An interventional study of Pharmaceutical care in Parkinson Disease, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Mahidol University · Not applicable, Interventional, and Health services research
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 80 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Pharmaceutical 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.
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.
Change in the total number of drug-related problems related to all drugs
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.
Time frame: 24 weeks
Change in the number of drug-related problems related to with Parkinson's disease treatment
Compare the change of mean number of drug-related problems with Parkinson's disease treatment per person between the pharmaceutical care versus the usual care group.
Time frame: 24 weeks
Change in clinical outcome
Clinical outcome is assessed using Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores. Compare the change in MDS-UPDRS scores (both total score and separate part) between the pharmaceutical care group and the usual care group. The minimum and maximum value are 0 and 199, respectively. The higher scores mean a worse outcome.
Time frame: 12 and 24 weeks
Clinical status
Clinical status is assessed using Patient Global Impression of Change (PGIC). Compare the mean scores of PGIC at 12 and 24 weeks between the pharmaceutical care group and the usual care group. The minimum and maximum value are 1 and 7, respectively. The higher scores mean a worse outcome.
Time frame: 12 and 24 weeks
Change in Quality of life
Quality of life is assessed using the 8-item version of the Parkinson's Disease Questionnaire (PDQ-8). Compare the change in PDQ-8 scores between the pharmaceutical care group and the usual care group. The minimum and maximum value are 0 and 32, respectively. The higher scores mean a worse outcome.
Time frame: 24 weeks
The factors affecting the change in the number of drug-related problems
● The regression coefficient of the factors affecting the change in the number of drug-related problems were pharmaceutical care (yes/no), the number of drug-related problems at the start of the study (in items), the number of drug types the patient received at the start of the study (in items), disease duration (in years), and the Hoehn \& Yahr stage (2-4)
Time frame: 24 weeks
The factors affecting the change in the PGIC
● The regression coefficient of the factors affecting the change in the PGIC were pharmaceutical care (yes/no), the number of drug-related problems at the start of the study (in items), the number of drug types the patient received at the start of the study (in items), disease duration (in years), and the Hoehn \& Yahr stage (2-4)
Time frame: 24 weeks
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mahidol University