Clinical trial NCT02483065: Impact of Hospital Admission on Patients With Dementia
Official title: Impact of Hospital Admission on Patients With Dementia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Keywords: dementia
hospital admission
mortality
health-related quality of life
activities of daily living
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
Collaborators: name: Department of Health, Basque Country, Spain
First posted: 2015-06-26
Enrollment: 413
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For this prospective matched cohort study, the investigators recruited two groups of adults aged 75 years and older with an unplanned medical admission to any medical speciality between January 2012 and December 2014 in the Galdakao-Usansolo Hospital in the Basque Country (northern Spain), a 400-bed general teaching hospital serving a population of 300,000. It is one of the networks of public hospitals of the Basque Health Service, which provides free unrestricted care to nearly 100% of the population. One group (patients with dementia cohort) was drawn from patients with dementia, and a second group (patients without dementia cohort) of patients without dementia.

Brief summary: People with dementia have complex medical, social, and psychological needs and can be exacerbated by physical illness and the complex relationships between health care systems, patients and their families or caregivers. They are a vulnerable and fragile population that differs significantly from the population without dementia. Therefore, the investigators propose the following objectives: 1. To describe the evolution of dementia patients admitted during the study period in two hospitals in the Basque Health Service-Osakidetza and complications associated with such admissions. 2. To compare with a control group (matched by type of pathology, age and sex and adjusting for other clinical variables (severity of dementia ...) the patient's condition before and after admission, in terms of quality of life, dependency, instrumental activities of daily living and severity of dementia. 3. To compare the length of stay, complications, mortality rate, the degree of dependency and quality of life of patients with dementia compared to those without dementia, matched by groups of pathologies, gender and age.


Eligibility criteria: Inclusion Criteria:

* For the patients with dementia cohort, the inclusion criteria were: (a) Being patient aged over 75 years; (b) having been diagnosed with dementia according to the Diagnostic and Statistical Manual for Mental Disorders-IV (American Psychiatric Association, 1994) by any of the psychiatrists; (c) having received inpatient treatment by the time of the study in the hospital//with an unplanned medical admission to any medical speciality in the Galdakao-Usansolo Hospital (d) agreeing to participate voluntarily and providing written informed consent. Patients with dementia were included if a caregiver agreed to participate voluntarily. Caregiver is defined as any person who cares for a needy person in his or her direct environment on a regular basis and more or less as a matter of course. The caregiver is related (family, friend...) to the person receiving care and is not a professional caregiver (Shoenmakers et al., 2010).
* For the cognitive intact patients cohort, the inclusion criteria were patients without dementia admitted in the hospital by the time of the study, matched with patients with dementia, after controlling for age, gender and types of pathologies.

Exclusion Criteria:

* Patients with dementia (or caregivers) were excluded if they did not provide inform consent.
* The exclusion criteria for patients without dementia were disorders interfering with psychometric assessment, or not given written informed consent.

Primary outcomes:
measure: Mortality during hospitalization and at follow-up
timeFrame: Up to 3 months
Secondary outcomes:
measure: The Alzheimer's Disease Test (AD8)
timeFrame: Up to 3 months
measure: Assessment of Performance in Basic Activities of Daily Living: Barthel Index
timeFrame: Up to 3 months
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: Up to 3 months
measure: EuroQoL 5-domain for Health-related quality of life (EQ-5D) (EuroQoL Group, 1990).
timeFrame: Up to 3 months
measure: The Quality of Life in Alzheimer's disease (QOL-AD)
timeFrame: Up to 3 months
measure: Caregiver's burden was evaluated with the Zarit Scale
timeFrame: Up to 3 months
measure: Diagnosis
timeFrame: Up to 3 months
measure: Body Mass Index (BMI)
timeFrame: Up to 3 months
measure: Nutritional status
timeFrame: Up to 3 months
measure: Level of consciousness: The Glasgow Coma Scale (GCS)
timeFrame: Up to 3 months
measure: Pressure Ulcer risk: the Braden Scale and the Gosnell Scale were employed.
timeFrame: Up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Galdakao-Usansolo
name: Inmaculada Moro, MSc
role: PRINCIPAL_INVESTIGATOR
References: