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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03968536
Other study ID # 2018-A02910-55
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 6, 2019
Est. completion date December 8, 2022

Study information

Verified date January 2023
Source Gérond'if
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date December 8, 2022
Est. primary completion date October 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
fall prevention
Training in physiotherapy sessions and ergonomic home development

Locations

Country Name City State
France Gerond'if Paris Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Assesssment of health status according Self Perceived Health (SPH) scale Self Perceived Health (SPH) scale 6 months
Other Assessment of the impacte of workshops according Likert scale 6 months
Primary Comparison of the number of falls before/after and the fear of falling before/after according Equilibr'Age® workshop Equilibr'Age® workshop 6 months
Secondary Comparison of life quality before/after according EQ-ED scale Quality of life scale 6 months
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