FallENCRAGENCT03738709
Occupational Therapy Group Program on Falls Prevention and Patient Education for the Older Adults Hospitalized
A study testing Falls prevention and education giving a demonstration of the usage of technical assistance. in people with Fall, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The primary outcome is to assess the impact of the group program on falls prevention and patient education on home modifications and the implementation of technical assistance. This study aims to demonstrate that a group program on falls prevention and patient education will improve the acceptance and the… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Fall
- What is being tested?
- Falls prevention and education giving a demonstration of the usage of technical assistance.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2018to Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Male/Female over 70 years old living at home and not in a nursing home, hospitalized after a fall or for a falls evaluation.
- Mini mental state examination score over or even 20/30.
- The person is planning to return home after discharge.
Who cannot join
- Decompensated medical pathologies.
- Severe chronical diseases with symptoms that are not stabilized by medical or non-medical treatments.
- Dizziness/vertigo linked to a vestibular or cerebellar disorder.
- Sensory disability preventing communication and participation in the group.
Trial locations and contacts
1 site in 1 country.
Lauriane FISCHER contact
France1 site, 1 recruiting
- Recruiting
Service de Soins de Suite et de Réadaptation Gériatrique - Ergothérapie -Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Stéphanie BETTINELLI, (0)3 88 11 55 51 ext. +33, stephanie.bettinelli@chru-strasbourg.fr
Stéphanie BETTINELLI
About this study
Official title: Occupational Therapy Group Program on Falls Prevention and Patient Education for the Older Adults Hospitalized in Service de Soins de Suite et de Réadaptation Gériatrique (SSRG) at Hôpitaux Universitaires de Strasbourg (HUS)
The primary outcome is to assess the impact of the group program on falls prevention and patient education on home modifications and the implementation of technical assistance.
This study aims to demonstrate that a group program on falls prevention and patient education will improve the acceptance and the implementation of recommendations on technical assistance and home modifications following discharge after an hospitalization for fall.
The secondary outcome will measure the impact of the group program on the incidence of falls, the number of readmissions, fear of another fall and improvement in walking and balance skills.
- Conditions
- Fall
- Being tested
- Falls prevention and education giving a demonstration of the usage of technical assistance.
- Keywords
- Prevention, Group, Technical assistance, Fall, Occupational therapy, Hospitalization discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falls prevention and education giving a demonstration of the usage of technical assistance.Behavioural
Also called Occupational Therapy
- Ecological trail to work on balance and walking.
- Technical assistance presentation and try-outs within the therapeutic apartment.
- Discussion on the perceived feelings over the exercises and the technical assistance submitted.
- Falls Education and prevention, screening of the dangerous activities and education on the safe behaviours.
| Study group | Role | What they receive |
|---|---|---|
| Occupational therapy group sessions | Experimental | In the collective experimental group, the care includes 6 group sessions of one hour each, programmed over 2 weeks and progressive courses. Receives: Behavioral: Falls prevention and education giving a demonstration of the usage of technical assistance. |
| Individual Occupational therapy sessions | Active comparator | In the individual control group, care consists of 6 individual sessions of 45 minutes each, not programmed over 2 weeks and progressive courses. Receives: Behavioral: Falls prevention and education giving a demonstration of the usage of technical assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization.
Measured: 1 month after hospitalization discharge (patient call #1)
Secondary outcomes (8)
Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization.
Measured: 6 months after hospitalization discharge (patient call #2)
Number of falls followed or not by an hospitalization since the discharge.
The number of potential falls in the 6 months after discharge will be measured by a telephone call to the patient (if impossible, the call will be placed to his caregiver or nurse).
Measured: 6 months after the hospitalization discharge (patient call #2)
Fear of falling rate
Fear of falling will be measured by the Falls Efficacy Scale I [FES-I] (score from 16 to 64; higher values represent a stronger fear of falling)
Measured: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of balance skills in daily living activities
Balance skills will be measured by the "Equilibre et Vie Quotidienne" scale: scored from 6 (no danger) to 24 (high risk of fall with impossibility to realize the activities)
Measured: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the walking by the "Stop Walking when Talking" test
Positive test (pathological) if the subject stops walking when the therapist introduces a conversation
Measured: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the motor skills by the Minimum Motor Test
20 items distributed in 4 themes: mobility in decubitus, sitting position, standing position, walking.
Each item rated from 0 (motor skill abnormal) to 1 (motor skill preserved) Total score from 0 to 20; higher values represent preserved motor skills
Measured: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the walking speed by the Timed Up and Go test.
The time of the course (in seconds) is retained as the final score. The test is positive if the score is 14 seconds or more, representing a risk of falling.
Measured: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the number of footsteps in a 10 meters walk, by the Walk test on 10 meters.
The score corresponds to the number of footsteps performed by the subject. Pathological score from 13 footsteps.
Measured: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start4 Dec 2018
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie BETTINELLI, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738709
- Sponsor's protocol ID
- 6790
- Acronym
- ENCRAGE
- Status last verified
- Dec 2018
- First submitted
- 26 Oct 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy Group Program on Falls Prevention and Patient Education for the Older Adults Hospitalized in Service de Soins de Suite et de Réadaptation Gériatrique (SSRG) at Hôpitaux Universitaires de Strasbourg (HUS)
- ClinicalTrials.gov ID
- NCT03738709
- Acronym / sponsor ID
- ENCRAGE / 6790
- Conditions
- Fall
- Keywords
- Prevention, Group, Technical assistance, Fall, Occupational therapy, Hospitalization discharge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 13 Nov 2018 (actual)
- 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 primary outcome is to assess the impact of the group program on falls prevention and patient education on home modifications and the implementation of technical assistance.
This study aims to demonstrate that a group program on falls prevention and patient education will improve the acceptance and the implementation of recommendations on technical assistance and home modifications following discharge after an hospitalization for fall.
The secondary outcome will measure the impact of the group program on the incidence of falls, the number of readmissions, fear of another fall and improvement in walking and balance skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy group sessions | Experimental | Behavioral: Falls prevention and education giving a demonstration of the usage of technical assistance.In the collective experimental group, the care includes 6 group sessions of one hour each, programmed over 2 weeks and progressive courses. |
| Individual Occupational therapy sessions | Active comparator | Behavioral: Falls prevention and education giving a demonstration of the usage of technical assistance.In the individual control group, care consists of 6 individual sessions of 45 minutes each, not programmed over 2 weeks and progressive courses. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male/Female over 70 years old living at home and not in a nursing home, hospitalized after a fall or for a falls evaluation.
- Mini mental state examination score over or even 20/30.
- The person is planning to return home after discharge.
Key exclusion criteria (4 listed)
- Decompensated medical pathologies.
- Severe chronical diseases with symptoms that are not stabilized by medical or non-medical treatments.
- Dizziness/vertigo linked to a vestibular or cerebellar disorder.
- Sensory disability preventing communication and participation in the group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Falls prevention and education giving a demonstration of the usage of technical assistance.Also: Occupational Therapy* Ecological trail to work on balance and walking. * Technical assistance presentation and try-outs within the therapeutic apartment. * Discussion on the perceived feelings over the exercises and the technical assistance submitted. * Falls Education and prevention, screening of the dangerous activities and education on the safe behaviours. | Behavioural | Individual Occupational therapy sessions, Occupational therapy group sessions |
Primary outcome
Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization.
Time frame: 1 month after hospitalization discharge (patient call #1)
8 secondary outcomes
Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization.
Time frame: 6 months after hospitalization discharge (patient call #2)
Number of falls followed or not by an hospitalization since the discharge.
Time frame: 6 months after the hospitalization discharge (patient call #2)
Fear of falling rate
Time frame: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of balance skills in daily living activities
Time frame: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the walking by the "Stop Walking when Talking" test
Time frame: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the motor skills by the Minimum Motor Test
Time frame: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the walking speed by the Timed Up and Go test.
Time frame: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the number of footsteps in a 10 meters walk, by the Walk test on 10 meters.
Time frame: At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Lauriane FISCHER contact
Stéphanie BETTINELLI principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Falls prevention and education giving a demonstration of the usage of technical assistance. in people with Fall, run by University Hospital, Strasbourg, France 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Dec 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie BETTINELLI ((0)3 88 11 55 51 ext. +33, stephanie.bettinelli@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization. (time frame: 1 month after hospitalization discharge (patient call #1)). 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 12 Dec 2018.