SALTO - Epidemiological Study on Compliance and Treatment Satisfaction
SALTO
Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism
2 other identifiers
observational
480
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 27, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedSeptember 19, 2013
September 1, 2013
4 months
May 27, 2009
September 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the Treatment Satisfaction with medication through the self administered scale TSQM.
2 weeks
Secondary Outcomes (1)
To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire
2 weeks
Study Arms (1)
Group 1
Interventions
Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.
Eligibility Criteria
Patients in antithrombotic prophylaxis treatment after total knee/hip replacement
You may qualify if:
- 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.
You may not qualify if:
- Patients who has been previously treated with injectable antithrombotic treatments.
- Diabetic patients treated with insulin.
- Patients who do not sign Informed Consent Form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2009
First Posted
June 1, 2009
Study Start
November 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
September 19, 2013
Record last verified: 2013-09