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AgingPhase 2NCT00038363

Comparison of Subacute and Hospital Based Rehabilitation Care

A Phase 2 study testing Rehabilitation and Subacute care in people with Aging, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed study objective is to compare hospital-based rehabilitative care with transitional subacute rehabilitation for adults recently diagnosed with a disabling disorder. Clinical outcomes, cost and utilization of services will be compared in order to test the hypotheses that medically-stable patients receiving… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aging
What is being tested?
Rehabilitation and Subacute care
Type of treatment
Surgery or procedure
How many people
260 participants
Where
1 siteUnited States
Study dates
Apr 2001to Mar 2004
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Disabling disorders

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Medical Center

    Seattle, Washington

Other trials in United States

About this study

The proposed study objective is to compare hospital-based rehabilitative care with transitional subacute rehabilitation for adults recently diagnosed with a disabling disorder. Clinical outcomes, cost and utilization of services will be compared in order to test the hypotheses that medically-stable patients receiving rehabilitation from subacute care facilities will: 1) function as well physically, 2) report less family dysfunction, 3) have better psychological adjustment and well-being than controls who receive only hospital-based inpatient care, and 4) receive services at lower cost. We intend to assess the impact of hospital-based versus subacute care on clinical and cost outcomes at admission, discharge [3 months post-admission] and at 12 months. The first set of analyses will determine predictors of physical function, family function, psychological adjustment and well-being over a 1 year period.

Read the detailed description

Although subacute transitional care is thought to reduce costs by as much as 60 percent of hospital-based care costs (DHHS, 1995), systematic prospective studies of utilization and cost of services have not been done. An important factor to be considered, particularly in elderly patients, is the cost associated with readmission. Some studies have suggested that cost savings and reduced readmissions are associated with the increased availability of post-discharge services (Ludke, MacDowell, Booth et. al., 1990; Weinberger, Smith, Katz et al., 1988). If such cost savings exist, then transitional subacute care may be an important community-based resource for patients returning to independent living. In addition to demonstrating the clinical efficacy of subacute transitional care, the proposed study will also assess long-term outcomes, taking into account patient resource utilization and the incidence of readmission.

The current study will determine if subacute transitional care can improve outcomes that are important to the broad goals of long term independent living and enhanced quality of life. Variables assessed will focus on physical and family function, adjustment, resource utilization, skilled care placements, and survival. When compared to hospital-based rehabilitation, subacute rehabilitation is expected to demonstrate improvements in physical abilities, family function, adjustment, well being, and survival.

  1. Hypothesis. The primary hypothesis is that clinical outcomes will be significantly better for subacute care patients at 3 and 12 months than hospital-based control patients. Costs and resource utilization are hypothesized to be significantly less.
  2. Objectives and projected timeline. The objective of this study is to conduct a randomized clinical trial to examine the effects of subacute transitional care compared with hospital-based rehabilitative care for disabled patients. Specific objectives will be to: 1] evaluate the type, magnitude and duration of rehabilitative care provided, 2] determine differences in cost of care provided to the two groups, 3] compare clinical outcomes of the two treatments by assessing the magnitude of change, and 4] compare long-term outcomes at 12 months.

Secondary objectives will be to describe diagnostic or demographic subgroups who may benefit to a greater or lesser extent than others.

Patients will be recruited into the study and followed for 1 year, with measurements occurring at hospital admission, at 3 months, and at 12 months. The time to completion of the study is projected to be 3 years. Recruitment of subjects will begin during the second quarter of the project and will continue for 1.5 years. Follow-up measures will continue for an additional year.

Conditions
Aging
Being tested
Rehabilitation, Subacute care
Keywords
Frail, Disable, Disabled Persons, Physically disabled, Elderly, Rehabilitation, Subacute care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationProcedure or surgery

  • Subacute careProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2002 (estimated)
  2. Study startApr 2001
  3. Study completionMar 2004

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00038363
Sponsor's protocol ID
O2571R
Status last verified
May 2002
First submitted
30 May 2002
Last updated
21 Jan 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rehabilitation and Subacute care in people with Aging, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 21 Jan 2009. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

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 21 Jan 2009.

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