Specific Phobia Clinical Trial
— PACTEOfficial title:
How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling
Verified date | February 2023 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | November 2019 |
Est. primary completion date | May 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Bretonneau | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 5 months (3 month follow-up) | |
Secondary | 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. | Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up) | |
Secondary | 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. | Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up) | |
Secondary | 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. | Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up) | |
Secondary | 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. |
Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up) | |
Secondary | 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. | Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up) | |
Secondary | 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. | Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up) | |
Secondary | 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. | Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up) |
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