Impact of Telephone Follow-up in Patient's Health-related Quality of Life That Use Warfarin
1 other identifier
interventional
52
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Oct 2015
Typical duration for not_applicable quality-of-life
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
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedMarch 30, 2020
March 1, 2020
1.7 years
February 22, 2017
March 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Symptoms of Anxiety and Depression
At baseline, Three and six months after hospital discharge.
Adherence
INR values during the six months follow-up
Assessment and frequency of adverse events related to Warfarin
Three and six months after hospital discharge
Study Arms (2)
Intervention Group
EXPERIMENTALAt 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.
Control Group
ACTIVE COMPARATORAt 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age over 18 years;
- Both genders;
- To start the use of Warfarin for the first time during the current hospitalization;
- To have a phone.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14040902, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rosana S Dantas, PhD
University of São Paulo at Ribeirão Preto College of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 22, 2017
First Posted
April 24, 2017
Study Start
October 1, 2015
Primary Completion
May 30, 2017
Study Completion
November 30, 2017
Last Updated
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share