Abstract
BackgroundNo proven effective interventions on quality of life (QoL) are available for persons with dementia in a long-term care facility (LTCF). However, several interventions are effective in diminishing mediators of QoL (i.e. challenging behaviour, depressed mood, sleeping disorders), including pain treatment. Un(der)diagnosed and un(der)treated pain is a serious and frequent problem in persons with dementia. Also, although pain is difficult to assess in this group, the impact on QoL is probably considerable. There is evidence that pain has a negative impact on behaviour, mood, functioning and social participation, and benefit may be derived from use of paracetamol. Therefore, in LTCF residents with advanced dementia, this study aims to evaluate the effect of scheduled pain treatment with paracetamol on QoL, neuropsychiatric symptoms, ADL function, pain, care dependency, and (change in) use of psychotropic and pain medication.MethodsThis randomised, double-blind, placebo-controlled crossover trial will include 95 patients with: 1) age ≥ 65 years, 2) advanced dementia (Reisberg Global Deterioration Scale 5–7), and 3) QUALIDEM score ≤ 70. Exclusion criteria are the regular use of pain treatment, allergies to the study drugs, severe liver insufficiency or disease, use of > 4 units of alcohol/day, weight < 50 kg, and/or concomitant use of flucloxacillin. The two treatment periods of six weeks each (paracetamol and corresponding placebo) will be separated by a washout period of seven days. Primary outcome is effect on QoL (QUALIDEM and DS-DAT) and secondary outcome is effect on neuropsychiatric symptoms, ADL function, pain, care dependency, and (change in) use of psychotropic and pain medication (all compared to baseline).DiscussionIf regular treatment with paracetamol proves to be beneficial for QoL, this could have major implications for daily practice in long-term care. Information from this study may help professionals in their decision making regarding the prescription of pain medication to improve the QoL of persons with dementia and a low QoL.Trial registrationThe trial was registered on the Netherlands Trial Register (NTR6766); Trial registration date: 20th October, 2017.
Highlights
No proven effective interventions on quality of life (QoL) are available for persons with dementia in a long-term care facility (LTCF)
Aims of the Q-PID trial The primary objective of the Q-PID trial is to evaluate the effect of scheduled administration of pain treatment with paracetamol on QoL of people with advanced dementia in LTCFs
Secondary aims are to evaluate the effects of regular pain treatment with paracetamol on neuropsychiatric symptoms, activities of daily living (ADL) function, pain, care dependency, and use of psychotropic and pain medication
Summary
Design and study population This 13-week double-blind, randomised, placebo-controlled crossover trial, is designed to include 95 residents with advanced dementia, being admitted to LTCFs affiliated with the UNC-ZH. Quality of life At baseline and at follow-up, QoL will be measured with the QUALIDEM, which includes 37 items for observation by nurses on nine QoL domains (care relationships, positive affect, negative affect, restless tense, behaviour, positive self-image, social relations, social isolation, feeling at home, and having something to do) [17, 18] This is a dementia-specific QoL measurement (initially developed for the Dutch population) and has satisfactory reliability and validity, in other countries [17, 19] Only the 18 items that are applicable for very severe dementia (GDS 7) will be included in this proposed study (as recommended by the authors in the QUALIDEM manual) [20]. We look for the existence of a period effect, i.e. whether the
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