- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125668
Impact of Telephone Follow-up in Patient's Health-related Quality of Life That Use Warfarin
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Ribeirao Preto, São Paulo, Brazil, 14040902
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
At the hospitalization, patients receive the educational program (Power Point®Slides, booklets and orientation) about the use of warfarin.
After hospital discharge they receive a telephone follow-up (five calls) and two Face to face counseling.
|
At the hospitalization, patients receive the educational program with Power Point®Slides, booklets and orientation about the use of warfarin.
After hospital discharge they receive a telephone follow-up (five calls for six months: 1st call in one week and the others calls month by month until six months). 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.
They receive two face to face counseling (1st meeting in three months and the 2nd meeting in six months after hospital discharge).
In the face to face counseling the researcher collect the data about anxiety and depression again, health-related quality of life and adverse events related to oral anticoagulation therapy.
|
Active Comparator: Control Group
At the hospitalization, patients receive the educational program (Power Point®Slides, booklets and orientation) about the use of warfarin.
After hospital discharge they receive two face to face counseling.
|
At the hospitalization, patients receive the educational program with Power Point®Slides, booklets and orientation about the use of warfarin.
They receive two face to face counseling (1st meeting in three months and the 2nd meeting in six months after hospital discharge).
In the face to face counseling the researcher collect the data about anxiety and depression again, health-related quality of life and adverse events related to oral anticoagulation therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health-Related Quality of Life
Time Frame: Three and six months after hospital discharge
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Symptoms of Anxiety and Depression
Time Frame: At baseline, Three and six months after hospital discharge.
|
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.
|
Adherence
Time Frame: INR values during the six months follow-up
|
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
|
Assessment and frequency of adverse events related to Warfarin
Time Frame: Three and six months after hospital discharge
|
Three questions developed by the authors about adverse events related to Warfarin.
|
Three and six months after hospital discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Rosana S Dantas, PhD, University of São Paulo at Ribeirão Preto College of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 38736914.1.0000.5393
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
Clinical Trials on Educational Program
-
Norwegian University of Science and TechnologyCompletedFecal Incontinence | Staffs' AttitudesNorway
-
Universidade Nova de LisboaCompletedAnxiety | Prescription Drug Abuse and DependencyPortugal
-
Medical University of GrazCompleted
-
Universitaire Ziekenhuizen KU LeuvenFund for Scientific Research, Flanders, BelgiumCompletedPain | Breast NeoplasmBelgium
-
University of BarcelonaFundació La Marató de TV3; SHE Foundation; Centro Nacional de Investigaciones... and other collaboratorsActive, not recruitingObesity | Diabetes Mellitus | Cardiovascular HealthSpain
-
Cairo UniversityUnknown
-
National Center for Research Resources (NCRR)Virginia Commonwealth UniversityCompletedSystemic Lupus Erythematosus
-
The University of Texas Health Science Center at...National Heart, Lung, and Blood Institute (NHLBI)Completed
-
Weill Medical College of Cornell UniversityDoris Duke Charitable FoundationNot yet recruiting
-
Clinica Alemana de SantiagoNot yet recruiting