NCT02387047

Brief Summary

The aim of this study is to determine the validity of a self-questionnaire detecting seniors phobia of falling living at home. A prospective monocentric observational study compares in a blind way the presence of Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) criteria for specific phobia, considered as the gold standard to the score obtained at the detecting questionnaire for ≥70 years old seniors suspected of phobia of falling and attending geriatric day hospital at the Bretonneau hospital (APHP, Paris).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 4, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

January 27, 2015

Last Update Submit

November 3, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concordance of the self-questionnaire score compared to the gold standard formed by DSM-IV criteria for specific phobia presence

    In a first time, the optimal threshold of the self-questionnaire score will be determined with a ROC curve. In a second time, this threshold will let us evaluate the score concordance compared to reference method.

    1 day

Secondary Outcomes (14)

  • Percentage of filled out self-questionnaires

    1 day

  • Item response rate

    1 day

  • Help requirement to fill out the self-questionnaire

    1 day

  • Time to complete the self-questionnaire

    1 day

  • Patients' satisfaction with the self-questionnaire

    1 day

  • +9 more secondary outcomes

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients aged 70 years or more, consulting in geriatric day hospital, presenting walking difficulties and/or disturbance of the balance and/or at least one fall during the course of the last 5 years and/or a fear of falling, living in community

You may qualify if:

  • Aged 70 years and over
  • Presenting walking difficulties and/or disturbance of the balance and/or at least one fall during the course of the last 5 years and/or a fear of falling
  • Living in community
  • Non opposition of the patient to the collection of his personal data

You may not qualify if:

  • Depression
  • Cognitive disorders
  • Inability to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bretonneau

Paris, 75018, France

Location

MeSH Terms

Conditions

Phobic Disorders

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Sandrine Delpierre, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

March 12, 2015

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-10

Locations