KitPA: Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home

Sponsor

Gérond'if (Other)

Overall Status

Unknown status

CT.gov ID

NCT03968536

Collaborator

(none)

Enrollment

Location

14.9

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls among People 65 Years Old, Residents at Home in Boulogne city

Condition or Disease	Intervention/Treatment	Phase
Fall Old Age; Atrophy	Behavioral: fall prevention

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

64 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home

Actual Study Start Date :

May 6, 2019

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Outcome Measures

Primary Outcome Measures

Comparison of the number of falls before/after and the fear of falling before/after according Equilibr'Age® workshop [6 months]
Equilibr'Age® workshop

Secondary Outcome Measures

Comparison of life quality before/after according EQ-ED scale [6 months]
Quality of life scale

Other Outcome Measures

Assesssment of health status according Self Perceived Health (SPH) scale [6 months]
Self Perceived Health (SPH) scale
Assessment of the impacte of workshops according Likert scale [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gerond'if	Paris	Ile De France	France	92100

Sponsors and Collaborators

Gérond'if

Investigators

Principal Investigator: Frederic Nicolas, master, Gérond'if

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gérond'if

ClinicalTrials.gov Identifier:

NCT03968536

Other Study ID Numbers:

CPP 72/18_3 n° 18.11.09.41316

First Posted:

May 30, 2019

Last Update Posted:

Apr 27, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrophy

Study Results

No Results Posted as of Apr 27, 2020