Health Services for the AgedNCT04211285
e-GAB: Electronic Geriatric Assessment Bundle: Development of an Arabic Self-administered Android CGA Application
An observational study of Health Services for the Aged and Frailty, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to design and assess the accuracy of administering the electronic Geriatric Assessment Bundle (e-GAB) compared to geriatrician performed comprehensive geriatric assessment (CGA) in a group of Egyptian elderly. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Services for the Aged, Frailty, Cognitive Impairment
- What is being tested?
- e-GAB and standard physician performed CGA
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Jun 2020
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 elderly patients completed the bundle then underwent CGA by an experienced geriatrician blinded to the result of e-GAB
Who may be able to join
- 60 years or above
- community dwelling
- can read and write
- can use the android application
Who cannot join
- any patient refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to design and assess the accuracy of administering the electronic Geriatric Assessment Bundle (e-GAB) compared to geriatrician performed comprehensive geriatric assessment (CGA) in a group of Egyptian elderly. The development of an Arabic software platform for CGA can improve the clinical practice by providing a valid user friendly tool to collect and analyze data for geriatric patients attending non- Geriatric health care service.
Read the detailed description
Modern geriatric care is based primarily on the concept of multidisciplinary approach of elderly care. This could be achieved by integrating CGA in different disciplines dealing with the older patient. CGA is different from that of the standard medical evaluation; it is a systematic evaluation of frail older adults. It uses combinations of validated geriatric tools to formulate an inventory of health problems, and develop an individualized geriatric intervention plan.
The software platform for CGA has been widely used in western countries; however, tools that can fit patients with different backgrounds should be implemented..
From the initial pool of 3 potential subtests, four experienced geriatricians developed a bundle of 15 subtests, to evaluate cognition, mood, vision, hearing, urinary continence, nutrition, functional capacity, fall risk and balance impairment, frailty, polypharmacy, sleep, pain, home safety, and social problems. Moreover, a rapid survey of medical and surgical conditions was obtained.
Initial evaluation of these subsets compared to the reference standard CGA was done. Each patient completed the bundle then underwent CGA by an experienced geriatrician blinded to the result of e-GAB
- Conditions
- Health Services for the Aged, Frailty, Cognitive Impairment, Depression, Disability Physical, Urinary Incontinence
- Being tested
- e-GAB, standard physician performed CGA
- Keywords
- comprehensive geriatric assessment, telemedicine, multidisciplinary approach of elderly care, electronic geriatric assessment bundle
- Medical subject headings
- Frailty, Cognitive Dysfunction, Depression, Urinary Incontinence, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-GABDiagnostic test
android application for comprehensive geriatric assessment
standard physician performed CGADiagnostic test
CGA by an experienced geriatrician blinded to the result of e-GAB
| Study group | Role | What they receive |
|---|---|---|
| community dwelling elderly | community dwelling elderly patients (60 years or older), can read and write, able to use the android software applications Receives: Diagnostic Test: e-GAB; Diagnostic Test: standard physician performed CGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity and specificity of administering the electronic Geriatric Assessment Bundle (e-GAB)
assess sensitivity and specificity of the e-GAB for detecting the aforementioned conditions (e.g. Frailty, Depression, sleep disturbance, malnutrition, cognitive decline etc.. )compared to standard CGA
Measured: the geriatrician will perform standard CGA within 30 minutes of e-GAB completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Aug 2018
- Primary completion15 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services for the AgedStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Rasheedy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211285
- Sponsor's protocol ID
- AinShamsUGer
- Status last verified
- Jan 2021
- First submitted
- 23 Jan 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-GAB: Electronic Geriatric Assessment Bundle: Development of an Arabic Self-administered Android CGA Application
- ClinicalTrials.gov ID
- NCT04211285
- Acronym / sponsor ID
- AinShamsUGer
- Conditions
- Health Services for the Aged, Frailty, Cognitive Impairment, Depression, Disability Physical, Urinary Incontinence
- Keywords
- comprehensive geriatric assessment, telemedicine, multidisciplinary approach of elderly care, electronic geriatric assessment bundle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- 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.
The aim of this study is to design and assess the accuracy of administering the electronic Geriatric Assessment Bundle (e-GAB) compared to geriatrician performed comprehensive geriatric assessment (CGA) in a group of Egyptian elderly. The development of an Arabic software platform for CGA can improve the clinical practice by providing a valid user friendly tool to collect and analyze data for geriatric patients attending non- Geriatric health care service.
Detailed description
Modern geriatric care is based primarily on the concept of multidisciplinary approach of elderly care. This could be achieved by integrating CGA in different disciplines dealing with the older patient. CGA is different from that of the standard medical evaluation; it is a systematic evaluation of frail older adults. It uses combinations of validated geriatric tools to formulate an inventory of health problems, and develop an individualized geriatric intervention plan.
The software platform for CGA has been widely used in western countries; however, tools that can fit patients with different backgrounds should be implemented..
From the initial pool of 3 potential subtests, four experienced geriatricians developed a bundle of 15 subtests, to evaluate cognition, mood, vision, hearing, urinary continence, nutrition, functional capacity, fall risk and balance impairment, frailty, polypharmacy, sleep, pain, home safety, and social problems. Moreover, a rapid survey of medical and surgical conditions was obtained.
Initial evaluation of these subsets compared to the reference standard CGA was done. Each patient completed the bundle then underwent CGA by an experienced geriatrician blinded to the result of e-GAB
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| community dwelling elderly | – | Diagnostic Test: e-GAB, Diagnostic Test: standard physician performed CGAcommunity dwelling elderly patients (60 years or older), can read and write, able to use the android software applications |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 elderly patients completed the bundle then underwent CGA by an experienced geriatrician blinded to the result of e-GAB
Key inclusion criteria (4 listed)
- 60 years or above
- community dwelling
- can read and write
- can use the android application
Key exclusion criteria (1 listed)
- any patient refused to participate
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 |
|---|---|---|
| e-GABandroid application for comprehensive geriatric assessment | Diagnostic test | community dwelling elderly |
| standard physician performed CGACGA by an experienced geriatrician blinded to the result of e-GAB | Diagnostic test | community dwelling elderly |
Primary outcome
the sensitivity and specificity of administering the electronic Geriatric Assessment Bundle (e-GAB)
Time frame: the geriatrician will perform standard CGA within 30 minutes of e-GAB completion
assess sensitivity and specificity of the e-GAB for detecting the aforementioned conditions (e.g. Frailty, Depression, sleep disturbance, malnutrition, cognitive decline etc.. )compared to standard CGA
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 13 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Services for the Aged and Frailty, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 1 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 13 Jan 2021. 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 Egypt. 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?
the sensitivity and specificity of administering the electronic Geriatric Assessment Bundle (e-GAB) (time frame: the geriatrician will perform standard CGA within 30 minutes of e-GAB completion). 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 13 Jan 2021.