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PneuMonitor - Comfort and prognosis in patients with pneumonia and dementia


- candidate number21781
- NTR NumberNTR5071
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2015
- Secondary IDs91711339 NWO
- Public TitlePneuMonitor - Comfort and prognosis in patients with pneumonia and dementia
- Scientific TitlePneuMonitor - Comfort and prognosis in patients with pneumonia and dementia
- ACRONYMPneuMonitor
- hypothesisImplementation of a practice guideline for optimal symptom relief in Dutch nursing homes will reduce suffering in patients with dementia and pneumonia.
- Healt Condition(s) or Problem(s) studiedDementia, Pneumonia
- Inclusion criteriaNursing home residents who reside on a psycho geriatric ward and develop a pneumonia according to clinical judgement (pneumonia most likely diagnosis)
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-mei-2015
- Target number of participants613
- InterventionsA practice guideline for optimal symptom relief based on evidence and consensus among national and international experts.
- Primary outcomeSuffering (Discomfort: Discomfort Scale Dementia of Alzheimer Type (DS-DAT); Pain: Pain Assessment In Advanced Dementia (PAINAD); comfort: End Of Life in Dementia Comfort Assessment in Dying (EOLD-CAD), respiratory difficulty: Respiratory Distress Observation Scale (RDOS)
- Secondary outcomeConsciousness and survival
- TimepointsOutcomes discomfort, pain and respiratory difficulty and conciousness: observations (when possible) twice daily on the day of diagnosis pneumonia (day 0) and day 1. Daily from day 2 until day 10, and one last time on day 13 or 14 or 15. Survival: minimum 3 months, maximum 3.5 years.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD. J.T. Steen, van der
- CONTACT for SCIENTIFIC QUERIESPhD. J.T. Steen, van der
- Sponsor/Initiator VU University Medical Center, EMGO Institute
- Funding
(Source(s) of Monetary or Material Support)
NWO
- Publicationsvan der Maaden T, van der Steen JT, de Vet HC, Achterberg WP, Boersma F, Schols JM, van Berkel JF, Mehr DR, Arcand M, Hoepelman AI, Koopmans RT, Hertogh CM. Development of a practice guideline for optimal symptom relief for patients with pneumonia and dementia in nursing homes using a Delphi study. Int J Geriatr Psychiatry. 2015 May;30(5):487-96
- Brief summaryMany people in western countries currently die with dementia. In up to two-thirds of these patients, pneumonia is the terminal event. Earlier work has indicated severe suffering, along with under treatment of symptoms of the pneumonia. Comfort care is appropriate when death is near, but prognostication is difficult.

The PneuMonitor study examines whether suffering in patients with dementia and pneumonia can be reduced by the implementation of an evidence and consensus based practice guideline for optimal symptom relief. This practice guideline was developed using a Delphi study, and consists of a checklist that lists symptoms of pneumonia, observational instruments for dyspnea and pain, and the core guideline that provides information about treatments to relieve symptoms of pneumonia. Matched pairs of thirty-two nursing homes that participated in the study (matched by location, number of psycho geriatric beds and baseline DS-DAT scores) were randomly assigned (cluster-randomization) to the control (usual care) or the intervention group. Regular independent observations for discomfort, pain and respiratory difficulty are performed from diagnosis of pneumonia until cure or death (within 14 days) to examine suffering.
- Main changes (audit trail)
- RECORD10-mrt-2015 - 20-apr-2015


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