Parkinson DiseaseNCT05410210
Impact of Pharmaceutical Care on Drug-related Problems in Patients With Parkinson's Disease
A study testing Pharmaceutical care in people with Parkinson Disease, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 11 Mar 2022to 23 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Pharmaceutical care
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical care | Experimental | 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. Receives: Other: Pharmaceutical care |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start11 Mar 2022
- Primary completion2 Dec 2022
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuvadee Pitakpatapee, Principal investigator, Yuvadee.pit@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410210
- Sponsor's protocol ID
- 1040/2564(IRB4) MOU
- Status last verified
- Oct 2023
- First submitted
- 13 May 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Techa-Angkoon P, Pitakpatapee Y, Saengphatrachai W, Srivanitchapoom P, Suansanae T. Impact of pharmacist-physician collaboration on patient outcomes in Parkinson's disease: a randomised controlled trial in tertiary care. Int J Clin Pharm. 2025 Jun;47(3):834-843. doi: 10.1007/s11096-025-01883-6. Epub 2025 Feb 13.
PubMed 39945968
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05410210
- Acronym / sponsor ID
- 1040/2564(IRB4) MOU
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical care | Experimental | Other: Pharmaceutical careThe 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical careThe 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. | Other | Pharmaceutical care |
Primary outcome
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.
6 secondary outcomes
Change in the number of drug-related problems related to with Parkinson's disease treatment
Time frame: 24 weeks
Change in clinical outcome
Time frame: 12 and 24 weeks
Clinical status
Time frame: 12 and 24 weeks
Change in Quality of life
Time frame: 24 weeks
The factors affecting the change in the number of drug-related problems
Time frame: 24 weeks
The factors affecting the change in the PGIC
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 39945968Techa-Angkoon P, Pitakpatapee Y, Saengphatrachai W, Srivanitchapoom P, Suansanae T. Impact of pharmacist-physician collaboration on patient outcomes in Parkinson's disease: a randomised controlled trial in tertiary care. Int J Clin Pharm. 2025 Jun;47(3):834-843. doi: 10.1007/s11096-025-01883-6. Epub 2025 Feb 13.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuvadee Pitakpatapee principal investigator
Yuvadee.pit@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care in people with Parkinson Disease, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the total number of drug-related problems related to all drugs (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.