in daily functioning, sleep problems, depression and apathy. In many ways, pain therefore can negatively influence quality of life (QoL). Although pain is difficult to assess in persons with advanced dementia, the impact on QoL is believed to be huge. The long-term care facility (LTCF) organisations of the University Network of the Care sector South Holland (UNC-ZH) find their biggest challenge in preserving QoL in the course of dementia. Until now, there are no proven effective interventions on QoL in persons with dementia in LTCF, as was recently established in a systematic review. However, several interventions are effective in diminishing mediators (such as challenging behaviour and depressed mood) of QoL, including pharmacological treatment of pain. In a large Norwegian nursing home trial, pain treatment was effective in improving agitated behaviour as primary outcome, but also on secondary outcomes such as depression, sleep disturbances and apathy. In addition, Activities of Daily Living (ADL) was improved in the group treated with paracetamol. However, the stepwise approach of treating pain in this trial was not placebo-controlled and did not evaluate outcome measures of QoL. Also, social participation can be seen as a mediator 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. In addition, recent studies suggest that pain has a negative impact on the course of ADL function. The overall aim of this study is to achieve optimal QoL and ADL function in LTCF residents with moderate to very severe dementia and moderate QoL, and to achieve less care dependency through pain treatment with paracetamol. Objectives 1.Evaluate the effect of regularly scheduled administration of pain treatment (paracetamol) on QoL in LTCF residents with moderate to severe dementia. 2.Evaluate the effect of pain treatment (paracetamol) on ADL function and care dependency. 3.Evaluate the effect of paracetamol on pain, change in challenging behaviour and antipsychotic medication use. Research questions 1.What is the effect of regularly scheduled administration of paracetamol on the QoL of older persons with moderate to severe dementia in LTCF? 2.What is the effect of regularly scheduled administration of paracetamol on functioning in ADL and care dependency in this population? 3.What is the effect of regularly scheduled administration of paracetamol on pain, change in challenging behaviour and antipsychotic medication use? Study design: A randomized, double-blind, placebo-controlled crossover trial. Primary outcome:The difference between baseline QoL and follow-up scores (QUALIDEM and DS-DAT). Secondary outcomes: NPI-NH, Katz, care dependency, Reisberg Global Deterioration Scale, pain (MOBID-2, COST-pain instrument), and medication use, all compared to baseline. Intervention: Orally administered paracetamol at a maximum dose of 3 grams (3x2 tablets 500 mg) daily or corresponding placebo. Each treatment period is for six weeks, separated by a washout period of 7 days. Subject selection: Subjects will be recruited from the UNC-ZH (42 LTCF) and are eligible to participate when (1) diagnosis of dementia, Reisberg Global Deterioration Scale 5-7, (2) age >65 years, and (3) QUALIDEM score <60 and (4) not using any pain medication one week before start study. Excluded: (1) presence of a severe psychiatric disorder, (2) a life expectancy <6 months, (3) allergy to study drugs, (4) severe liver insufficiency/disease, use of >4 units alcohol per day. Measurements: Baseline (0 weeks), 6 weeks and baseline (7 weeks) and 13 weeks: comorbidity (only at baseline), daily functioning (Katz), care dependency (CDS), the Neuropsychiatric Inventory–Nursing Homes (NPI-NH), QoL (QUALIDEM, DS-DAT), medication use, pain (MOBID-2, COST pain instrument: PAIC), side-effects. Statistical considerations: To detect an interindividual difference of 10% QUALIDEM score with 80% power and alpha 0.05, we calculated a required sample of 70 residents. We assume an intraindividual standard deviation of 13 points, as derived from a previous study (STA-Op! Study, Pieper,et al., unpublished). Estimating a drop-out of 30% (mortality, loss to follow-up from other reasons, unwillingness to participate, paracetamol use, existing pain and discharge from LTFC) and invalid measurements of 5%, we will randomise 95 residents. This study will lead to a thesis and will generate knowledge that will be implemented in the comprehensive training program for elderly care physicians and guidelines. It also strengthens the cooperation between the LUMC and Bergen University, and the European COST cooperation Pain and Impaired cognition, Especially dementia.

Features

Project number:
839120006
Duration: 100%
Duration: 100 %
2016
2023
Related subsidy round:
Project lead and secretary:
dr. M.A.A. Caljouw
Responsible organisation:
Leids Universitair Medisch Centrum
Afbeelding

Elderly Medicine Research

To meet the changing care demand in the future, we need to improve the quality of elderly medicine. We therefore support academicization by funding PhD research projects for elderly medicine physicians training to become clinical researchers, and leave them with an abiding interest in research. Learn more about our ‘General Practice and Elderly Medicine Research’ Programme.