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Completed

NCT Number: NCT01045330

a Modified NTU-HELP 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.

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Key information

Conditions

Early Ambulation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Unversity Hospital

Taipei, 110, Taiwan

About this study

to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 year and older
  • Length of Stay is over 6 days
  • Able to communicate verbally or in writing

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

a modified NTU-HELP

Behavioral

The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Body weight

    Time frame: through study completion, an average of 3 months

    Changes from Baseline Body weight at 6 weeks after discharge

  2. Grip strength

    Time frame: through study completion, an average of 3 months

    Changes from Baseline Grip strength at 6 weeks after discharge

  3. Oral health

    Time frame: through study completion, an average of 3 months

    i.e., plaque index, screens of swallowing function

  4. Executive function

    Time frame: through study completion, an average of 3 months

    ie.e, color trail test

  5. Geriatric Depressive Scale scores (GDS)

    Time frame: through study completion, an average of 3 months

    Changes from Baseline Geriatric Depressive Scale scores (GDS) at 6 weeks after discharge

  6. Length of Hospital Stay (LOS)

    Time frame: through study completion, an average of 3 months

    Record the length of hospital stay for abdominal surgery

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Health Research Institutes, Taiwan
  • National Science and Technology Council, Taiwan

Registry information

Official study title

Effect of the National Taiwan University Hospital Elder Life Program

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2010
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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