Validity of a Self-administered Questionnaire to Screen Phobia of Falling in the Elderly (PACTE-q)

November 3, 2015 updated by: Assistance Publique - Hôpitaux de Paris

Screening for Phobia of Falling in the Elderly: Validity and Feasibility of a Self-administered Questionnaire

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).

Study Overview

Status

Completed

Conditions

Detailed Description

Context : The phobia of falling strongly contributes to the frailty of the elderly, and plays a key role in falls occuring and their deleterious effect. It concerns a big part of seniors living at home, fell before or not, and frequently leads to a restriction of their mobility. When the phobia of falling occurs, the fear of falling down takes an excessive scope, it is associated with anxious reactions when seniors dread the risk, and leads them to avoid these situations reducing their mobility. This reduction of activities contributes to the premature decline of physical capacities, worsens social life, increases the falling and institutionalization risk. However, there is no specific tools for the detection of seniors falling phobia, enabling us to turn patients towards a therapeutic and diagnostical adapted care. A detecting self-questionnaire was thus designed by the research geriatric team after an analysis of the literature and half-directive interviews with a representative sample of the target population.

Objectives : The main objective of this study is to evaluate the validity of a self-questionnaire so as to detect falling phobic seniors living at home. The optimal threshold of the questionnaire score, obtained from a receiver operating characteristic curve (ROC curve), will let us evaluate its concordance compared to the gold standard, formed by DSM-IV criteria for specific phobia. The results of the questionnaire will be kept secret while the study occurs. The secondary objectives will be to control the feasibility of the self-questionnaire detecting phobia of falling, the validity of internal structure and external construction by the exploration of its correlation with other close psychological and physical health measures.

Design : A 1 year prospective monocentric observational study is led with seniors attending geriatric day hospital at the Bretonneau hospital (APHP, Paris). While the same day hospital, all eligible patients will have a current evaluation of cares adapted to their admission causes. These patients will fill out the self-questionnaire detecting phobia, designed by the research geriatric team. The final clinical diagnostic of phobia of falling will be disconfirmed or affirmed from DSM-IV-TR (TR stands for text revision) criteria. At the end of the day hospital, an adapted care to their pathologies will be suggested to all the patients, according to usual practice.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75018
        • Hôpital Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Depression
  • Cognitive disorders
  • Inability to communicate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of the self-questionnaire score compared to the gold standard formed by DSM-IV criteria for specific phobia presence
Time Frame: 1 day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of filled out self-questionnaires
Time Frame: 1 day
Evaluation of construct validity of the self-questionnaire
1 day
Item response rate
Time Frame: 1 day
Evaluation of construct validity of the self-questionnaire
1 day
Help requirement to fill out the self-questionnaire
Time Frame: 1 day
Evaluation of construct validity of the self-questionnaire
1 day
Time to complete the self-questionnaire
Time Frame: 1 day
Evaluation of construct validity of the self-questionnaire
1 day
Patients' satisfaction with the self-questionnaire
Time Frame: 1 day
Evaluation of construct validity of the self-questionnaire
1 day
Life-space mobility assessed by the Life-Space Assessment
Time Frame: 1 day
1 day
Comorbidity assessed by the Cumulative Illness Rating Scale for Geriatrics
Time Frame: 1 day
1 day
History of falls, number and gravity
Time Frame: 1 day
1 day
Frailty assessment according to phenotype definition of Fried
Time Frame: 1 day
Evaluation of construct validity of the self-questionnaire
1 day
The Fear Questionnaire
Time Frame: 1 day
1 day
The Mobility Inventory for Agoraphobia
Time Frame: 1 day
1 day
Fear of falling assessed by the Falls Efficacy Scale-International
Time Frame: 1 day
1 day
Self-rated health assessed by the Minimum European Health Module
Time Frame: 1 day
1 day
The Timed Up and Go, performance-Oriented Mobility Assessment, 10-m walk test, the 30-s chair-stand test
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sandrine DELPIERRE, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14SDE-PACTEQ

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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