Early AmbulationNCT01045330
a Modified NTU-HELP Program
A study testing a modified NTU-HELP in people with Early Ambulation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim is to replicate, develop, and pilot test a model of care for the prevention and management of functional decline of older patients during hospitalization. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Early Ambulation
- What is being tested?
- a modified NTU-HELP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2009to Nov 2012
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 year and older
- Length of Stay is over 6 days
- Able to communicate verbally or in writing
Who cannot join
- Coma
- Mechanism ventilation
- Aphasia, if communication ability is severely impaired
- Terminal condition with comfort care only, death imminent
- Combative or dangerous behavior
- Severe psychotic disorder that prevents patient from participating in interventions
Show all 11Show fewer
- Severe dementia (e.g. unable to communicate; MMSE=0). For patients with severe impairment (e.g. MMSE<10), decision to enroll will be made on a case-by-case basis depending on their ability to participate in intervention.
- Respiratory isolation (e.g. tuberculosis). Patients on contact isolation (e.g. vancomycin-resistant enterococcus) or droplet precautions will be enrolled.
- Discharge firmly anticipated within 6 days of admission. Enroll if discharge date unsure
- Refusal by patient or family member.
- Others. Reason to be well documented.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the National Taiwan University Hospital Elder Life Program
The aim is to replicate, develop, and pilot test a model of care for the prevention and management of functional decline of older patients during hospitalization.
Read the detailed description
to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
- Conditions
- Early Ambulation
- Being tested
- a modified NTU-HELP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a modified NTU-HELPBehavioural
The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | Usual care consists of standard hospital services provided by physicians, nurses, and support staff (e.g., physical therapist, dietitian) in the general surgery units. |
| Experimental Group | Experimental | The intervention consisted of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care. Receives: Behavioral: a modified NTU-HELP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status:Barthel Index.
Changes from Baseline Barthel Index (BI) scores at 6 weeks after discharge
Measured: through study completion, an average of 3 months
Mini-Nutritional Assessment scores (MNA)
Changes from Baseline Mini-Nutritional Assessment (MNA) scores at 6 weeks after discharge
Measured: through study completion, an average of 3 months
Mini Mental State Examination scores (MMSE)
Changes from Baseline Mini Mental State Examination (MMSE) scores at 6 weeks after discharge
Measured: through study completion, an average of 3 months
Frailty rates and transition between frailty states
Changes from Baseline Frailty rates at 6 weeks after discharge
Measured: through study completion, an average of 3 months
Postoperative delirium incidence rate [Confusion Assessment Method (CAM)]
Record the incidence of postoperative delirium developing during hospitalization after surgery
Measured: through study completion, an average of 3 months
Postoperative bowel dysmotility
Record the incidence of postoperative bowel dysmotility developing during hospitalization after surgery
Measured: through study completion, an average of 3 months
Secondary outcomes (6)
Body weight
Changes from Baseline Body weight at 6 weeks after discharge
Measured: through study completion, an average of 3 months
Grip strength
Changes from Baseline Grip strength at 6 weeks after discharge
Measured: through study completion, an average of 3 months
Oral health
i.e., plaque index, screens of swallowing function
Measured: through study completion, an average of 3 months
Executive function
ie.e, color trail test
Measured: through study completion, an average of 3 months
Geriatric Depressive Scale scores (GDS)
Changes from Baseline Geriatric Depressive Scale scores (GDS) at 6 weeks after discharge
Measured: through study completion, an average of 3 months
Length of Hospital Stay (LOS)
Record the length of hospital stay for abdominal surgery
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early AmbulationStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Cheryl Chai-Hui Chen, DNSc, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045330
- Sponsor's protocol ID
- 200803077R
- Status last verified
- May 2013
- First submitted
- 8 Jan 2010
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen CC, Li HC, Liang JT, Lai IR, Purnomo JDT, Yang YT, Lin BR, Huang J, Yang CY, Tien YW, Chen CN, Lin MT, Huang GH, Inouye SK. Effect of a Modified Hospital Elder Life Program on Delirium and Length of Hospital Stay in Patients Undergoing Abdominal Surgery: A Cluster Randomized Clinical Trial. JAMA Surg. 2017 Sep 1;152(9):827-834. doi: 10.1001/jamasurg.2017.1083.
PubMed 28538964
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the National Taiwan University Hospital Elder Life Program
- ClinicalTrials.gov ID
- NCT01045330
- Acronym / sponsor ID
- 200803077R
- Conditions
- Early Ambulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, National Science and Technology Council, Taiwan
- Study start
- Aug 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Jan 2010 (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.
The aim is to replicate, develop, and pilot test a model of care for the prevention and management of functional decline of older patients during hospitalization.
Detailed description
to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –Usual care consists of standard hospital services provided by physicians, nurses, and support staff (e.g., physical therapist, dietitian) in the general surgery units. |
| Experimental Group | Experimental | Behavioral: a modified NTU-HELPThe intervention consisted of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 year and older
- Length of Stay is over 6 days
- Able to communicate verbally or in writing
Key exclusion criteria (11 listed)
- Coma
- Mechanism ventilation
- Aphasia, if communication ability is severely impaired
- Terminal condition with comfort care only, death imminent
- Combative or dangerous behavior
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 |
|---|---|---|
| a modified NTU-HELPThe intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care. | Behavioural | Experimental Group |
Primary outcome
Functional status:Barthel Index.
Time frame: through study completion, an average of 3 months
Changes from Baseline Barthel Index (BI) scores at 6 weeks after discharge
Mini-Nutritional Assessment scores (MNA)
Time frame: through study completion, an average of 3 months
Changes from Baseline Mini-Nutritional Assessment (MNA) scores at 6 weeks after discharge
Mini Mental State Examination scores (MMSE)
Time frame: through study completion, an average of 3 months
Changes from Baseline Mini Mental State Examination (MMSE) scores at 6 weeks after discharge
Frailty rates and transition between frailty states
Time frame: through study completion, an average of 3 months
Changes from Baseline Frailty rates at 6 weeks after discharge
Postoperative delirium incidence rate [Confusion Assessment Method (CAM)]
Time frame: through study completion, an average of 3 months
Record the incidence of postoperative delirium developing during hospitalization after surgery
Postoperative bowel dysmotility
Time frame: through study completion, an average of 3 months
Record the incidence of postoperative bowel dysmotility developing during hospitalization after surgery
6 secondary outcomes
Body weight
Time frame: through study completion, an average of 3 months
Grip strength
Time frame: through study completion, an average of 3 months
Oral health
Time frame: through study completion, an average of 3 months
Executive function
Time frame: through study completion, an average of 3 months
Geriatric Depressive Scale scores (GDS)
Time frame: through study completion, an average of 3 months
Length of Hospital Stay (LOS)
Time frame: through study completion, an average of 3 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 6 Oct 2017.
- Derived from this study: PubMed 28538964Chen CC, Li HC, Liang JT, Lai IR, Purnomo JDT, Yang YT, Lin BR, Huang J, Yang CY, Tien YW, Chen CN, Lin MT, Huang GH, Inouye SK. Effect of a Modified Hospital Elder Life Program on Delirium and Length of Hospital Stay in Patients Undergoing Abdominal Surgery: A Cluster Randomized Clinical Trial. JAMA Surg. 2017 Sep 1;152(9):827-834. doi: 10.1001/jamasurg.2017.1083.
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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.
Cheryl Chai-Hui Chen, DNSc principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a modified NTU-HELP in people with Early Ambulation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 11 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 6 Oct 2017. 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 Taiwan. 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?
Functional status:Barthel Index. (time frame: through study completion, an average of 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01045330, which also lists 1 linked publication.
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 6 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.