A Randomized Controlled Trial to Study the Impact of Pharmaceutical Care on Drug-related Problems in Patients With Parkinson's Disease at Parkinson's Disease and Movement Disorders Clinic, Siriraj Hospital, Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in the total number of drug-related problems related to all drugs
研究概览
简要总结
The aim of this study is to evaluate the impact of pharmaceutical care on the number of drug-related problems, clinical outcomes and quality of life of patients with Parkinson's disease.
详细描述
This is a randomized controlled study that will be conducted in Parkinson's disease and movement disorders clinic, Siriraj Hospital, Thailand. The participants and assessors evaluating MDS-UPDRS were blinded in this study.
The participants will be divided into two groups by block randomization: intervention group and usual care group.
For the intervention group, the clinical pharmacists will conduct medication reviews, patient education, and counseling. Moreover, the clinical pharmacists will identify drug-related problems (DRPs) and provide the information through written pharmacist notes to physicians at the clinic. For patients randomized to the control group will attend the medical follow-up as usual and receive usual care. Telepharmacy will be conducted 2-7 days before the doctor visit and within 1 week after the doctor visit. Data collection will be conducted at baseline, week 12, and week 24 in both groups. After the follow-up, the pharmacist will count the number of drug-related problems identified after the doctor visit. The primary outcome of the study is comparing the number of drug-related problems per person changed from the start of the study to the end of week 24 between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
The participants and assessors evaluating MDS-UPDRS were blinded in this study
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
- •Age 18 years or older
- •Diagnosed with idiopathic Parkinson's disease according to the UK Parkinson's disease Society Brain Bank Criteria for at least 3 years
- •Modified Hoehn and Yahr stage 2-4
- •Patient had received at least one of antiparkinsonian drugs the following: levodopa, MAO-B inhibitors, dopamine agonists, COMT inhibitors, amantadine, and trihexyphenidyl
- •Patient has given a written informed consent to participate in the study. If the patients are unable to give an informed consent, it must be obtained from the caregiver.
排除标准
- •Patient is unable to communicate via telephone or mobile phone or internet.
- •Patient who is terminal illness
- •Patient who is bed ridden
- •Patient with other movement disorders include corticobasal syndrome, multiple system atrophy, progressive supranuclear palsy and essential tremor
- •Moderate to severe dementia as evidenced by Mini Mental State Examination (MMSE) or Thai Mental State Examination (TMSE) less than 20 and without the caregiver
- •Patient who is planning to undergo surgery or have a history of surgical treatment for Parkinson's disease such as pallidotomy, thalamotomy, or deep brain stimulation
- •Patient with hearing impairments which affects communication via telephone or electronic media
- •Unable to communicate Thai language
研究组 & 干预措施
Pharmaceutical care
The intervention group will receive the pharmaceutical care from a pharmacist and the existing standard care available in the Parkinson's disease and movement disorders clinic.
干预措施: Pharmaceutical care (Other)
Usual care
The usual care includes the current existing care provided to patients in the Parkinson's disease and movement disorders clinic except the pharmaceutical care provided by pharmacists.
结局指标
主要结局
Change in the total number of drug-related problems related to all drugs
时间窗: 24 weeks
Compare the change of mean number of drug-related problems related to all drugs per person between the pharmaceutical care versus the usual care group.
次要结局
- Change in the number of drug-related problems related to with Parkinson's disease treatment(24 weeks)
- Change in clinical outcome(12 and 24 weeks)
- Clinical status(12 and 24 weeks)
- Change in Quality of life(24 weeks)
- The factors affecting the change in the number of drug-related problems(24 weeks)
- The factors affecting the change in the PGIC(24 weeks)