Phobic DisordersPACTE-qNCT02387047
Validity of a Self-administered Questionnaire to Screen Phobia of Falling in the Elderly
An observational study of Phobic Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Phobic Disorders
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- Depression
- Cognitive disorders
- Inability to communicate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Phobic Disorders
- Medical subject headings
- Phobic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (14)
Percentage of filled out self-questionnaires
Evaluation of construct validity of the self-questionnaire
Measured: 1 day
Item response rate
Evaluation of construct validity of the self-questionnaire
Measured: 1 day
Help requirement to fill out the self-questionnaire
Evaluation of construct validity of the self-questionnaire
Measured: 1 day
Time to complete the self-questionnaire
Evaluation of construct validity of the self-questionnaire
Measured: 1 day
Patients' satisfaction with the self-questionnaire
Evaluation of construct validity of the self-questionnaire
Measured: 1 day
Life-space mobility assessed by the Life-Space Assessment
Measured: 1 day
Comorbidity assessed by the Cumulative Illness Rating Scale for Geriatrics
Measured: 1 day
History of falls, number and gravity
Measured: 1 day
Frailty assessment according to phenotype definition of Fried
Evaluation of construct validity of the self-questionnaire
Measured: 1 day
The Fear Questionnaire
Measured: 1 day
The Mobility Inventory for Agoraphobia
Measured: 1 day
Fear of falling assessed by the Falls Efficacy Scale-International
Measured: 1 day
Self-rated health assessed by the Minimum European Health Module
Measured: 1 day
The Timed Up and Go, performance-Oriented Mobility Assessment, 10-m walk test, the 30-s chair-stand test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobic DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine Delpierre, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387047
- Sponsor's protocol ID
- 14SDE-PACTEQ
- Acronym
- PACTE-q
- Status last verified
- Oct 2015
- First submitted
- 27 Jan 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Phobia of Falling in the Elderly: Validity and Feasibility of a Self-administered Questionnaire
- ClinicalTrials.gov ID
- NCT02387047
- Acronym / sponsor ID
- PACTE-q / 14SDE-PACTEQ
- Conditions
- Phobic Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Depression
- Cognitive disorders
- Inability to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
14 secondary outcomes
Percentage of filled out self-questionnaires
Time frame: 1 day
Item response rate
Time frame: 1 day
Help requirement to fill out the self-questionnaire
Time frame: 1 day
Time to complete the self-questionnaire
Time frame: 1 day
Patients' satisfaction with the self-questionnaire
Time frame: 1 day
Life-space mobility assessed by the Life-Space Assessment
Time frame: 1 day
Comorbidity assessed by the Cumulative Illness Rating Scale for Geriatrics
Time frame: 1 day
History of falls, number and gravity
Time frame: 1 day
Frailty assessment according to phenotype definition of Fried
Time frame: 1 day
The Fear Questionnaire
Time frame: 1 day
The Mobility Inventory for Agoraphobia
Time frame: 1 day
Fear of falling assessed by the Falls Efficacy Scale-International
Time frame: 1 day
Self-rated health assessed by the Minimum European Health Module
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine Delpierre, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phobic Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of the self-questionnaire score compared to the gold standard formed by DSM-IV criteria for specific phobia presence (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.