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

NCT03642808 | Unknown

• 1 other identifier: OPTICHUTE
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Fractures

Outcome Measures

Primary Outcomes (2)

• 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): 1. How many days did you participate in re-education sessions at the Hôpital Sainte-Marie Paris as part of the OPTICHUTE rehabilitation program? 2. 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

  2 months

• 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

  2 months

Secondary Outcomes (3)

• Number of news falls

  1 year

• Number of new osteoporotic fractures

  1 year

• Number of new hospitalizations

  1 year

Study Arms (1)

rehabilitation program

EXPERIMENTAL

* 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

Other: rehabilitation program

Interventions

rehabilitation program OTHER

Availibility of patients to complete a rehabilitation program during 8 weeks and to come back 4 times for a careful medical examination

rehabilitation program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Hôpital Sainte-Marie Paris: collaborator

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (11)

• 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.

  PMID: 14600804 RESULT

• 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.

  PMID: 22521109 RESULT

• 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.

  PMID: 2738307 RESULT

• 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.

  PMID: 23296743 RESULT

• Briot K. Fracture Liaison Services. Curr Opin Rheumatol. 2017 Jul;29(4):416-421. doi: 10.1097/BOR.0000000000000401.

  PMID: 28426444 RESULT

• 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.

  PMID: 1593914 RESULT

• 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.

  PMID: 5349366 RESULT

• 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.

  PMID: 14044222 RESULT

• 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.

  PMID: 24903196 RESULT

• 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.

  PMID: 28972994 RESULT

• 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.

  PMID: 1202204 RESULT

MeSH Terms

Conditions

Osteoporotic Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Agnès PORTIER, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 22, 2018
• Study Start: July 27, 2018
• Primary Completion: November 27, 2019
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)