ElderlyNCT02802358
Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall
An observational study of Elderly and Wrist Fracture, run by Hospital Galdakao-Usansolo.
Trial summary
Objectives: To describe social and health care provided to our older patients who have been admitted in the emergency department (ED) after suffering from a hip or wrist fracture due to a fall. To compare among the different hospitals and town halls, the health and social care that participants received. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly, Wrist Fracture, Hip Fracture
- What is being tested?
- Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)
- Type of treatment
- Surgery or procedure
- How many people
- 1,824 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Sep 2010
- Phase
- Observational
- 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
Study population: Adults aged 65 or older with a hip or wrist fracture due to a fall who attended the ED of the participating hospitals
Who may be able to join
- Hip or wrist fracture due to an accidental fall.
- Providing informed consent.
Who cannot join
- Physical or psychological impairments that would prevent patients from properly completing the questionnaires.
- Syncope.
- No acceptance for taking part in the study.
About this study
Objectives: To describe social and health care provided to our older patients who have been admitted in the emergency department (ED) after suffering from a hip or wrist fracture due to a fall. To compare among the different hospitals and town halls, the health and social care that participants received. To compare the functional dependency and health related quality of life (HRQoL) presented by the patients immediately and six months after a fall.
Methodology: Prospective Cohort study. One hundred and fifty patients suffering from each type of fracture (hip or wrist) will be recruited consecutively in the Basque Health System's participant hospitals sub-project. Within 3 sub-projects, more than 3000 cases are expected to be collected. Data will be collected from ED and hospital clinical records and by means of questionnaires to measure functional dependency (Barthel and Lawton indexes) and HRQoL (SF-36) requesting information on status before the fall, immediately and six months later. In addition to this, data referred to care provided to the patients by traumatologist, rehabilitation or primary care provider as well as social services in their homes after the index episode will be collected.
- Conditions
- Elderly, Wrist Fracture, Hip Fracture
- Being tested
- Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)
- Keywords
- Falls, Functionality
- Medical subject headings
- Wrist Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hip fracture | Patients with a hip fracture due to an accidental fall Receives: Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization) | |
| Wrist fracture | Patients with a wrist fracture due to an accidental fall Receives: Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires to measure change in the functionality of the elderly
Measured: Before and 6 months after the fall
Secondary outcomes (2)
Questionnaire to measure change in the health-related quality of life of the elderly
Measured: Before and 6 months after the fall
Questionnaire to measure change in the performance of activities of daily living
Measured: Before and 6 months after the fall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2009
- Primary completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802358
- Sponsor's protocol ID
- PI08/90417
- Other IDs
- 2008111016
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall
- ClinicalTrials.gov ID
- NCT02802358
- Acronym / sponsor ID
- PI08/90417
- Conditions
- Elderly, Wrist Fracture, Hip Fracture
- Keywords
- Falls, Functionality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,824 participants (actual)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- First posted
- 16 Jun 2016 (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.
Objectives: To describe social and health care provided to our older patients who have been admitted in the emergency department (ED) after suffering from a hip or wrist fracture due to a fall. To compare among the different hospitals and town halls, the health and social care that participants received. To compare the functional dependency and health related quality of life (HRQoL) presented by the patients immediately and six months after a fall.
Methodology: Prospective Cohort study. One hundred and fifty patients suffering from each type of fracture (hip or wrist) will be recruited consecutively in the Basque Health System's participant hospitals sub-project. Within 3 sub-projects, more than 3000 cases are expected to be collected. Data will be collected from ED and hospital clinical records and by means of questionnaires to measure functional dependency (Barthel and Lawton indexes) and HRQoL (SF-36) requesting information on status before the fall, immediately and six months later. In addition to this, data referred to care provided to the patients by traumatologist, rehabilitation or primary care provider as well as social services in their homes after the index episode will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip fracture | – | Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)Patients with a hip fracture due to an accidental fall |
| Wrist fracture | – | Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)Patients with a wrist fracture due to an accidental fall |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults aged 65 or older with a hip or wrist fracture due to a fall who attended the ED of the participating hospitals
Key inclusion criteria (2 listed)
- Hip or wrist fracture due to an accidental fall.
- Providing informed consent.
Key exclusion criteria (3 listed)
- Physical or psychological impairments that would prevent patients from properly completing the questionnaires.
- Syncope.
- No acceptance for taking part in the study.
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 |
|---|---|---|
| Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization) | Procedure or surgery | Hip fracture, Wrist fracture |
Primary outcome
Questionnaires to measure change in the functionality of the elderly
Time frame: Before and 6 months after the fall
2 secondary outcomes
Questionnaire to measure change in the health-related quality of life of the elderly
Time frame: Before and 6 months after the fall
Questionnaire to measure change in the performance of activities of daily living
Time frame: Before and 6 months after the fall
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 16 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly and Wrist Fracture, run by Hospital Galdakao-Usansolo.
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 2 inclusion and 3 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 16 Jun 2016. 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?
Questionnaires to measure change in the functionality of the elderly (time frame: Before and 6 months after the fall). 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 16 Jun 2016.