- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03968536
Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home (KitPA)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ile De France
-
Paris, Ile De France, France, 92100
- Gérond'if
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- In professional activity
- Age < 65 years;
- GIR < 4
- Person under guardianship or curatorship
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of life quality before/after according EQ-ED scale
Time Frame: 6 months
|
Quality of life scale
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assesssment of health status according Self Perceived Health (SPH) scale
Time Frame: 6 months
|
Self Perceived Health (SPH) scale
|
6 months
|
|
Assessment of the impacte of workshops according Likert scale
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frederic Nicolas, master, Gérond'if
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A02910-55
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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