Exploration of the Medication Disturbance, Quality of Life and Effectiveness of an Educational Program on the up to Six Months Follow-Up in Atrial Fibrillation Patients Under Warfarin Treatment

Purpose:

Purposes of this study were to (A) assess the medication disturbance and QoL of AF patients taking Warfarin, and to (B) evaluate patients’ cognition of medication, compliance to medical treatment, INR (international normalized ratio) values , bleeding side effect, thrombosis or stroke after individual education on Warfarin implemented by nurses.

Methods:

A total of 122 AF patients with Warfarin treatment were recruited from the outpatients in a medical center, Taiwan. They received the baseline assessment of INR, medication knowledge and disturbance, medicine compliance and QoL by laboratory data and questionnaire when they signed up the informed consent. Based on these results, they were divided into 3 groups. Group 1 (standard group, n=15) was patients showed an understanding of how to take Warfarin safely and had good compliance of the medicine. For them, no intervention was implemented. The other participants with limited understanding and poor compliance were divided into group 2 (control group, n=48) and 3 (experimental group, n=59) randomly. The control group received routine care whereas the experimental group received the personal education program. All these 3 groups received 6 months’ follow-up assessments in order to identify the effectiveness of the educational program. Finally, only 113 participants completed the 6 months’ follow up (group 1=15; group 2=45; group 3=53).Outcome indicators included: medication knowledge, compliance to medical treatment, INR values, leading side effect, thrombosis or stroke was carried out at the third and sixth month. The post-test at the sixth month were accomplished for medication disturbances and SF-36-QoL among these 3 groups.

SPSSPC-Win18.0 was used for statistics analysis. Descriptive statistics included mean, standard deviation, frequency and percentage. Inferential statistics including unpaired t test, two-way analysis of variance (ANOVA), Chi-Square test, and Fisher’s exact test were used to compare the differences between groups; paired t test and McNemar’s test were used to compare pre-test and post-test within 3 groups. Multiple regression was used for predicting the significant factors of participants’ QoL. The significant level of this study was 0.05.

Results:

The mean age of whole participants was 69.7 years old (SD=12, range: 38-95). Most of the participants were male (51.6%), married (68%), diagnosed as AF more than one year (89.3%) and take Warfarin more than 1 years (74%). In addition, no significant differences of demographic data and medical conditions existed between experimental and control groups. In regard to the INR value, there is no significant difference between the first assessment and the 6 month’s follow for both the experimental and control groups. However, 2 participants experienced stroke and 4 cases experienced bleeding side effects during study period.

For the experimental group, the levels of anticoagulant knowledge and medication compliance were increased from 5.7±1.2 (first assessment) to 6.8±1.4 (3- month, t=-6.1; p=0.000) and 6.6±1.6 (6-momth, t=-3.9; p<.001). Significant improvements were found in the single items as “observing the symptoms or signs of abnormal bleeding”, “purpose of taking anticoagulant” and “medication precautions”. When comparing 3 groups, we found that the highest knowledge score of anticoagulant was the standard group, but there was no significant difference between experimental and control group both in the first assessment and post-test. Overall, the lowest score items of anticoagulant knowledge were “diet adjustment “and “medication precautions” both in pre-test and post-test.

When “disturbances of anticoagulant” as an issue in the experimental group, the levels significantly increased from 0.9±1.1 (first assessment) to 1.7±1.9 (6-momth, t=-1.74; p=0.01) in experimental group. In addition, most patients worry about ” incidence of stroke or thrombus” and “frequent blood test” in first assessment. However, more participants worried about “medication side effects” in 6-month follow-up. As for QoL, in first assessment, participants in experimental group reported their ranges of QoL were 58 to 83, where “role restriction due to physical problems”, “general health” and “vitality “ were the worst ones reported. When compared with the first assessment, participants reported significantly decreased “social function” (t=2.0, p=0.046) and “mental health” (t=3.9, p=0.00). Additionally, age, gender, married status, education level, stroke, congestive heart failure, past surgery, comorbidity, bleeding experience and medication disturbances affected participants’ subgroup QoL in the first assessmen among 122 AF patients who were taking Warfarin.

Conclusion: The personalized education program could improve the levels of anticoagulant knowledge and medication compliance. However, we still recommend enhancing the subjects of health education over “diet adjustment” and “avoiding medication interaction “among AF patients who are taking Warfarin. We require balancing the effectiveness of health education without causing patients to excessively worry about medication. Otherwise, patients’ QoL is a complicated and important issue. The effectiveness of educational intervention in patients’ QoL is a subjective outcome indicator. The relationships between education intervention, medication disturbances, or other factors and patients’ QoL could be explored in advance. Thus, finding out how to improve real QoL of AF patients’ under Warfarin treatment by increasing their medication knowledge and decreasing medication disturbances are our ultimate goals.