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
Pijn kan bij mensen met dementie leiden tot gedragsproblemen en problemen in het dagelijks functioneren. Pijn komt vaak voor en heeft een grote invloed op kwaliteit van leven.
Doel
In dit project is onderzocht of paracetamol kwaliteit van leven, functioneren bij algemene dagelijkse levensverrichtingen (ADL), zorgafhankelijkheid, pijn en gedrag van verpleeghuisbewoners met dementie kon verbeteren.
Werkwijze
Het onderzoek vond plaats tussen januari 2018-juni 2019. Alle 95 deelnemers kregen paracetamol én een placebo. Loting bepaalde de volgorde van de behandeling. Beide behandelperiodes duurden 6 weken met daartussen een uitwasperiode van 1 week. De deelnemers, artsen, verzorging, en onderzoekers wisten niet welke behandeling de deelnemers op welk moment kregen.
Resultaten
Uit het onderzoek bleek dat paracetamol in vergelijking met placebo geen positief effect had op kwaliteit van leven, ADL functioneren, zorgafhankelijkheid, pijn en onbegrepen gedrag bij personen met dementie. Wel hadden enkele personen duidelijk baat van paracetamol. Het is daarom interessant om meer specifiek te weten te komen welke personen met dementie baat zouden kunnen hebben bij een behandeling met paracetamol.
Animatievideo
Bekijk de animatievideo over de resultaten van de studie op YouTube:
Aanbevelingen
- Het is belangrijk om meer specifiek te weten te komen welke individuele personen met gevorderde dementie baat kunnen hebben bij pijnbehandeling met paracetamol ter verbetering van kwaliteit van leven.
- Voor clinici is het belangrijk om te erkennen dat een goede beoordeling, monitoring en multi-domein benadering van vitaal belang is voor het verbeteren van kwaliteit van leven in deze kwetsbare groep.
Interview
Kun je met van een vaste lage dosis paracetamol de kwaliteit van leven van mensen met dementie verbeteren? In een interview lichten projectleider en gezondheids-wetenschapper Monique Caljouw en specialist ouderengeneeskunde in opleiding Paulien van Dam de achtergronden van hun onderzoek toe.
Andere ZonMw-projecten
Bekijk de andere ZonMw-projecten waarbij Monique Caljouw betrokken is:
Producten
Auteur: van Dam PH
Auteur: Paulien H. van Dam
Link: https://www.youtube.com/watch?v=bF1fVhrxD-A
Auteur: Paulien van Dam en UNC-ZH
Link: https://www.youtube.com/watch?v=gkUSWff9Qe4
Auteur: van Dam PH, Achterberg WP, Gussekloo J, Husebø BS, Caljouw MAA
Auteur: van Dam PH
Auteur: van Dam PH
Auteur: van Dam PH
Auteur: van Dam PH
Auteur: Van Dam PH, Achterberg WP, Husebo BS, Caljouw MAA
Auteur: van Dam PH
Auteur: Caljouw MAA, Dam PH van
Auteur: Van Dam PH, Achterberg WP, Husebo, BS, Caljouw MAA
Auteur: Caljouw MAA, van Dam PH
Auteur: van Dam PH, Achterberg WP, Gussekloo J, Husebø BS, Caljouw MAA
Auteur: van Dam PH
Auteur: van Dam PH, Caljouw MAA, Slettebø DD, Aasmulb I, Husebø BS, Achterberg WP
Auteur: van Dam PH
Auteur: van Dam PH
Auteur: van Dam PH
Auteur: P.H. van Dam, W.P. Achterberg, B.S. Husebo, M.A.A. Caljouw
Magazine: BMC Medicine
Auteur: van Dam, Paulien H., Achterberg, Wilco P., Gussekloo, Jacobijn, Husebo, Bettina S., Caljouw, Monique A. A.
Magazine: BMC Geriatrics
Verslagen
Samenvatting van de aanvraag
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.