Clinical trial NCT05410210: Impact of Pharmaceutical Care on Drug-related Problems in Patients With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Diagnosed with idiopathic Parkinson's disease according to the UK Parkinson's disease Society Brain Bank Criteria for at least 3 years
3. Modified Hoehn and Yahr stage 2-4
4. Patient had received at least one of antiparkinsonian drugs the following: levodopa, MAO-B inhibitors, dopamine agonists, COMT inhibitors, amantadine, and trihexyphenidyl
5. 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:

1. Patient is unable to communicate via telephone or mobile phone or internet.
2. Patient who is terminal illness
3. Patient who is bed ridden
4. Patient with other movement disorders include corticobasal syndrome, multiple system atrophy, progressive supranuclear palsy and essential tremor
5. 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
6. 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
7. Patient with hearing impairments which affects communication via telephone or electronic media
8. Unable to communicate Thai language

Primary outcomes:
measure: Change in the total number of drug-related problems related to all drugs
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in the number of drug-related problems related to with Parkinson's disease treatment
timeFrame: 24 weeks
measure: Change in clinical outcome
timeFrame: 12 and 24 weeks
measure: Clinical status
timeFrame: 12 and 24 weeks
measure: Change in Quality of life
timeFrame: 24 weeks
measure: The factors affecting the change in the number of drug-related problems
timeFrame: 24 weeks
measure: The factors affecting the change in the PGIC
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Yuvadee.pit@gmail.com
name: Yuvadee Pitakpatapee
role: PRINCIPAL_INVESTIGATOR
References: