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SALTO - Epidemiological Study on Compliance and Treatment Satisfaction

Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00911001
Acronym
SALTO
Enrollment
480
Registered
2009-06-01
Start date
2008-11-30
Completion date
2009-03-31
Last updated
2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism

Keywords

Arthroplasty, Antithrombotic prophylaxis treatment, Replacement, Knee

Brief summary

Patients that are on total knee/hip replacement initiate prophylaxis treatment on the hospital ground. Once they leave the hospital, as outpatients they continue with the treatment at least during two consecutive weeks. Patients will be instructed to follow treatment recommendations (either LMWH or oral treatment, at physician discretion) and to come back to the surgeon after that period. At that visit, the Treatment Satisfaction Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures compliance with medication) will be answer by the patient. TSQM is an self administered validated scale (validated also in spanish) that measures in a generic way the treatment satisfaction to a treatment. Morinski-Green test will be used to measure the compliance degree on medication.

Interventions

BEHAVIORALNo Drug

Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients in antithrombotic prophylaxis treatment after total knee/hip replacement. This is an epidemiological study where the patients to be included will be those that are treated with antithrombotics as out-patients in real life conditions.

Exclusion criteria

* Patients who has been previously treated with injectable antithrombotic treatments. * Diabetic patients treated with insulin. * Patients who do not sign Informed Consent Form.

Design outcomes

Primary

MeasureTime frame
To measure the Treatment Satisfaction with medication through the self administered scale TSQM.2 weeks

Secondary

MeasureTime frame
To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire2 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026