- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387047
Validity of a Self-administered Questionnaire to Screen Phobia of Falling in the Elderly (PACTE-q)
Screening for Phobia of Falling in the Elderly: Validity and Feasibility of a Self-administered Questionnaire
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Paris, France, 75018
- Hôpital Bretonneau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Sandrine DELPIERRE, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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