Impact of Telephone Follow-up in Patient's Health-related Quality of Life During the First Six Months of Warfarin Use: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Health-Related Quality of Life
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years;
- •Both genders;
- •To start the use of Warfarin for the first time during the current hospitalization;
- •To have a phone.
排除标准
- •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.
结局指标
主要结局
Change in Health-Related Quality of Life
时间窗: 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.
次要结局
- 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)
- Change in Symptoms of Anxiety and Depression(At baseline, Three and six months after hospital discharge.)
研究者
Rafaela de Oliveira Manzato
Principal Investigator
University of Sao Paulo