StrokeNCT01706133
An Intervention for Elderly in Emergency Services
A study testing Factors associated with the use of emergency departments in people with Stroke and Ischemic Attack, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
-Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative impacts on the health of elderly over 70 years ? Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Stroke, Ischemic Attack, Diabetes Mellitus
- What is being tested?
- Factors associated with the use of emergency departments
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults 70 and over.
- Both sexes
- Affiliation force in the IMSS
- Attending spontaneously or referred to the emergency department of hospitals in the study.
- Agree to participate in the study phase in observational or intervention by signed written informed consent
Who cannot join
- Adults 70 and older whose income is service by:
- A very serious acute condition with imminent risk to life and requires immediate emergency care, cataloged by the Triage system marked by the IMSS as Red or (state the patient's functional impairment characterized by high and low, with imminent risk life or the integrity and function of some of their organs and requires immediate medical attention since his arrival to the emergency room) or require emergency care (patient condition characterized by acute and severe functional impairment, life-threatening or the integrity and function of some of their organs and requires medical attention within the next 10 minutes after arrival at the emergency department).
- An automobile accident
- Burn-grade II or III
- Partial or total unconsciousness
- Severe cognitive impairment
- Individuals who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elderly in Emergency Services: Effectiveness of an Intervention to Improve Health Outcomes
-Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative impacts on the health of elderly over 70 years ?
Read the detailed description
- Usual care as the comparison group
Usual care or standard refers to those processes or services that the elderly claimant receives the IMSS services network, after the acute phase of their illness has been stabilized and is defined that can be discharged from the emergency department, following clinical and therapeutic recommendations for improving their health.
- Elders risk population for emergency
The aging population brings a major change in health conditions and social conditions around the elderly, the analysis of the elderly population is considered according to functionality and risks of old age, when it comes to care services emergency, care becomes more critical as the elderly are older, have been identified adults of 70 and over as more vulnerable to health services, especially for the emergency services as they do not exhibit classic patterns to acute events of prevalent diseases.
- Functionality and dependence
The commitment of the functionality in adults older than 65 may be present in 5% of cases, while in over 70 years this figure rises to 50% or more. Functional impairment may be a "marker" of the effect of systemic disease on the patient and is also an indicator of severity of disease because it measures the ability of independence
The accumulation of normal aging characteristics define a threshold, which once pierced, tends to increase the propensity for loss of functional abilities due to aging. However, not everyone ages the same way, since factors such as inherited genetic capital, especially the accumulation of risks associated with lifestyle and work activities, and the opportunity to identify the disease in its period latency coupled with the accessibility and use of health services, can delay or exacerbate the loss of functionality and increase the dependency of the elderly.
- Quality of life of older
Frailty in the elderly is a state of increased susceptibility due to less booking multiple physiological systems resulting in lower resilience, negative energy balance, sarcopenia, decreased strength and reduced exercise tolerance. Frailty is associated with adverse health outcomes such as institutionalization, falls, reduced performance status and increased mortality.
- Conditions
- Stroke, Ischemic Attack, Diabetes Mellitus, Hypertension, Fragility
- Being tested
- Factors associated with the use of emergency departments
- Keywords
- Frailty, emergency services, elderly
- Medical subject headings
- Stroke, Diabetes Mellitus, Hypertension, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factors associated with the use of emergency departmentsOther
Participants who were assigned to the intervention will be evaluated jointly by the medical service by a medical specialist in geriatrics and a nurse trained in gerontology and geriatrics. The doctor will monitor the apparition and / or aggravation of any geriatric syndromes already established by the specialty in geriatrics, namely, polypharmacy, delirium, dementia, depression, risk of falls, etc.. The nurse will monitor and follow up in four areas I. medical issues (pressure ulcers, infusion, mobility); II. Mental and emotional state and coping strategies with hospitalization; III. functionality, and IV. Atmosphere (A. Service status, architectural difficulties for mobility, bathing etc. B. Support Network, caregiver, and C. hardship)
| Study group | Role | What they receive |
|---|---|---|
| Basal phase | No intervention | Integrated measurement of all variables involved impact and frequency of prior use of health services and specifically to the emergency room, service access, patient characteristics, features for the classification of frailty, cognitive impairment and depression, why consultation, triage scale level on admission to the service and to the service variables in terms of length of stay, diagnosis and medical management, and related services with internal consultants percentage of inpatients discharged or deceased, in further analysis the researchers undertake group estimating frequency of use and the identification of factors associated with the use of emergency departments and adverse events Receives: Other: Factors associated with the use of emergency departments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hand grip strength (HS) as a physical performance test
A standardized technique and digital dynamometers (Exacta TM) wil lbe used, and the best result of two tests in the dominant hand will be used for analysis. No cut-off points will be applied; instead the variable will be assessed as a continuous one with kilograms as the units of measure.
Measured: Basal and Six months
Secondary outcomes (1)
Evaluation of individual and institutional impact
Evaluate the impact of a scheme based on internal consultation geriatricians and home visiting nurses oriented elders 70 and over, in terms of individual outcomes and health services:
- Individual Impacts: a.1 Primary:
- Fragility
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startJun 2013
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Principal investigator, Maria del Carmen Garcia-Pena, Coordinación de Investigación en Salud, Mexico
- Investigators
- Carmen García-Peña, PhD, Principal investigator, Epidemiological Research Unit and Health Services. XXI Century National Medical CenterSergio Sánchez García, PhD, Study chair, Epidemiological Research Unit and Health Services. XXI Century National Medical CenterTeresa Juarez Cedillo, PhD, Study chair, Epidemiological Research Unit and Health Services. XXI Century National Medical CenterRogelio Moncada Tobias, Doctor, Study chair, Emergency Service. General Hospital Zone No.2Nubia Franco Alvarez, Doctor, Study chair, Internal Medicine. General Hospital Zone No. 2José García González, Master, Study chair, Department of Nephrology. Regional General Hospital No. 1Ulises Pérez Zepeda, Master, Study chair, Institute of GeriatricsLeslie Viridiana Robles Jiménez, Doctor, Study chair, National Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706133
- Sponsor's protocol ID
- R-201 l-785-056
- Status last verified
- Feb 2015
- First submitted
- 10 Oct 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly in Emergency Services: Effectiveness of an Intervention to Improve Health Outcomes
- ClinicalTrials.gov ID
- NCT01706133
- Acronym / sponsor ID
- R-201 l-785-056
- Conditions
- Stroke, Ischemic Attack, Diabetes Mellitus, Hypertension, Fragility
- Keywords
- Frailty, emergency services, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 15 Oct 2012 (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.
-Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative impacts on the health of elderly over 70 years ?
Detailed description
- Usual care as the comparison group
Usual care or standard refers to those processes or services that the elderly claimant receives the IMSS services network, after the acute phase of their illness has been stabilized and is defined that can be discharged from the emergency department, following clinical and therapeutic recommendations for improving their health.
- Elders risk population for emergency
The aging population brings a major change in health conditions and social conditions around the elderly, the analysis of the elderly population is considered according to functionality and risks of old age, when it comes to care services emergency, care becomes more critical as the elderly are older, have been identified adults of 70 and over as more vulnerable to health services, especially for the emergency services as they do not exhibit classic patterns to acute events of prevalent diseases.
- Functionality and dependence
The commitment of the functionality in adults older than 65 may be present in 5% of cases, while in over 70 years this figure rises to 50% or more. Functional impairment may be a "marker" of the effect of systemic disease on the patient and is also an indicator of severity of disease because it measures the ability of independence
The accumulation of normal aging characteristics define a threshold, which once pierced, tends to increase the propensity for loss of functional abilities due to aging. However, not everyone ages the same way, since factors such as inherited genetic capital, especially the accumulation of risks associated with lifestyle and work activities, and the opportunity to identify the disease in its period latency coupled with the accessibility and use of health services, can delay or exacerbate the loss of functionality and increase the dependency of the elderly.
- Quality of life of older
Frailty in the elderly is a state of increased susceptibility due to less booking multiple physiological systems resulting in lower resilience, negative energy balance, sarcopenia, decreased strength and reduced exercise tolerance. Frailty is associated with adverse health outcomes such as institutionalization, falls, reduced performance status and increased mortality.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basal phase | No intervention | Other: Factors associated with the use of emergency departmentsIntegrated measurement of all variables involved impact and frequency of prior use of health services and specifically to the emergency room, service access, patient characteristics, features for the classification of frailty, cognitive impairment and depression, why consultation, triage scale level on admission to the service and to the service variables in terms of length of stay, diagnosis and medical management, and related services with internal consultants percentage of inpatients discharged or deceased, in further analysis the researchers undertake group estimating frequency of use and the identification of factors associated with the use of emergency departments and adverse events |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Adults 70 and over.
- Both sexes
- Affiliation force in the IMSS
- Attending spontaneously or referred to the emergency department of hospitals in the study.
- Agree to participate in the study phase in observational or intervention by signed written informed consent
Key exclusion criteria (7 listed)
- Adults 70 and older whose income is service by:
- Individuals who do not agree to participate in the study
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 |
|---|---|---|
| Factors associated with the use of emergency departmentsParticipants who were assigned to the intervention will be evaluated jointly by the medical service by a medical specialist in geriatrics and a nurse trained in gerontology and geriatrics. The doctor will monitor the apparition and / or aggravation of any geriatric syndromes already established by the specialty in geriatrics, namely, polypharmacy, delirium, dementia, depression, risk of falls, etc.. The nurse will monitor and follow up in four areas I. medical issues (pressure ulcers, infusion, mobility); II. Mental and emotional state and coping strategies with hospitalization; III. functionality, and IV. Atmosphere (A. Service status, architectural difficulties for mobility, bathing etc. B. Support Network, caregiver, and C. hardship) | Other | Basal phase |
Primary outcome
Change in hand grip strength (HS) as a physical performance test
Time frame: Basal and Six months
A standardized technique and digital dynamometers (Exacta TM) wil lbe used, and the best result of two tests in the dominant hand will be used for analysis. No cut-off points will be applied; instead the variable will be assessed as a continuous one with kilograms as the units of measure.
1 secondary outcome
Evaluation of individual and institutional impact
Time frame: Six Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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.
Carmen García-Peña, PhD principal investigator
Epidemiological Research Unit and Health Services. XXI Century National Medical Center
Sergio Sánchez García, PhD study chair
Epidemiological Research Unit and Health Services. XXI Century National Medical Center
Teresa Juarez Cedillo, PhD study chair
Epidemiological Research Unit and Health Services. XXI Century National Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Factors associated with the use of emergency departments in people with Stroke and Ischemic Attack, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in hand grip strength (HS) as a physical performance test (time frame: Basal and Six 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 4 Feb 2015.