跳至主要内容
临床试验/NCT04319029
NCT04319029已完成不适用

Assessment of Patients' Knowledge, Quality of Life, and Adherence for Medication in Dyslipidemia - a Randomized Interventional Study

Al-Rasheed University College2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Change in the medication adherence in intervention group vs. non-intervention group

研究概览

简要总结

A randomized, parallel two-arm interventional study, the patients were divided into 1:1 ratio, in which both groups offered optimal pharmacological therapy also one group (interventional) offered predesign pharmaceutical care plan aimed to improved patients knowledge, adherence, satisfaction, and quality of life, while the other group (non-interventional) received conventional pharmaceutical care plan.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with dyslipidemia and received at least one statin therapy (in the previous 6 months), and patients on the same class of pharmacological therapy (statins).

排除标准

  • Pregnant women
  • Nephrotic syndrome
  • Active steroid user
  • Hypersensitivity for any mediation during the trial
  • History of a major cardiovascular event in the previous 3 months
  • Patients with mental disease or disability
  • Had a stroke in the previous 6 months

结局指标

主要结局

Change in the medication adherence in intervention group vs. non-intervention group

时间窗: Baseline, at 3 months, and at 6 months

Visual Analogue Scale (VAS) for medication adherence: The participants will be asked to mark a line at the point along a continuum showing how much of each drug they have taken in the past month, this scare take range from 0 - 10. Unit of Measure is units on a Scale of 10

Change in the hyperlipidemia-Patient Knowledge in intervention group vs. non-intervention group

时间窗: Baseline, and At 6 months

Hyperlipidemia-Patient Knowledge Evaluation score: The Hyperlipidemia-Patient Knowledge Evaluation is a 17-item true-or-false questionnaire, which involved general knowledge, habit, diet, pharmacotherapy, and complications. The score ranges from 0 - 16. Unit of Measure is units on a Scale of 16

Change in the patient satisfaction

时间窗: Baseline, and At 6 months

Pharmaceutical Care Satisfaction Questionnaire (PCSQ) score for patient satisfaction: A 30-items score each item composed of a 5-point Likert scale (5 = strongly agree and 1 = strongly disagree), then the items are averaged and presented (value between 1 - 5) Unit of Measure is units on a Scale of 5

Change in the quality of life in intervention group vs. non-intervention group

时间窗: Baseline, and At 6 months

The RAND 36-items score (SF-36) for quality of life (QoL): This score composed of 36-items that contain 8 domains, the score has a range from 0 - 100 which represents the average of these domains. Unit of Measure is units on a Scale of 100

次要结局

  • Change in Serum LDL in intervention group vs. non-intervention group(Baseline, and At 6 months)
  • Change in Serum HDL in intervention group vs. non-intervention group(Baseline, and At 6 months)
  • Change in Serum cholesterol in intervention group vs. non-intervention group(Baseline, and At 6 months)
  • Rate of Medication-related problems manged(Up to 6 months)

研究者

发起方
Al-Rasheed University College
申办方类型
Other
责任方
Sponsor

研究点 (2)

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