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Hip ArthroplastyPhase 1/2NCT00226070

Rehabilitation to Patients Over 65 Years Undergoing THA

A Phase 1/2 study testing interview and advising, 3 follow up interviews and personal advising and interview SF-36 self rated health in people with Hip Arthroplasty, run by University of Aarhus at 6 sites in Denmark.

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

Patients over 65 years do not have a self care ability the surgery benefits them. The aim of this study is development of a rehabilitation program based on patients' self-rated health. 1. A cross section study including 600 patients 2. RCT including 160 patients Read more about this study

Who is it for?
Ages 65 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Hip Arthroplasty
What is being tested?
interview and advising, 3 follow up interviews and personal advising and interview SF-36 self rated health
How many people
180 participants
Where
6 sitesDenmark
Study dates
2 Jan 2005to 20 Apr 2010
Phase
Phase 1/2
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 65 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

None listed.

Who cannot join

  • patients dropping out

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Denmark6 sites

  • Aarhus University Hospital

    Aarhus, 8000

  • Kjeld Soballe, Orthopaedic center, University of Aarhus

    Aarhus, 8000

  • Kjeld Soballe, Orthopaedic Center

    Aarhus, 8000

  • Orthopaedic Center

    Aarhus, 8000

  • Ortopaedic center, Aarhus University

    Aarhus, 8000

  • University of Aarhus, Faculty of Health Sciences, Orthopaedic center

    Aarhus, 8000

Other trials in Denmark

About this study

Official title: Cross-section Study Among Patients Waiting for or Already Undergoing THA Followed by a RCT

Patients over 65 years do not have a self care ability the surgery benefits them.

The aim of this study is development of a rehabilitation program based on patients' self-rated health.

  1. A cross section study including 600 patients
  2. RCT including 160 patients
Read the detailed description

Fase 1: 600 patients waiting for or already having received total hip-/knee-replacement participated in a questionnaire study using SF- 36. The aim was to document self-rated health among this population.

Fase 2: Results from the cross section study form the base for the RCT, where 160 patients over 65 years undergoing THR, 80 patients are in an intervention group and 80 patients in a control group. A nurse intervention program is tested, and results from the study will form the base for a structured rehabilitation program.

Being tested
interview and advising, 3 follow up interviews and personal advising, interview SF-36 self rated health
Keywords
selfrated health,, SF-36,, rehabilitation,, total hip replacement,, patients above 65

What participants receive

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

  • interview and advisingProcedure or surgery

  • 3 follow up interviews and personal advisingBehavioural

  • interview SF-36 self rated healthProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Selfrated health among the population shows significant dysfunction among patients over 75 years, patient living alone and patients depended on help from others

Secondary outcomes (2)

  1. undergoing

  2. we know next year

Timeline

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

  1. First posted26 Sep 2005 (estimated)
  2. Study start2 Jan 2005
  3. Primary completion31 Mar 2008
  4. Study completion20 Apr 2010

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 1/2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00226070
Sponsor's protocol ID
1301500110
Other IDs
1999-2-20
Status last verified
Dec 2022
First submitted
23 Sep 2005
Last updated
29 Dec 2022
Results posted
No

Publications

  • Hordam B, Sabroe S, Pedersen PU, Mejdahl S, Soballe K. Nursing intervention by telephone interviews of patients aged over 65 years after total hip replacement improves health status: a randomised clinical trial. Scand J Caring Sci. 2010 Mar;24(1):94-100. doi: 10.1111/j.1471-6712.2009.00691.x. Epub 2009 Apr 28.

    PubMed 19422632

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing interview and advising, 3 follow up interviews and personal advising and interview SF-36 self rated health in people with Hip Arthroplasty, run by University of Aarhus at 6 sites in Denmark.

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 0 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 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Denmark. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

What does the primary outcome measure?

Selfrated health among the population shows significant dysfunction among patients over 75 years, patient living alone and patients depended on help from others. 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 NCT00226070, 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 29 Dec 2022.

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