search
Back to results

Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study (OPTICHUTE)

Primary Purpose

Osteoporotic Fractures

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rehabilitation program
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporotic Fractures

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women (age ≥ 60 years)
  • Francophone
  • Hospitalized patient or who is consulted in rheumatology or indicated for bone densitometry in Groupe Hospitalier Paris Saint-Joseph, who are suffered a low-energy osteoporotic fracture in the last 12 months
  • Patient with an acceptable handicap level definied by a Timed Up & Go test (TUG) <14 seconds
  • Autonomous patient with instrumental activities of daily living score (4 items) = 0/4 and Activities of Daily Living score (6 items) ≥5.5/6
  • Patient with medical insurance

Exclusion Criteria:

  • History of locomor specialized care for the falls prevention
  • Cognitive impairment/diagnosed dementia or chronic neurological disorder, which doesn't permit the undertanding or a follow-up to a rehabilitation program
  • Fall due to a neurovascular disease or acute cardiovascular
  • Significant comorbidities which don't permit a locomotor rehabilitation care
  • Refusal to participate in the study
  • Refusal to follow the entire rehabilitation program
  • Geographic remoteness which doesn't permit the movement to the rehabilitation center
  • Contreindicated balneotherapy: incontinence, skin disease or cardiovascular disease
  • Patient under guardianship or curatorship
  • Patient deprived of liberty

Sites / Locations

  • Groupe Hospitalier Paris Saint Joseph

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rehabilitation program

Arm Description

Duration of 8 weeks for a cycle of rehabilitation at the rate of two half-days per week Two interventions per half-day: 30 minutes of education and 1h30 of rehabilitation: physiotherapist, psychomotricity, adapted physical activity

Outcomes

Primary Outcome Measures

Compliance and satisfaction of patients with reinforced medical care
compliance and satisfaction of patients with reinforced medical care: compliance questionnaire. Evaluation made for the end of the program of reeducation : EVALUATION OF PATIENT ATTENDANCE (2 questions): How many days did you participate in re-education sessions at the Hôpital Sainte-Marie Paris as part of the OPTICHUTE rehabilitation program? Have you attended all the proposed rehabilitation sessions? (yes/no) EVALUATION OF PATIENT SATISFACTION: possible answer: degree of satisfaction (very satisfied/overall Satisfied/overall dissatisfied/ very dissatisfied) A: concerning the initial medical examination and the organization of your appointments : 2 questions B: concerning the progress of the reeducation sessions: 5 questions C: concerning the rehabilitation program more generally: 5 questions D: overall assessment - free comment
Satisfaction of health professionals with reinforced medical care: questionnaire.
Satisfaction of health professionals with reinforced medical care: satisfaction questionnaire. Evaluation made for the end of the program of reeducation Sections A and B and D: Hôpital Sainte-Marie Paris staff, Sections C and D: Groupe Hospitalier Paris Saint Joseph staff 12 questions for the sections A-B-C-D with possible answer: degree of satisfaction (very satisfied/rather satisfied/ rather unhappy/ very dissatisfied) A. Regarding the rehabilitation program B. Regarding patients C. Regarding the inclusion visit D: Concerning the link between the rheumatology department of the Groupe Hospitalier Paris Saint Joseph and the hospital day of Rehabilitation of the Hôpital Sainte-Marie Paris E: Overall assessment: ree comment

Secondary Outcome Measures

Number of news falls
Number of new falls within the year following the beginning of the program
Number of new osteoporotic fractures
Number of new osteoporotic fractures within the year following the beginning of the program
Number of new hospitalizations
Number of new hospitalizations within the year following the beginning of the program

Full Information

First Posted
August 8, 2018
Last Updated
April 26, 2023
Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Hôpital Sainte-Marie Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT03642808
Brief Title
Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study
Acronym
OPTICHUTE
Official Title
Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study Based on a Rheumatology-rehabilitation Collaboration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Hôpital Sainte-Marie Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Within the Groupe Hospitalier Paris Saint-Joseph (GHPSJ), a reinforced medical care of osteoporosis ('Fracture Liaison service') was organized for osteoporotic fractured patients. The evaluation of benefits of this program through a randomized study showed an improvement in diagnostic tests performed (bone densitometry) and antiosteoporotic treatment initiated (OPTIPOST study, being published in BMJ). However, of 323 patients included, 91 presented a new fracture within 12 months. Among them, 40/126 patients (31.7%) were in the reinforced medical care arm. This result clearly demonstrates the need for a specific medical care program for patients with osteoporotic fracture falling regularly.
Detailed Description
Only few studies for secondary prevention of falls have been conducted in France yet. This can be partly explained by the complexity of reeducation programs to implement and by organization issues. Moreover, to our knowledge, no study has demonstrated the benefit of such programs on secondary prevention of osteoporotic fractures, even though falls prevention is needed. Our objective is to demonstrate with a pilot study the feasibility of a falls secondary prevention program, based on a rheumatology (GHPSJ) and reeducation wards (Hôpital Sainte-Marie Paris : HSMP) collaboration. Considering the innovative nature of both this program and this collaboration, a feasibility study is preferable before conducting a larger multicentric study, evaluating locomoter benefits of this program in comparison with usual primary care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Fractures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rehabilitation program
Arm Type
Experimental
Arm Description
Duration of 8 weeks for a cycle of rehabilitation at the rate of two half-days per week Two interventions per half-day: 30 minutes of education and 1h30 of rehabilitation: physiotherapist, psychomotricity, adapted physical activity
Intervention Type
Other
Intervention Name(s)
rehabilitation program
Intervention Description
Availibility of patients to complete a rehabilitation program during 8 weeks and to come back 4 times for a careful medical examination
Primary Outcome Measure Information:
Title
Compliance and satisfaction of patients with reinforced medical care
Description
compliance and satisfaction of patients with reinforced medical care: compliance questionnaire. Evaluation made for the end of the program of reeducation : EVALUATION OF PATIENT ATTENDANCE (2 questions): How many days did you participate in re-education sessions at the Hôpital Sainte-Marie Paris as part of the OPTICHUTE rehabilitation program? Have you attended all the proposed rehabilitation sessions? (yes/no) EVALUATION OF PATIENT SATISFACTION: possible answer: degree of satisfaction (very satisfied/overall Satisfied/overall dissatisfied/ very dissatisfied) A: concerning the initial medical examination and the organization of your appointments : 2 questions B: concerning the progress of the reeducation sessions: 5 questions C: concerning the rehabilitation program more generally: 5 questions D: overall assessment - free comment
Time Frame
2 months
Title
Satisfaction of health professionals with reinforced medical care: questionnaire.
Description
Satisfaction of health professionals with reinforced medical care: satisfaction questionnaire. Evaluation made for the end of the program of reeducation Sections A and B and D: Hôpital Sainte-Marie Paris staff, Sections C and D: Groupe Hospitalier Paris Saint Joseph staff 12 questions for the sections A-B-C-D with possible answer: degree of satisfaction (very satisfied/rather satisfied/ rather unhappy/ very dissatisfied) A. Regarding the rehabilitation program B. Regarding patients C. Regarding the inclusion visit D: Concerning the link between the rheumatology department of the Groupe Hospitalier Paris Saint Joseph and the hospital day of Rehabilitation of the Hôpital Sainte-Marie Paris E: Overall assessment: ree comment
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Number of news falls
Description
Number of new falls within the year following the beginning of the program
Time Frame
1 year
Title
Number of new osteoporotic fractures
Description
Number of new osteoporotic fractures within the year following the beginning of the program
Time Frame
1 year
Title
Number of new hospitalizations
Description
Number of new hospitalizations within the year following the beginning of the program
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women (age ≥ 60 years) Francophone Hospitalized patient or who is consulted in rheumatology or indicated for bone densitometry in Groupe Hospitalier Paris Saint-Joseph, who are suffered a low-energy osteoporotic fracture in the last 12 months Patient with an acceptable handicap level definied by a Timed Up & Go test (TUG) <14 seconds Autonomous patient with instrumental activities of daily living score (4 items) = 0/4 and Activities of Daily Living score (6 items) ≥5.5/6 Patient with medical insurance Exclusion Criteria: History of locomor specialized care for the falls prevention Cognitive impairment/diagnosed dementia or chronic neurological disorder, which doesn't permit the undertanding or a follow-up to a rehabilitation program Fall due to a neurovascular disease or acute cardiovascular Significant comorbidities which don't permit a locomotor rehabilitation care Refusal to participate in the study Refusal to follow the entire rehabilitation program Geographic remoteness which doesn't permit the movement to the rehabilitation center Contreindicated balneotherapy: incontinence, skin disease or cardiovascular disease Patient under guardianship or curatorship Patient deprived of liberty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnès PORTIER, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
14600804
Citation
McLellan AR, Gallacher SJ, Fraser M, McQuillian C. The fracture liaison service: success of a program for the evaluation and management of patients with osteoporotic fracture. Osteoporos Int. 2003 Dec;14(12):1028-34. doi: 10.1007/s00198-003-1507-z. Epub 2003 Nov 5.
Results Reference
result
PubMed Identifier
22521109
Citation
Briot K, Cortet B, Thomas T, Audran M, Blain H, Breuil V, Chapuis L, Chapurlat R, Fardellone P, Feron JM, Gauvain JB, Guggenbuhl P, Kolta S, Lespessailles E, Letombe B, Marcelli C, Orcel P, Seret P, Tremollieres F, Roux C. 2012 update of French guidelines for the pharmacological treatment of postmenopausal osteoporosis. Joint Bone Spine. 2012 May;79(3):304-13. doi: 10.1016/j.jbspin.2012.02.014. Epub 2012 Apr 19.
Results Reference
result
PubMed Identifier
2738307
Citation
Campbell AJ, Borrie MJ, Spears GF. Risk factors for falls in a community-based prospective study of people 70 years and older. J Gerontol. 1989 Jul;44(4):M112-7. doi: 10.1093/geronj/44.4.m112.
Results Reference
result
PubMed Identifier
23296743
Citation
Karlsson MK, Magnusson H, von Schewelov T, Rosengren BE. Prevention of falls in the elderly--a review. Osteoporos Int. 2013 Mar;24(3):747-62. doi: 10.1007/s00198-012-2256-7. Epub 2013 Jan 8.
Results Reference
result
PubMed Identifier
28426444
Citation
Briot K. Fracture Liaison Services. Curr Opin Rheumatol. 2017 Jul;29(4):416-421. doi: 10.1097/BOR.0000000000000401.
Results Reference
result
PubMed Identifier
1593914
Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Results Reference
result
PubMed Identifier
5349366
Citation
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
Results Reference
result
PubMed Identifier
14044222
Citation
KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
Results Reference
result
PubMed Identifier
24903196
Citation
Byles JE, Leigh L, Vo K, Forder P, Curryer C. Life space and mental health: a study of older community-dwelling persons in Australia. Aging Ment Health. 2015;19(2):98-106. doi: 10.1080/13607863.2014.917607. Epub 2014 Jun 6.
Results Reference
result
PubMed Identifier
28972994
Citation
Ibrahim A, Singh DKA, Shahar S. 'Timed Up and Go' test: Age, gender and cognitive impairment stratified normative values of older adults. PLoS One. 2017 Oct 3;12(10):e0185641. doi: 10.1371/journal.pone.0185641. eCollection 2017.
Results Reference
result
PubMed Identifier
1202204
Citation
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Results Reference
result

Learn more about this trial

Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study

We'll reach out to this number within 24 hrs