FallKitPANCT03968536
Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home
An observational study of Fall and Old Age; Atrophy, run by Gérond'if at 1 site in France.
Trial summary
Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls among People 65 Years Old, Residents at Home in Boulogne city Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Old Age; Atrophy
- What is being tested?
- fall prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2019to 8 Dec 2022
- How long will I take part?
- 3 Months
- 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
- Healthy volunteers accepted
- Older adult
Study population: Autonomous elderly people walking
Who may be able to join
- Retired
- Age ≥ 65 years;
- GIR ≥ 4
- Commitment to participate in all interventions of the "autonomy prevention" Kit
- Autonomous in its travels
- The person expressed no objection to participating in the KitPA study.
Who cannot join
- In professional activity
- Age < 65 years;
- GIR < 4
- Person under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls among People 65 Years Old, Residents at Home in Boulogne city
Read the detailed description
We hypothesize that participation in the multimodal program " Autonomy Prevention Kit " would lead to a decrease in falls and the fear of falling.
this study targets retired people, 65 years of age and over, living at home, identified as being independent (Iso Group Resources type 4-5-6 without formal validation being carried out) but who represent statistically an increased risk of falls in comparison to the general population.
The inclusion takes place before the first session of the Equilibr'Age® workshop. Subjects will have already benefited from a first collective information organized by the Boulogne City Council (see annexes of the CRF). 3 times mark the collection of data.
At the time of inclusion, at the end of the 12 sessions of the Equilbr'Age® workshop (M3) and 3 months after the end of the workshop ( 6 months after the beginning of inclusion).
The study does not involve new acts since it is only an assessment of the effects of a protocol that proposes non-sports activities as well as advice to citizens of the municipality.
- Conditions
- Fall, Old Age; Atrophy
- Being tested
- fall prevention
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fall preventionBehavioural
Also called ergonomics
Training in physiotherapy sessions and ergonomic home development
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the number of falls before/after and the fear of falling before/after according Equilibr'Age® workshop
Equilibr'Age® workshop
Measured: 6 months
Secondary outcomes (1)
Comparison of life quality before/after according EQ-ED scale
Quality of life scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start6 May 2019
- Primary completion3 Oct 2020
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Nicolas, master, Principal investigator, Gérond'if
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968536
- Sponsor's protocol ID
- 2018-A02910-55
- Acronym
- KitPA
- Status last verified
- Jan 2023
- First submitted
- 20 Feb 2019
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home
- ClinicalTrials.gov ID
- NCT03968536
- Acronym / sponsor ID
- KitPA / 2018-A02910-55
- Conditions
- Fall, Old Age; Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 30 May 2019 (actual)
- 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.
Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls among People 65 Years Old, Residents at Home in Boulogne city
Detailed description
We hypothesize that participation in the multimodal program " Autonomy Prevention Kit " would lead to a decrease in falls and the fear of falling.
this study targets retired people, 65 years of age and over, living at home, identified as being independent (Iso Group Resources type 4-5-6 without formal validation being carried out) but who represent statistically an increased risk of falls in comparison to the general population.
The inclusion takes place before the first session of the Equilibr'Age® workshop. Subjects will have already benefited from a first collective information organized by the Boulogne City Council (see annexes of the CRF). 3 times mark the collection of data.
At the time of inclusion, at the end of the 12 sessions of the Equilbr'Age® workshop (M3) and 3 months after the end of the workshop ( 6 months after the beginning of inclusion).
The study does not involve new acts since it is only an assessment of the effects of a protocol that proposes non-sports activities as well as advice to citizens of the municipality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Autonomous elderly people walking
Key inclusion criteria (6 listed)
- Retired
- Age ≥ 65 years;
- GIR ≥ 4
- Commitment to participate in all interventions of the "autonomy prevention" Kit
- Autonomous in its travels
Key exclusion criteria (4 listed)
- In professional activity
- Age < 65 years;
- GIR < 4
- Person under guardianship or curatorship
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 |
|---|---|---|
| fall preventionAlso: ergonomicsTraining in physiotherapy sessions and ergonomic home development | Behavioural | – |
Primary outcome
Comparison of the number of falls before/after and the fear of falling before/after according Equilibr'Age® workshop
Time frame: 6 months
Equilibr'Age® workshop
1 secondary outcome
Comparison of life quality before/after according EQ-ED scale
Time frame: 6 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 13 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Frederic Nicolas, master principal investigator
Gérond'if
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall and Old Age; Atrophy, run by Gérond'if 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 6 inclusion and 4 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 13 Jan 2023. 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?
Comparison of the number of falls before/after and the fear of falling before/after according Equilibr'Age® workshop (time frame: 6 months). 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 13 Jan 2023.