DementiaNCT02483065
Impact of Hospital Admission on Patients With Dementia
An observational study of Dementia, run by Hospital Galdakao-Usansolo.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- mortality at discharge and 3-months after the admission in patients with and without dementia
- Type of treatment
- Injection or infusion
- How many people
- 413 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Dementia
- Being tested
- mortality at discharge and 3-months after the admission in patients with and without dementia
- Keywords
- dementia, hospital admission, mortality, health-related quality of life, activities of daily living
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mortality at discharge and 3-months after the admission in patients with and without dementiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| inpatients with dementia | Not described Receives: Other: mortality at discharge and 3-months after the admission in patients with and without dementia | |
| inpatients without dementia | Not described Receives: Other: mortality at discharge and 3-months after the admission in patients with and without dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (11)
The Alzheimer's Disease Test (AD8)
The Alzheimer's Disease Test (AD8) is a brief informant-based measure that reliably distinguishes individuals with very mild dementia from those with normal cognition [Galvin et al., 2005). The AD8 is composed of 8 items. In the initial development of the AD8, using a cutoff of 2 or greater on the AD8 to predict dementia gave the most desirable combination of sensitivity (85%) and specificity (86%).
Measured: Up to 3 months
Assessment of Performance in Basic Activities of Daily Living: Barthel Index
The Barthel Index is a scale used for the assessment of performance in basic activities of daily living [Mahoney \& Barthel, 1965) that considers 10 basic functions and yields a score of 0-100. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. It was categorized according to four cutoff points, which are as follows: 75-100 as reference (no-mild disability), 50-74 (moderate disability), 25-49 (severe disability), and 0-24 (completely dependent).
Measured: Up to 3 months
Instrumental Activities of Daily Living (IADL)
Lawton and Brody score was determined as a function of patient status 2 weeks before admission, based on the patient's medical history or information supplied by a caregiver. IADL assesses ability to use the telephone, to shop, to use transport, to cook, to do housework, to take medication and to handle finances. 0 indicates total dependence and the maximum score (8) indicates total independence.
Measured: Up to 3 months
EuroQoL 5-domain for Health-related quality of life (EQ-5D) (EuroQoL Group, 1990).
This well-established generic instrument which measures health-related QoL has five domains: mobility, self-care, pain/discomfort, usual activities, and anxiety/depression. The respondents also rate their own health today on a visual analogue scale from 100 (best imaginable health state) to 0 (worst imaginable health state). The data can be presented descriptively as a health profile, and a single index utility score can be calculated.
Measured: Up to 3 months
The Quality of Life in Alzheimer's disease (QOL-AD)
- The QOL-AD, a 13-item scale (range, 13 to 52, with higher scores indicating a better QOL) was used to examine AD-specific QOL (Logsdon et al., 1999). It has 13 items covering the domains of physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. These are scored on a 4-point Likert scale, ranging from 1 (poor) to 4 (excellent), with a possible total range from 13 to 52. The scale obtains separate ratings of the patient's QoL from both the patient and the caregiver, where available. These scores can be combined into a single score, weighting the person with dementia's own QoL score twice as heavily as the caregiver's. Early studies by Logsdon et al. (1999) suggest it to have good internal consistency, construct validity, and test-retest reliability. In this study, only the caregiver of the person with dementia's self-reported QoL was evaluated.
Measured: Up to 3 months
Caregiver's burden was evaluated with the Zarit Scale
A reduced Zarit scale is useful to identify caregiver burden in dementias (with a sensitivity 98,5% and specificity of 94,7%), and it is also easy to use (Gort et al., 2010). Fields explored with the 4 items Zarit scale were overburden (items 9 and 14), irritability (item 5) and the self-care (item 2). These are scored on a 5-point Likert scale, ranging from 1 (never) to 4 (most times). Higher score, more burden. (in online material)
Measured: Up to 3 months
Diagnosis
Measured: Up to 3 months
Body Mass Index (BMI)
Measured: Up to 3 months
Nutritional status
Blood test which included serum albumin, total cholesterol, electrolytes, total lymphocyte count was made.
Measured: Up to 3 months
Level of consciousness: The Glasgow Coma Scale (GCS)
The Glasgow Coma Scale (GCS) was employed to measure consciousness (Teasdale \& Jennett, 1974). In this scale the normal state merits a score of 15, and as level of consciousness deteriorates, the score becomes less. (Teasdale \& Jennett, 1974).
Measured: Up to 3 months
Pressure Ulcer risk: the Braden Scale and the Gosnell Scale were employed.
The Braden Scale (Bergstrom et al., 1987) is a summated rated scale comprised of 6 subscales: sensory perception, mobility, activity, moisture, nutrition, and friction and shear. The 6 subscales are rated from 1 to 4, except the friction and shear subscale, which is rated from 1 to 3. Each numerical rating has a definition of patient characteristics to evaluate when assigning a score. A total of 6 to 23 points is possible.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Collaborators
- Basque Government Department of Public Health
- Responsible party
- Principal investigator, Josune Martin Corral, Hospital Galdakao-Usansolo
- Investigators
- Inmaculada Moro, MSc, Principal investigator, Hospital Galdakao-Usansolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483065
- Sponsor's protocol ID
- 2012111139
- Status last verified
- Jun 2015
- First submitted
- 18 Jun 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hospital Admission on Patients With Dementia
- ClinicalTrials.gov ID
- NCT02483065
- Acronym / sponsor ID
- 2012111139
- Conditions
- Dementia
- Keywords
- dementia, hospital admission, mortality, health-related quality of life, activities of daily living
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Collaborators
- Basque Government Department of Public Health
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mortality at discharge and 3-months after the admission in patients with and without dementiaPatients 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. | Other | inpatients with dementia, inpatients without dementia |
Primary outcome
Mortality during hospitalization and at follow-up
Time frame: Up to 3 months
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.
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inmaculada Moro, MSc principal investigator
Hospital Galdakao-Usansolo
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Hospital Galdakao-Usansolo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality during hospitalization and at follow-up (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.