Overview

This trial is active, not recruiting.

Condition dementia
Treatment mortality at discharge and 3-months after the admission in patients with and without dementia
Sponsor Hospital Galdakao-Usansolo
Collaborator Department of Health, Basque Country, Spain
Start date January 2012
End date January 2015
Trial size 413 participants
Trial identifier NCT02483065, 2012111139

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
mortality at discharge and 3-months after the admission in patients with and without dementia
Patients diagnosed of dementia who ingresed the hospital were informed of the goals of the study and invited to voluntarily participate. In order to take part in the study, patients were required to provide informed consent. All participants were first screened with the Alzheimer's Disease Test. A diagnosis of dementia was generated by an independent clinician experienced in old age psychiatry using a structured clinical assessment based on operationalized DSM-IV criteria. Clinical data were gathered from hospital notes. Information on sociodemographic data, premorbid basic and instrumental activities of daily living, quality of life and burden of the caregiver was gathered from carers and review of hospital notes. In both cohorts, participants were telephoned 3 months after hospital admission to respond the follow-up questionnaires. Patients who decided not to answer them were considered lost to follow-up. All information was kept confidential.
mortality at discharge and 3-months after the admission in patients with and without dementia
Patients diagnosed of dementia who ingresed the hospital were informed of the goals of the study and invited to voluntarily participate. In order to take part in the study, patients were required to provide informed consent. All participants were first screened with the Alzheimer's Disease Test. A diagnosis of dementia was generated by an independent clinician experienced in old age psychiatry using a structured clinical assessment based on operationalized DSM-IV criteria. Clinical data were gathered from hospital notes. Information on sociodemographic data, premorbid basic and instrumental activities of daily living, quality of life and burden of the caregiver was gathered from carers and review of hospital notes. In both cohorts, participants were telephoned 3 months after hospital admission to respond the follow-up questionnaires. Patients who decided not to answer them were considered lost to follow-up. All information was kept confidential.

Primary Outcomes

Measure
Mortality during hospitalization and at follow-up
time frame: Up to 3 months

Secondary Outcomes

Measure
The Alzheimer's Disease Test (AD8)
time frame: Up to 3 months
Assessment of Performance in Basic Activities of Daily Living: Barthel Index
time frame: Up to 3 months
Instrumental Activities of Daily Living (IADL)
time frame: Up to 3 months
EuroQoL 5-domain for Health-related quality of life (EQ-5D) (EuroQoL Group, 1990).
time frame: Up to 3 months
The Quality of Life in Alzheimer's disease (QOL-AD)
time frame: Up to 3 months
Caregiver's burden was evaluated with the Zarit Scale
time frame: Up to 3 months
Diagnosis
time frame: Up to 3 months
Body Mass Index (BMI)
time frame: Up to 3 months
Nutritional status
time frame: Up to 3 months
Level of consciousness: The Glasgow Coma Scale (GCS)
time frame: Up to 3 months
Pressure Ulcer risk: the Braden Scale and the Gosnell Scale were employed.
time frame: Up to 3 months

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Impact of Hospital Admission on Patients With Dementia
Principal investigator Inmaculada Moro, MSc
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Hospital Galdakao-Usansolo.