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
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).
Randomized controlled trial (RCT) at two Brazilian public hospitals, one in Ribeirão Preto
and another one in Américo Brasiliense, state of São Paulo, Brazil.
Both groups will receive the educational program (Power Point®Slides, booklets and
orientation) at the hospitalization. After the hospital discharge, the intervention group
will receive the telephone follow-up (five calls for six months: 1st call in one week and the
others calls month by month until six months) and two face to face counseling (1st meeting in
three months and the 2nd meeting in six months). The control group just receive the same face
to face counseling (1st meeting in three months and the 2nd meeting in six months) after the
hospital discharge.
The educational program consist in information about the use of Warfarin and approach the
specific topics in Power Point®Slides: Physiology: Definition of oral anticoagulants,
mechanisms of action and clinical indication; Medication: Dose, time, storage and duration of
therapy; Monitoring: Meaning of International Normalized Ratio (INR) , collection period and
doctor's appointments; Other medications: Drug interactions and those considered "natural";
Feeding: Eating foods rich in K vitamin and fats; Alcoholic beverage: Care about alcohol ,
and if it occurs, does not stop the Oral Anticoagulants; Gestation: Necessity to start IV
anticoagulants; Activities: In physical, domestic or work activities to use protective
measures; Health treatment: Warn about OA to other professional and take the card of INR
values; Travels: On trips take the OA and be programmed to the realization of INR out of
their units; Signs /Symptoms: Report underdose (thrombus formation) and overdose (bleeding),
seek health care.
After the orientations with Power Point®Slides, the patients receive one booklet with the
same informations and the researcher answer any questions that patients have about the
anticoagulation therapy.
In this moment (at hospitalization) the researcher also collects the data about symptoms of
anxiety and depression using the validated questionnaire.
During the telephone calls the researcher talk with the patient about the topics that were
approach in the educational intervention and motivate the patient to follow the
recommendations for they have a successful treatment.
In the face to face counseling (three and six months after hospital discharge) the researcher
collect the data about anxiety and depression again, health-related quality of life and
adverse events related to oral anticoagulation therapy.
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