Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 主要终点
- Percentage of Participants Adherent to Treatment at Month 6
研究概览
简要总结
The overall purpose of the study was to describe the real-life adherence, effectiveness and safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r; Kaletra®) in Canada.
详细描述
The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events. Patients enrolled in KASA may also have access to various healthcare professionals (dietician, social worker, psychologist, etc.) or may be offered other types of support (transportation, exercise, etc.), which may help improve their quality of life as well as adherence or compliance while taking LPV/r.
This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. All treatments including participation in the KASA program were according to the decision of the treating physician and the patients and were not affected in any way by their decision to participate in the study. Follow-up was for 12 months at an interval of every six months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is HIV-positive
- •On treatment with LPV/r or currently initiated on treatment with LPV/r.
- •Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
- •Willing to be enrolled in the Kaletra Adherence Support Assistance (KASA) program.
- •Prescribed LPV/r as part of his/her treatment by the treating physician.
排除标准
- •Not willing to sign an informed consent.
- •In the opinion of the treating physician is unlikely to be available for the 12-month follow-up duration of the study.
- •Is currently participating in a clinical trial of an investigational product.
- •Not willing to participate in the KASA program.
研究组 & 干预措施
Lopinavir/Ritonavir + KASA
Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
干预措施: Lopinavir / ritonavir (Drug)
Lopinavir/Ritonavir + KASA
Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
干预措施: Kaletra Adherence Support Assistance Program (Behavioral)
结局指标
主要结局
Percentage of Participants Adherent to Treatment at Month 6
时间窗: Baseline and 6 months
Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.
次要结局
- Change From Baseline in Adherence Summative Score at Months 6 and 12(Baseline, Month 6 and Month 12)
- Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12(Baseline, Month 6 and Month 12)
- Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12(Baseline, Month 6 and Month 12)
- Percentage of Participants Adherent to Treatment at Month 12(Baseline and 12 months)
- Change From Baseline in Health-related Quality of Life General Health Perception Domain Score(Baseline, Month 6 and Month 12)
- Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score(Baseline, Month 6 and Month 12)
- Change From Baseline in Health-related Quality of Life Role Functioning Domain Score(Baseline, Month 6 and Month 12)
- Change From Baseline in Health-related Quality of Life Social Functioning Domain Score(Baseline, Month 6 and Month 12)
- Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score(Baseline, Month 6 and Month 12)
- Change From Baseline in Health-related Quality of Life Pain Domain Score(Baseline, Month 6 and Month 12)
- Change From Baseline in Health-related Quality of Life Mental Health Domain Score(Baseline, Month 6 and Month 12)
- Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score(Baseline, Month 6 and Month 12)
- Change From Baseline in Patient Perception of Stress(Baseline, Month 6 and Month 12)
- Change From Baseline in Psychological Well-being(Baseline, Month 6 and Month 12)
- Change From Baseline in Coping Self-Efficacy(Baseline, Month 6 and Month 12)
- Health Resource Utilization(Baseline, Month 6 and Month 12)
- Viral Load at Each Visit(Baseline, Month 6 and Month 12)
- Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit(Baseline, Month 6 and Month 12)
- Healthcare Provider Satisfaction(Month 6 and Month 12)