Quality of Life Clinical Trial
Official title:
Impact of Telephone Follow-up in Patient's Health-related Quality of Life During the First Six Months of Warfarin Use: Randomized Clinical Trial
Verified date | March 2020 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test an educational program with telephone follow-up to improve health-related quality of life (HRQoL), treatment adherence, and reduce anxiety and depression symptoms in patients who are starting oral anticoagulants (OA).
Status | Completed |
Enrollment | 52 |
Est. completion date | November 30, 2017 |
Est. primary completion date | May 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age over 18 years; - Both genders; - To start the use of Warfarin for the first time during the current hospitalization; - To have a phone. Exclusion Criteria: - To start the Oral Anticoagulation Therapy with another oral anticoagulant; - To start the Warfarin for surgical procedures; - To have visual or hearing impairments; - Don't have cognitive conditions* to answer the questions of data collection instruments (measured by adapted questions from Pfiefer (1975); - To have a cancer diagnosis. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Ribeirao Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Health-Related Quality of Life | The Duke Anticoagulation Satisfaction Scale (DASS) was developed by Samsa et al. (2004) and validated for the Brazilian population by Pelegrino et al. (2011). The scale have 25 items divided in three domains: Limitation (9 items); Hassles and burdens (8 items); Psychological Impacts (8 items). All items have seven response categories: "not at all", "a little", "somewhat", "moderately", "quite a bit", "a lot", and "very much". Possible range: 25 to 175 and lower scores, indicated better Health-Related Quality of Life. | Three and six months after hospital discharge | |
Secondary | Change in Symptoms of Anxiety and Depression | The questionnaire "Hospital Anxiety and Depression Scale (HADS)" was developed by Zigmond and Snaith (1983) and validated and adapted to Portuguese by Botega et al. (1995). The HADS contains 14 multiple choice questions, divided into two subscales: anxiety and depression (composed of seven items each).This questionnaire will be used to collect the data at baseline and at six months. | At baseline, Three and six months after hospital discharge. | |
Secondary | Adherence | Patient adherence to oral anticoagulation therapy will be assessed by the INR (International Normalized Ratio) stability that will be calculated by the percentage of time patients remain within the measurement range using the number of INRs within the therapeutic range, divided by the number of INRs collected. | INR values during the six months follow-up | |
Secondary | Assessment and frequency of adverse events related to Warfarin | Three questions developed by the authors about adverse events related to Warfarin. | Three and six months after hospital discharge |
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