Validity of a Self-administered Questionnaire to Screen Phobia of Falling in the Elderly

Phobic Disorders Clinical Trial

— PACTE-q  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387047
• Other study ID #: 14SDE-PACTEQ
• Status: Completed
• Phase: N/A
• First received: January 27, 2015
• Last updated: November 3, 2015
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Phobic Disorders

Locations

Country	Name	City	State
France	Hôpital Bretonneau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of filled out self-questionnaires	Evaluation of construct validity of the self-questionnaire	1 day	No
Secondary	Item response rate	Evaluation of construct validity of the self-questionnaire	1 day	No
Secondary	Help requirement to fill out the self-questionnaire	Evaluation of construct validity of the self-questionnaire	1 day	No
Secondary	Time to complete the self-questionnaire	Evaluation of construct validity of the self-questionnaire	1 day	No
Secondary	Patients' satisfaction with the self-questionnaire	Evaluation of construct validity of the self-questionnaire	1 day	No
Secondary	Life-space mobility assessed by the Life-Space Assessment		1 day	No
Secondary	Comorbidity assessed by the Cumulative Illness Rating Scale for Geriatrics		1 day	No
Secondary	History of falls, number and gravity		1 day	No
Secondary	Frailty assessment according to phenotype definition of Fried	Evaluation of construct validity of the self-questionnaire	1 day	No
Secondary	The Fear Questionnaire		1 day	Yes
Secondary	The Mobility Inventory for Agoraphobia		1 day	No
Secondary	Fear of falling assessed by the Falls Efficacy Scale-International		1 day	No
Secondary	Self-rated health assessed by the Minimum European Health Module		1 day	No
Secondary	The Timed Up and Go, performance-Oriented Mobility Assessment, 10-m walk test, the 30-s chair-stand test		1 day	No