NCT02483065

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
413

participants targeted

Target at P75+ for all trials

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

June 18, 2015

Last Update Submit

June 23, 2015

Conditions

Keywords

dementiahospital admissionmortalityhealth-related quality of lifeactivities of daily living

Outcome Measures

Primary Outcomes (1)

  • Mortality during hospitalization and at follow-up

    In-hospital mortality, and at follow-up: information on survival status of the patients was collected during hospitalization and assessed 3 months after discharge by telephone interview to patients or caregivers.

    Up to 3 months

Secondary Outcomes (11)

  • The Alzheimer's Disease Test (AD8)

    Up to 3 months

  • Assessment of Performance in Basic Activities of Daily Living: Barthel Index

    Up to 3 months

  • Instrumental Activities of Daily Living (IADL)

    Up to 3 months

  • EuroQoL 5-domain for Health-related quality of life (EQ-5D) (EuroQoL Group, 1990).

    Up to 3 months

  • The Quality of Life in Alzheimer's disease (QOL-AD)

    Up to 3 months

  • +6 more secondary outcomes

Study Arms (2)

inpatients with dementia

Other: mortality at discharge and 3-months after the admission in patients with and without dementia

inpatients without dementia

Other: mortality at discharge and 3-months after the admission in patients with and without dementia

Interventions

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.

inpatients with dementiainpatients without dementia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may not qualify if:

  • Patients with dementia (or caregivers) were excluded if they did not provide inform consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Inmaculada Moro, MSc

    Hospital Galdakao-Usansolo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 26, 2015

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Last Updated

June 26, 2015

Record last verified: 2015-06