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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Change in the total number of drug-related problems related to all drugs
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
The participants and assessors evaluating MDS-UPDRS were blinded in this study
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in the total number of drug-related problems related to all drugs
Time Frame: 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.
Secondary Outcomes
- 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)