Study of Current Practice Evaluating the Efficacy of a Mobile Short Message Service (SMS) on Post-fracture Management.

NCT ID: NCT01915745

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

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The purpose of the study is to show that the standardized sending of SMS improve the bone mineral density (BMD) screening of patients seen in the Emergency department for low trauma fracture.

Detailed Description

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Osteoporosis is a significant health problem in the older population affecting at least 40% of women and 15 % of men over the age of 50 years. Fracture leads to increased morbidity and mortality and healthcare costs as well as predisposing to future fractures. Patients with a history of low-energy fracture are at significantly increased risk for further fractures in the short-term. There is a universal consensus supported by high-quality randomized trial evidence for secondary prevention: patients with low-trauma fragility fractures should have BMD testing and most of them would benefit from anti-osteoporotic treatment There is, unfortunately, also a well-documented and near-universal gap between evidence-based best practice and usual care for patients with fragility fractures. Although osteoporotic fracture indicates a two- to threefold increased risk of future fracture, only one in five patients receive medical intervention after sustaining an osteoporotic fracture. Diverse post fracture interventions have been developed for improving osteoporosis diagnosis and treatment: provided educational materials to patients and/or primary physician, use of medical reminders, more intensive interventions using osteoporosis case manager (nurse, doctor) and fracture liaison service. the most effective post fracture interventions are those which are more proactive, complex, time consuming, coordinator manager dependant, and costly. Taking account the costs and the humans resources needing, we propose to improve post fracture patient management using mobile telecommunication already used for other chronic diseases management. There is no study about the use of phone short message service (SMS) support in the field of osteoporosis, especially in the post-fracture management: bone mineral density (BMD) screening, anti-osteoporotic treatment initiation and monitoring and improvement of adherence. One of the limitations could be the use of phone mobile in these older patients. We assessed the number of mobile phone users among 100 consecutive subjects who were hospitalized for non vertebral fracture (mean age 69.5 years (50-98); 58 women and 42 men) in the Emergency department of Cochin hospital: 61 % had a mobile phone and used SMS; 61% have a mobile phone.

We propose to assess the efficacy of the use of SMS support to improve the screening and the initiation of antiosteoporotic treatment in patients with low trauma non vertebral fracture, who consult in Emergency department.

This is a study of current care, monocentric, randomized, open. 170 patients will be followed for 6 months. The group control will receive the usual recommendations to make an appointment of realization of bone densitometry. The SMS group will receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting the time of consultation in Emergency department, and will be called during 10 minutes at 6 months by a nurse.

The results of this study will have an important impact for the postfracture management in the field of osteoporosis . Indeed, if we demonstrate that the use of SMS improves the BMD screening and antiosteoporotic treatment initiation, we plan to assess in a large randomized controlled trial whether mobile phone communication can decrease the risk of new fracture comparatively to usual care in patients with low trauma fracture could use.

Conditions

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Low Trauma Non Vertebral Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Usually health care

85 patients receive the usually health care. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated.

Group Type NO_INTERVENTION

No interventions assigned to this group

Short Message Service - SMS

85 patients receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting in the Emergency Department emergencies. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated.

Group Type EXPERIMENTAL

Use of SMS

Intervention Type OTHER

Patients receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting in Emergency Department. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated.

Interventions

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Use of SMS

Patients receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting in Emergency Department. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated.

Intervention Type OTHER

Other Intervention Names

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Sending of 3 SMS to remind to the patient to perform bone densitometry.

Eligibility Criteria

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Inclusion Criteria

* Patients of more than 50 years old
* Low trauma non vertebral fracture
* Ambulatory patient
* Direct access to mobile phone (or access with the help of a close person) and ability to communicate via SMS.
* Patient who doesn't oppose to his participation in the study
* Affiliation to the social security

Exclusion Criteria

* Patients hospitalized for the fracture in the orthopaedics department because these more severe patients have a systematic screening and management of osteoporosis.
* Fractures whose location is not suggestive of osteoporotic fracture (cervical spine, skull, hands, fingers, toes)
* Pathological fractures (cancer or myeloma)
* Traumatic fractures
* Severe alterations of cognitive functions
* Resident subjects except Paris and the surrounding area
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karine BRIOT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cochin Hospital

Locations

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Hospital Cochin

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2012-A01135-38

Identifier Type: OTHER

Identifier Source: secondary_id

K120601

Identifier Type: -

Identifier Source: org_study_id

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