Patient FallT4HNCT02335177
Technology and Human Help at Home After Hospitalisation
A study testing Interventional arm in people with Patient Fall, run by Ages et Vies Association at 1 site in France.
Trial summary
Elderly people are still at risk for falling at home. The objective of the study is to evaluate at home the impact of an intervention for 3 months combining technologies for autonomy and tailored physical activity program. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Patient Fall
- What is being tested?
- Interventional arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jan 2016
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients hospitalized in Charles Foix Hospital (France) and returning home or already supported by carer of professional home-care service Ages \& Vie
- > 75 years old with loss of autonomy
- at risk for falling
- able to read and understand the information letter and consent letter
- patient requiring physiotherapy and caregiver at home.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology and Human Help at Home After Hospitalisation (T4H): a Randomized Clustered Controlled Trial
Elderly people are still at risk for falling at home. The objective of the study is to evaluate at home the impact of an intervention for 3 months combining technologies for autonomy and tailored physical activity program. The study is performed among patients aged 75 years and over leaving Charles Foix Geriatrics hospital or already supported by carer of professional home-care service Ages \& Vie and with a loss of autonomy requiring physiotherapy and home support workers. It is a prospective, randomized, single-center, in cluster study which compares a Patient group (interventional group) with the intervention program (technologies + physical activities) with a control group benefiting from usual care home. Our hypothesis is that in the interventional group fewer falls were observed and improved different scores (Timed Up and Go Test,Barthel index, Quality of Life questionnaire of Duke) were reported compared to the control group.
- Conditions
- Patient Fall
- Being tested
- Interventional arm
- Keywords
- Falls, Elderly, Physical activities, Technologies for autonomy, Impact of intervention, autonomy, physical activity program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional armBehavioural
At home patients have both technologies for autonomy (walkers, treadmill) and tailored physical activity program performed with the help of the home carer. Intervention takes 3 months. Assessment at hospital discharge et at 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Interventionnal arm | Active comparator | Interventional arm : patients at home with technologies for autonomy and tailored physical activity program. Receives: Behavioral: Interventional arm |
| Control arm | No intervention | Control arm : patients with usual care home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls
absence of fall requiring medical or paramedical care and improvement of the Timed Up and Go Test (TUG) or improvement of the autonomy level assessed by Barthel Index with at least stability of the test that is not improved
Measured: 3 months
Secondary outcomes (3)
Timed up and Go test score
Measured: 3 months
Barthel index
Measured: 3 months
Duke questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionJan 2016
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 Patient FallStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ages et Vies Association
- Sponsor type
- University, hospital or other
- Collaborators
- Caisse Nationale de Solidarité pour l'Autonomie, National Insurance Fund Vieilleisse, Réunica, Fondation Macif
- Responsible party
- Sponsor
- Investigators
- Meziere Anthony, Dr, Principal investigator, Hôpital Charles Foix, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335177
- Sponsor's protocol ID
- 2014-A00579-38
- Acronym
- T4H
- Status last verified
- May 2017
- First submitted
- 7 Jan 2015
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Meziere A, Oubaya N, Michel-Pellegrino V, Boudin B, Neau M, Robert H, Cara I, Salgado Sanchez L, Baloul S, Piette F, Pautas E, Picou Y, Curtis V, Schonheit C, Canoui-Poitrine F, Moreau C. Exercise Interventions With Trained Home Helpers for Preventing Loss of Autonomy and Falls in Community-Dwelling Older Adults Receiving Home Heath Physical Therapy T4H: A Randomized Controlled Pilot Study. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):E138-E149. doi: 10.1519/JPT.0000000000000287.
PubMed 33534333
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology and Human Help at Home After Hospitalisation (T4H): a Randomized Clustered Controlled Trial
- ClinicalTrials.gov ID
- NCT02335177
- Acronym / sponsor ID
- T4H / 2014-A00579-38
- Conditions
- Patient Fall
- Keywords
- Falls, Elderly, Physical activities, Technologies for autonomy, Impact of intervention, autonomy, physical activity program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ages et Vies AssociationUniversity, hospital or other
- Collaborators
- Caisse Nationale de Solidarité pour l'Autonomie, National Insurance Fund Vieilleisse, Réunica, Fondation Macif
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Jan 2015 (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.
Elderly people are still at risk for falling at home. The objective of the study is to evaluate at home the impact of an intervention for 3 months combining technologies for autonomy and tailored physical activity program. The study is performed among patients aged 75 years and over leaving Charles Foix Geriatrics hospital or already supported by carer of professional home-care service Ages \& Vie and with a loss of autonomy requiring physiotherapy and home support workers. It is a prospective, randomized, single-center, in cluster study which compares a Patient group (interventional group) with the intervention program (technologies + physical activities) with a control group benefiting from usual care home. Our hypothesis is that in the interventional group fewer falls were observed and improved different scores (Timed Up and Go Test,Barthel index, Quality of Life questionnaire of Duke) were reported compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventionnal arm | Active comparator | Behavioral: Interventional armInterventional arm : patients at home with technologies for autonomy and tailored physical activity program. |
| Control arm | No intervention | –Control arm : patients with usual care home |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- patients hospitalized in Charles Foix Hospital (France) and returning home or already supported by carer of professional home-care service Ages \& Vie
- > 75 years old with loss of autonomy
- at risk for falling
- able to read and understand the information letter and consent letter
- patient requiring physiotherapy and caregiver at home.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Interventional armAt home patients have both technologies for autonomy (walkers, treadmill) and tailored physical activity program performed with the help of the home carer. Intervention takes 3 months. Assessment at hospital discharge et at 3 months. | Behavioural | Interventionnal arm |
Primary outcome
Number of falls
Time frame: 3 months
absence of fall requiring medical or paramedical care and improvement of the Timed Up and Go Test (TUG) or improvement of the autonomy level assessed by Barthel Index with at least stability of the test that is not improved
3 secondary outcomes
Timed up and Go test score
Time frame: 3 months
Barthel index
Time frame: 3 months
Duke questionnaire
Time frame: 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 30 May 2017.
- Derived from this study: PubMed 33534333Meziere A, Oubaya N, Michel-Pellegrino V, Boudin B, Neau M, Robert H, Cara I, Salgado Sanchez L, Baloul S, Piette F, Pautas E, Picou Y, Curtis V, Schonheit C, Canoui-Poitrine F, Moreau C. Exercise Interventions With Trained Home Helpers for Preventing Loss of Autonomy and Falls in Community-Dwelling Older Adults Receiving Home Heath Physical Therapy T4H: A Randomized Controlled Pilot Study. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):E138-E149. doi: 10.1519/JPT.0000000000000287.
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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.
Meziere Anthony, Dr principal investigator
Hôpital Charles Foix, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional arm in people with Patient Fall, run by Ages et Vies Association at 1 site in France.
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 5 inclusion and 0 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 30 May 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 France. 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?
Number of falls (time frame: 3 months). 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 NCT02335177, 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 30 May 2017.