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Completed

NCT Number: NCT02387047

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

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).

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Bretonneau

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of filled out self-questionnaires

    Time frame: 1 day

    Evaluation of construct validity of the self-questionnaire

  2. Item response rate

    Time frame: 1 day

    Evaluation of construct validity of the self-questionnaire

  3. Help requirement to fill out the self-questionnaire

    Time frame: 1 day

    Evaluation of construct validity of the self-questionnaire

  4. Time to complete the self-questionnaire

    Time frame: 1 day

    Evaluation of construct validity of the self-questionnaire

  5. Patients' satisfaction with the self-questionnaire

    Time frame: 1 day

    Evaluation of construct validity of the self-questionnaire

  6. Life-space mobility assessed by the Life-Space Assessment

    Time frame: 1 day

  7. Comorbidity assessed by the Cumulative Illness Rating Scale for Geriatrics

    Time frame: 1 day

  8. History of falls, number and gravity

    Time frame: 1 day

  9. Frailty assessment according to phenotype definition of Fried

    Time frame: 1 day

    Evaluation of construct validity of the self-questionnaire

  10. The Fear Questionnaire

    Time frame: 1 day

  11. The Mobility Inventory for Agoraphobia

    Time frame: 1 day

  12. Fear of falling assessed by the Falls Efficacy Scale-International

    Time frame: 1 day

  13. Self-rated health assessed by the Minimum European Health Module

    Time frame: 1 day

  14. The Timed Up and Go, performance-Oriented Mobility Assessment, 10-m walk test, the 30-s chair-stand test

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PACTE-q

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2015
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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