Pharmacist Provided Intervention in Osteoarthritis: Community Pharmacies Based Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Change from baseline pain intensity at 3 and 6 months
研究概览
简要总结
The purpose of this study is to initiate pharmacist intervention (educational and medication review) among osteoarthritis patients visiting community pharmacies.
详细描述
Community pharmacists are one of the most accessible health care professionals for patient care in chronic diseases including osteoarthritis and can provide patient education, conduct medication review, and collaborate with the multidisciplinary pain management team, to improve treatment outcomes and quality of life. Studies have reported that pharmacist-provided intervention was beneficial as it increased patients' knowledge of osteoarthritis, reduced the rates of adverse events associated with analgesics, and improved self-perceived health and function. So this study aims to provide intervention through community pharmacists.
Potential patients will be identified from community pharmacies and consent will be obtained from patients before enrolling them in the study. The study will be a cluster-randomized trial. Thus pharmacies will be randomized, either to control or treatment group. Patients in the treatment group will receive the pharmacist-initiated intervention while in the control group will receive usual care.
The intervention will be an education on osteoarthritis, its management, and self-care activities followed by a medication review. Pharmacists assess patients' knowledge of medication indication, identify adverse effects or drug-related problems, and counsel patients on proper medication use.
Education intervention will be provided through face-to-face communication at the time of enrollment and a leaflet will be provided. The patient will receive a phone call and will be able to view the video in the succeeding weeks to enforce the intervention.
Outcome measures will be assessed at baseline, three months, and six months from enrolment in both treatment and control groups.
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
- •Patient aged 18 years and above with the complaint of osteoarthritis
- •Patient willing to participate in the study
- •Patient with chronic pain (persisting for more than three months)
排除标准
- •Patient unable to provide the consent due to severe mental health, cognitive impairment or learning difficulties
- •Patient with a terminal illness
- •Patient having sufficient knowledge on osteoarthritis, its management and self-care activities as assessed from the questionnaire (respond correctly to 80% of the question or above)
结局指标
主要结局
Change from baseline pain intensity at 3 and 6 months
时间窗: baseline, 3 months and 6 months
Numeric pain rating scale will be used to measure the pain intensity. The numeric pain rating scale (NPRS) is an 11-point scale. Respondents can choose a number between 0 to 10, where 0 = no pain and 10 = extreme or worst pain. It has shown a high correlation with the visual analogue scale and can be used in rheumatoid arthritis and other types of chronic pain. It can be administered verbally to be done over the telephone. It has been translated into the Nepalese language.
Change from baseline patient's knowledge at 3 and 6 months
时间窗: baseline, 3 months and 6 months (change in patients knowledge from baseline
Patient knowledge will be assessed using the questionnaire developed by the principal investigator in consultation with literature review and expert consultation. It consists of 12 questions on osteoarthritis and pain management. It has been translated into Nepalese languages and validated. Correct responses will be counted and presented as percentages. Higher percentages mean better knowledge.
Change from baseline physical function at 3 and 6 months
时间窗: baseline, 3 months and 6 months
Western Ontario and Mc Master Universities Arthritis Index (WOMAC) is the tool commonly used for evaluation in osteoarthritis.It consist of 24 items divided into 3 subscales; pain (5 items), stiffness (2 items), physical Function (17 items). Its response is based on a number between 0 to 4, where 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme.
次要结局
- Change from baseline patients quality of life at 6 months(baseline and 6 months)
- Change from baseline depression score at 6 months(baseline and 6 months)
- Patient satisfaction(At 6 months of enrollment)
研究者
Parbati Thapa
PhD Student, Principal Investigator
Monash University Malaysia