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How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling (PACTE)

Primary Purpose

Specific Phobia, Fear of Falling

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity
Home assessment and modification
Cognitive behavioral therapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia focused on measuring Specific phobia, Fear of Falling, Life-space area

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 70 years of age or older
  • to have a phobia of the fall (according to diagnostic criteria Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) of specific phobia)

Exclusion Criteria:

  • Living in a nursing home
  • Depression (Mini-Geriatric Depression scale score equal 1 or above)
  • Cognitive impairment
  • Medical conditions that would be incompatible or limit compliance with the study requirements
  • Unable to walk even with assistance
  • Patient in a period of exclusion relative to a biomedical study
  • Patient's refusal of participation

Sites / Locations

  • Hôpital Bretonneau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rehabilitation

Rehabilitation and CBT

Arm Description

Rehabilitation : Physical activity Home assessment and modification

Rehabilitation associated with cognitive behavioral therapy (CBT) : Physical activity Home assessment and modification Cognitive behavioral therapy

Outcomes

Primary Outcome Measures

Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 5 months.
For each life-space level (bedroom (score 0), other rooms (1), outside home (2), neighborhood (3), town (4), beyond town (5)), participants were asked how many days a week they attained that level (frequency; <1×/week (score 1), 1-3x/week (2), 4-6x/week (3), daily (4)) and whether they needed help from another person or from assistive devices (assistance; no assistance (score 2), equipment only (1½), personal assistance needed (1)). The LSC ranging from 0 to 120 was calculated based on life-space level *degree of independence in achieving each level * frequency of attaining each level, and then summed for all levels, with higher score representing greater mobility.

Secondary Outcome Measures

Change from baseline in Life-space frequency (a composite score of the Life-Space Assessment which reflects the distance and frequency of movement during the 4 weeks preceding the assessment) at 2, 5 and 8 months.
The life-space frequency ranging from 0 to 60 was calculated based on life-space level score * frequency score at respective level, and then summed, with higher score representing greater mobility.
Change from baseline in Assisted life-space (a score of the Life-Space Assessment which indicating the highest level of life-space attained using the help of assistive devices if needed but not the help of another person) at 2, 5 and 8 months.
The assisted life-space ranging from 0 to 5 was calculated based on life-space level score attained using the help of assistive devices if needed but not the help of another person.
Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 2, 5, 8 months.
For each life-space level (bedroom (score 0), other rooms (1), outside home (2), neighborhood (3), town (4), beyond town (5)), participants were asked how many days a week they attained that level (frequency; <1×/week (score 1), 1-3x/week (2), 4-6x/week (3), daily (4)) and whether they needed help from another person or from assistive devices (assistance; no assistance (score 2), equipment only (1½), personal assistance needed (1)). The LSC ranging from 0 to 120 was calculated based on life-space level *degree of independence in achieving each level * frequency of attaining each level, and then summed for all levels, with higher score representing greater mobility.
Number of falls and injurious falls
Falls were defined as "unintentionally coming to rest on the ground, floor, or other lower level" and collected by face-to-face interview of subjects. Fall events were classified as resulting in "serious" injury if the fall resulted in a fracture, head injuries requiring hospitalisation, joint dislocation, serious sprain, other serious joint injuries, admission to hospital or if any wounds needed stitches (sutures), "moderate" injury if bruising, not serious sprains, cuts, abrasions, or reduction in physical function for at least three days resulted or if the participant sought medical help, and "no" injury.
Fear of falling
Fear of Falling will be measured using the Falls Efficacy Scale-International (FES-I) , a self-report questionnaire of 16 items measuring level of concern about falling during 16 activities of daily living. Minimum score 16, maximum score 64.
Use of anxiolytics drugs in phobic situations related to the phobia of falling
Any change in use of anxiolytics (N05B according to the Anatomical Therapeutic Chemical classification) by participants in phobic situations related to the phobia of falling will be recorded by face-to-face interview.
Self- perceived health
The self-perceived health (SPH) indicator of the Minimum European Health Module is a global measure that encompasses different dimensions of health, i.e. physical, social and emotional function and biomedical signs and symptoms. Self-perceived health appears to be an effective summary of health and has been shown to be a strong predictor of future functional limitations and mortality.

Full Information

First Posted
September 15, 2015
Last Updated
February 15, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02554838
Brief Title
How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling
Acronym
PACTE
Official Title
How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project aims to determine the respective impacts of two routine care regarding phobic of falling seniors on the mobility restriction. The investigators used a monocentric, randomized and controlled research according to two parallel groups : physical activity, home assessment and modification (rehabilitation group) versus physical activity, home assessment and modification with cognitive behavioral therapy (CBT) (rehabilitation and CBT group). The investigators will assess the efficacy of usual care (rehabilitation group) and the supplementary benefit of CBT (rehabilitation and CBT group) with the Life Space Assessment.
Detailed Description
The fear of falling affects about 20% of seniors living at home, having fallen beforehand or not. Its repercussions, like the premature decline of physical capacities, the decrease in quality of life, the loss of independence and the independent risk of falling are well known. They appear mediated by a restriction of mobility when the phobias of falling take place. Indeed, when a phobia of falling occurs, the person limits her moving to avoid the situations confronting her to the object of her fear - in this case, the fall. However, individuals going outdoors less frequently or moving through smaller life-space areas likely have poorer health and function, and coexisting lower levels of physical activity. Thus increasing life-space area may provide important health benefits in elderly people phobic of the fall. The usual cares of the phobia of falling are physical activity, home assessment and modification with or without CBT programs. Their efficacy on the increase in mobility has not been properly assessed. One of the priorities is to assess these programs with some tools reporting improvement in mobility and independence. The Life-Space Assessment (LSA) questionnaire of the Alabama and Birmingham Study of Aging can measure the evolution of the life-space area in an appropriate way, i.e. the spatial area in which a person commonly acts. This 20-item assessment captures the life-space mobility of individuals in five successive areas or life-space (LS) levels (from within the home to outside of town). Subjects are asked the frequency with which they moved in each of the five areas over the past four weeks, and if any assistance (from other persons or with equipment) or no assistance was required. A composite life space score (LSC, range: 0-120) is calculated combining information on the life space level, the degree of independence, and the frequency. Higher scores indicate greater life space. The reliability and construct/criterion validity of this questionnaire translated into French has been published. The purpose of this study is to compare the effectiveness on an aera of mobility, measured using LSC on three months program combinating physical activity, home assessment and modification (rehabilitation group), versus a program combinating physical activity, home assessment and modification, and CBT (rehabilitation and CBT group) of the senior older than 70, suffering from phobia of falling and living at home. After the initial study assessment, each participant will benefit during 8 consecutive weeks of a weekly individual session of physical activity, 2 home-based sessions of modification of the home environment and, moreover, for the patients of the rehabilitation and CBT group, a weekly session of individual CBT during the 8 consecutive weeks of the program and a booster session one month later. Participation in this study will last up to 8 months. LSC will be tested in both groups before, immediately after, 3 and 6 months after completion of the intervention period to explore the benefit of each intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia, Fear of Falling
Keywords
Specific phobia, Fear of Falling, Life-space area

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation
Arm Type
Active Comparator
Arm Description
Rehabilitation : Physical activity Home assessment and modification
Arm Title
Rehabilitation and CBT
Arm Type
Experimental
Arm Description
Rehabilitation associated with cognitive behavioral therapy (CBT) : Physical activity Home assessment and modification Cognitive behavioral therapy
Intervention Type
Other
Intervention Name(s)
Physical activity
Other Intervention Name(s)
Rehabilitation
Intervention Description
Participants receive a weekly individual session of physical activity during 8 consecutive weeks conducted by a licensed physical therapist and focusing on muscle strengthening, flexibility, gait and balance retraining.
Intervention Type
Other
Intervention Name(s)
Home assessment and modification
Other Intervention Name(s)
Home Care Services
Intervention Description
Two home-based sessions of modification of the home environment by a licensed rehabilitation therapist, in order to increase the aera of mobility, the frequency of moving in this aera and the independence to move.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Other Intervention Name(s)
Specific phobia, Fear of Falling, Life-space area
Intervention Description
Participants receive during 8 consecutive weeks a weekly individual sessions of CBT and a booster session one month later conducted by a psychologist specialized in CBT focusing on : functional analysis, education about treatment and anxiety, relaxation training and progressive exposure in imagination then in vivo.
Primary Outcome Measure Information:
Title
Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 5 months.
Description
For each life-space level (bedroom (score 0), other rooms (1), outside home (2), neighborhood (3), town (4), beyond town (5)), participants were asked how many days a week they attained that level (frequency; <1×/week (score 1), 1-3x/week (2), 4-6x/week (3), daily (4)) and whether they needed help from another person or from assistive devices (assistance; no assistance (score 2), equipment only (1½), personal assistance needed (1)). The LSC ranging from 0 to 120 was calculated based on life-space level *degree of independence in achieving each level * frequency of attaining each level, and then summed for all levels, with higher score representing greater mobility.
Time Frame
Baseline, 5 months (3 month follow-up)
Secondary Outcome Measure Information:
Title
Change from baseline in Life-space frequency (a composite score of the Life-Space Assessment which reflects the distance and frequency of movement during the 4 weeks preceding the assessment) at 2, 5 and 8 months.
Description
The life-space frequency ranging from 0 to 60 was calculated based on life-space level score * frequency score at respective level, and then summed, with higher score representing greater mobility.
Time Frame
Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Title
Change from baseline in Assisted life-space (a score of the Life-Space Assessment which indicating the highest level of life-space attained using the help of assistive devices if needed but not the help of another person) at 2, 5 and 8 months.
Description
The assisted life-space ranging from 0 to 5 was calculated based on life-space level score attained using the help of assistive devices if needed but not the help of another person.
Time Frame
Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Title
Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 2, 5, 8 months.
Description
For each life-space level (bedroom (score 0), other rooms (1), outside home (2), neighborhood (3), town (4), beyond town (5)), participants were asked how many days a week they attained that level (frequency; <1×/week (score 1), 1-3x/week (2), 4-6x/week (3), daily (4)) and whether they needed help from another person or from assistive devices (assistance; no assistance (score 2), equipment only (1½), personal assistance needed (1)). The LSC ranging from 0 to 120 was calculated based on life-space level *degree of independence in achieving each level * frequency of attaining each level, and then summed for all levels, with higher score representing greater mobility.
Time Frame
Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Title
Number of falls and injurious falls
Description
Falls were defined as "unintentionally coming to rest on the ground, floor, or other lower level" and collected by face-to-face interview of subjects. Fall events were classified as resulting in "serious" injury if the fall resulted in a fracture, head injuries requiring hospitalisation, joint dislocation, serious sprain, other serious joint injuries, admission to hospital or if any wounds needed stitches (sutures), "moderate" injury if bruising, not serious sprains, cuts, abrasions, or reduction in physical function for at least three days resulted or if the participant sought medical help, and "no" injury.
Time Frame
Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Title
Fear of falling
Description
Fear of Falling will be measured using the Falls Efficacy Scale-International (FES-I) , a self-report questionnaire of 16 items measuring level of concern about falling during 16 activities of daily living. Minimum score 16, maximum score 64.
Time Frame
Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Title
Use of anxiolytics drugs in phobic situations related to the phobia of falling
Description
Any change in use of anxiolytics (N05B according to the Anatomical Therapeutic Chemical classification) by participants in phobic situations related to the phobia of falling will be recorded by face-to-face interview.
Time Frame
Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Title
Self- perceived health
Description
The self-perceived health (SPH) indicator of the Minimum European Health Module is a global measure that encompasses different dimensions of health, i.e. physical, social and emotional function and biomedical signs and symptoms. Self-perceived health appears to be an effective summary of health and has been shown to be a strong predictor of future functional limitations and mortality.
Time Frame
Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 70 years of age or older to have a phobia of the fall (according to diagnostic criteria Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) of specific phobia) Exclusion Criteria: Living in a nursing home Depression (Mini-Geriatric Depression scale score equal 1 or above) Cognitive impairment Medical conditions that would be incompatible or limit compliance with the study requirements Unable to walk even with assistance Patient in a period of exclusion relative to a biomedical study Patient's refusal of participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine DELPIERRE, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bretonneau
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling

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