DepressionNCT03840759
Short-term Effects of an Inpatient Geriatric Consultation Team on Geriatric Syndrome Patients
A study testing inpatient geriatric consultation team in people with Depression and Senile Dementia, run by Chang Gung Memorial Hospital.
Trial summary
Patients admitted to acute ordinary wards in a medical center in Southern Taiwan from an elder-integrated outpatient department or emergency room from January 2017 to December 2017 were included if they met the following criteria: (i) age 65 years or older, (ii) Barthel index score ≦60 and (iii) with at least one of… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Senile Dementia
- What is being tested?
- inpatient geriatric consultation team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2017
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 years or older, (ii) Barthel index (BI) [18] score ≦60 and (iii) with at least one of the following geriatric syndromes: unsteady gait or easy-to-fall ( falls ≧ 2 in last 1 year), malnutrition with Mini Nutritional Assessment-Short Form (MNA®-SF) screening score < 12, urinary incontinence, pressure sores, dementia, delirium, depression, polypharmacy (≧8 medications), and excessive utilization of healthcare facilities (admission≧2, visit Emergency≧2, or visit outpatient department≧12 in one month)-
Who cannot join
- Patients were excluded if they were in a vegetative state, under palliative care or terminally ill and suffering from acute illness needing to be transferred to or cared for in the Intensive Care Unit.
About this study
Official title: A Pilot Study of the Short-term Effects of an Inpatient Geriatric Consultation Team on Geriatric Syndrome Patients
Patients admitted to acute ordinary wards in a medical center in Southern Taiwan from an elder-integrated outpatient department or emergency room from January 2017 to December 2017 were included if they met the following criteria: (i) age 65 years or older, (ii) Barthel index score ≦60 and (iii) with at least one of the following geriatric syndromes: unsteady gait or easy-to-fall ( falls ≧ 2 in last 1 year), malnutrition with Mini Nutritional Assessment-Short Form screening score < 12, urinary incontinence, pressure sores, dementia, delirium, depression, polypharmacy (≧8 medications), and excessive utilization of healthcare facilities (admission≧2, visit Emergency≧2, or visit outpatient department≧12 in one month). Patients were excluded if they were in a vegetative state, under palliative care or terminally ill and suffering from acute illness needing to be transferred to or cared for in the Intensive Care Unit.
Human participant approval was obtained from the Chang Gung Medical Foundation Institutional Review Board before data collection. Participants were recruited from the ordinary wards by research assistants who screened the admission list every morning if they met the inclusion criteria. Then, the detail of the research was explained to the patients and families. They were allowed to choose to be in the control group or the intervention group. After the participants and or family agreed, informed consent was signed. For those who were cognitively impaired or suffered from dementia, informed consent was signed by their relative or partner. For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete geriatric assessment. Besides the geriatric physician, the investigator's multidisciplinary team included a social worker, nutritionist and physical therapist. In the control group, the participants only received routine hospital care and no geriatric physician was consulted.
Read the detailed description
Participants were recruited from the ordinary wards by research assistants who screened the admission list every morning if they met the inclusion criteria. Then, the detail of the research was explained to the patients and families. They were allowed to choose to be in the control group or the intervention group. After the participants and or family agreed, informed consent was signed. For those who were cognitively impaired or suffered from dementia, informed consent was signed by their relative or partner. For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete CGA. The CGA includes the assessment of depression, dementia, physical performance of Activity of Daily Living (ADL) and nutrition using Geriatric Depression Scale (GDC-15), Mini-Mental State Examination (MMSE), Barthel Index (BI), and Mini Nutritional Assessment-Short Form (MNA®-SF) respectively. Besides the geriatric physician, our multidisciplinary team included a social worker, nutritionist and physical therapist. In the control group, the participants only received routine hospital care and no geriatric physician was consulted. The case manager nurse filed the participant's baseline data and clinical problems. After discharge, the participant's condition was assessed via telephone in the first, third and six months after discharge.
- Conditions
- Depression, Senile Dementia
- Being tested
- inpatient geriatric consultation team
- Medical subject headings
- Depression, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient geriatric consultation teamOther
For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete CGA.
| Study group | Role | What they receive |
|---|---|---|
| usual care | Experimental | For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant and inpatient geriatric consultation team after a complete geriatric assessment (CGA). The CGA includes the assessment of depression, dementia, physical performance of Activity of Daily Living (ADL) and nutrition using Geriatric Depression Scale (GDC-15), Mini-Mental State Examination (MMSE), Barthel Index (BI), and Mini Nutritional Assessment-Short Form (MNA®-SF) respectively. Besides the geriatric physician, our multidisciplinary team included a social worker, nutritionist and physical therapist. In the control group, the participants only received routine hospital care and no geriatric physician was consulted. Receives: Other: inpatient geriatric consultation team |
What is being measured
The primary outcome is the main question the study is designed to answer.
readmission rate
compare the differences of readmission rates between the intervention and control groups
Measured: readmission rate within one month after discharge
readmission rate
compare the differences of readmission rates between the intervention and control groups
Measured: readmission rate within three months after discharge
readmission rate
compare the differences of readmission rates between the intervention and control groups
Measured: readmission rate within six months after discharge
Secondary outcomes (3)
mortality rate
compare the differences of mortality rates between the intervention and control groups
Measured: mortality rate within one month after discharge
mortality rate
compare the differences of mortality rates between the intervention and control groups
Measured: mortality rate within three months after discharge
mortality rate
compare the differences of mortality rates between the intervention and control groups
Measured: mortality rate within six months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Song-Seng Loke, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840759
- Sponsor's protocol ID
- CMRPG8F1571
- Status last verified
- Dec 2016
- First submitted
- 30 Jan 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Short-term Effects of an Inpatient Geriatric Consultation Team on Geriatric Syndrome Patients
- ClinicalTrials.gov ID
- NCT03840759
- Acronym / sponsor ID
- CMRPG8F1571
- Conditions
- Depression, Senile Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 Feb 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.
Patients admitted to acute ordinary wards in a medical center in Southern Taiwan from an elder-integrated outpatient department or emergency room from January 2017 to December 2017 were included if they met the following criteria: (i) age 65 years or older, (ii) Barthel index score ≦60 and (iii) with at least one of the following geriatric syndromes: unsteady gait or easy-to-fall ( falls ≧ 2 in last 1 year), malnutrition with Mini Nutritional Assessment-Short Form screening score < 12, urinary incontinence, pressure sores, dementia, delirium, depression, polypharmacy (≧8 medications), and excessive utilization of healthcare facilities (admission≧2, visit Emergency≧2, or visit outpatient department≧12 in one month). Patients were excluded if they were in a vegetative state, under palliative care or terminally ill and suffering from acute illness needing to be transferred to or cared for in the Intensive Care Unit.
Human participant approval was obtained from the Chang Gung Medical Foundation Institutional Review Board before data collection. Participants were recruited from the ordinary wards by research assistants who screened the admission list every morning if they met the inclusion criteria. Then, the detail of the research was explained to the patients and families. They were allowed to choose to be in the control group or the intervention group. After the participants and or family agreed, informed consent was signed. For those who were cognitively impaired or suffered from dementia, informed consent was signed by their relative or partner. For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete geriatric assessment. Besides the geriatric physician, the investigator's multidisciplinary team included a social worker, nutritionist and physical therapist. In the control group, the participants only received routine hospital care and no geriatric physician was consulted.
Detailed description
Participants were recruited from the ordinary wards by research assistants who screened the admission list every morning if they met the inclusion criteria. Then, the detail of the research was explained to the patients and families. They were allowed to choose to be in the control group or the intervention group. After the participants and or family agreed, informed consent was signed. For those who were cognitively impaired or suffered from dementia, informed consent was signed by their relative or partner. For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete CGA. The CGA includes the assessment of depression, dementia, physical performance of Activity of Daily Living (ADL) and nutrition using Geriatric Depression Scale (GDC-15), Mini-Mental State Examination (MMSE), Barthel Index (BI), and Mini Nutritional Assessment-Short Form (MNA®-SF) respectively. Besides the geriatric physician, our multidisciplinary team included a social worker, nutritionist and physical therapist. In the control group, the participants only received routine hospital care and no geriatric physician was consulted. The case manager nurse filed the participant's baseline data and clinical problems. After discharge, the participant's condition was assessed via telephone in the first, third and six months after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| usual care | Experimental | Other: inpatient geriatric consultation teamFor the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant and inpatient geriatric consultation team after a complete geriatric assessment (CGA). The CGA includes the assessment of depression, dementia, physical performance of Activity of Daily Living (ADL) and nutrition using Geriatric Depression Scale (GDC-15), Mini-Mental State Examination (MMSE), Barthel Index (BI), and Mini Nutritional Assessment-Short Form (MNA®-SF) respectively. Besides the geriatric physician, our multidisciplinary team included a social worker, nutritionist and physical therapist. In the control group, the participants only received routine hospital care and no geriatric physician was consulted. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age 65 years or older, (ii) Barthel index (BI) [18] score ≦60 and (iii) with at least one of the following geriatric syndromes: unsteady gait or easy-to-fall ( falls ≧ 2 in last 1 year), malnutrition with Mini Nutritional Assessment-Short Form (MNA®-SF) screening score < 12, urinary incontinence, pressure sores, dementia, delirium, depression, polypharmacy (≧8 medications), and excessive utilization of healthcare facilities (admission≧2, visit Emergency≧2, or visit outpatient department≧12 in one month)-
Key exclusion criteria (1 listed)
- Patients were excluded if they were in a vegetative state, under palliative care or terminally ill and suffering from acute illness needing to be transferred to or cared for in the Intensive Care Unit.
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 |
|---|---|---|
| inpatient geriatric consultation teamFor the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete CGA. | Other | usual care |
Primary outcome
readmission rate
Time frame: readmission rate within one month after discharge
compare the differences of readmission rates between the intervention and control groups
readmission rate
Time frame: readmission rate within three months after discharge
compare the differences of readmission rates between the intervention and control groups
readmission rate
Time frame: readmission rate within six months after discharge
compare the differences of readmission rates between the intervention and control groups
3 secondary outcomes
mortality rate
Time frame: mortality rate within one month after discharge
mortality rate
Time frame: mortality rate within three months after discharge
mortality rate
Time frame: mortality rate within six months after discharge
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 15 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Song-Seng Loke study director
Questions about this trial
What is this clinical trial studying?
A study testing inpatient geriatric consultation team in people with Depression and Senile Dementia, run by Chang Gung Memorial Hospital.
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 1 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 15 Feb 2019. 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?
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?
readmission rate (time frame: readmission rate within one month after discharge). The study lists 3 primary outcomes in all. 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 15 Feb 2019.