Parallel Randomized Study to Determine Pain Intensity and Quality of Life in Patients With Chronic Non-Cancer Pain Receiving Medication Review With Follow-up VS Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
The goal of this parallel-group, single-blinded, randomized study is to conduct Medication Review (MR) Type III in chronic non-cancer pain patients to optimize drug therapy and measure it's influence on Pain Intensity and Quality of Life in the primary care setting. The study took place in Porto, Portugal with the collaboration of two Primary Care Units (USF Arca D'Água and USF Campanhã - Polo S. Roque da Lameira) under ACeS Porto Oriental, from where patients were recruited. The main question it aims to answer is:
- Does the implementation of pharmacist-led medication review benefit patients with chronic pain in the primary care setting?
- Researchers will compare with "Usual Care" (UC) patients which receives general advice on how to manage their pain and/or recommendations to take "over the counter" drugs, similar to community pharmacy visits, to see if there is a clinically significant difference in pain intensity and quality of life between the two groups of patients.
- Participants will be asked to attend face-to-face interviews once a month for 4 months with an expert in medication review, that evaluates their current medication and suggests an individualized care plan. These plans include measures aimed at physicians (e.g., medication adding; dose reduction) and participants (e.g., non-pharmacological measures; adherence to medication).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This trial is blinded to subjects. Each subject will be informed they will be allocated to one of the two arms without knowing which one. Subjects will know they will receive pharmaceutical care, despite not knowing what type of pharmaceutical care they will receive.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-cancer chronic pain (>3 months, any cause)
- •Follow-up at one of the selected Primary Care Units
- •Average weekly pain score ≥4 at the screening phase
- •Ability to attend monthly in-person or video interviews
排除标准
- •Pregnancy
- •Breastfeeding
- •Other mental illness impairing self-reporting
研究组 & 干预措施
Medication Review (MR)
干预措施: Medication Review Type III (Other)
Usual-Care (UC)
干预措施: Usual Care (Other)
结局指标
主要结局
Pain Intensity
时间窗: From enrollment to the end of the interventions at 16 weeks
Following IMMPACT recommendations, subjects will record weekly pain (defined as the average of three measurements in a week) scores in the following manner: In a 11-point NRS with three descriptors where 0 is "no pain", 5 is "moderate pain" and 10 "maximum pain", subjects will select which best describes the pain they felt in the last 24h and record their score in the morning. Also, subjects will be instructed to record their pain scores on the week previous to the interventions.
次要结局
- Quality of Life (QoL)(From enrollment to the end of the interventions at 16 weeks)
- Satisfaction with treatment(From enrollment to the end of the interventions at 16 weeks)
研究者
Nuno Miguel da Silva Duarte
Principal Investigator
Polytechnic Institute of Porto