Clinical trial NCT03125668: Impact of Telephone Follow-up in Patient's Health-related Quality of Life That Use Warfarin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Warfarin
Health Education
Patient Compliance
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Health-Related Quality of Life
timeFrame: Three and six months after hospital discharge
Secondary outcomes:
measure: Change in Symptoms of Anxiety and Depression
timeFrame: At baseline, Three and six months after hospital discharge.
measure: Adherence
timeFrame: INR values during the six months follow-up
measure: Assessment and frequency of adverse events related to Warfarin
timeFrame: Three and six months after hospital discharge
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Rosana S Dantas, PhD
role: STUDY_CHAIR
References: