Back to resultsImpact of Pharmaceutical Care on Drug-related Problems in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Pharmaceutical care
Sponsored by
About this trial
This is an interventional health services research trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Siriraj hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pharmaceutical care
Usual care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05410210
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
January 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participants and assessors evaluating MDS-UPDRS were blinded in this study
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmaceutical care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pharmaceutical care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the total number of drug-related problems related to all drugs
Description
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
Secondary Outcome Measure Information:
Title
Change in the number of drug-related problems related to with Parkinson's disease treatment
Description
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
Title
Change in clinical outcome
Description
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
Title
Clinical status
Description
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
Title
Change in Quality of life
Description
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
Title
The factors affecting the change in the number of drug-related problems
Description
● 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
Title
The factors affecting the change in the PGIC
Description
● 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuvadee Pitakpatapee
Organizational Affiliation
Yuvadee.pit@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
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Impact of Pharmaceutical Care on Drug-related Problems in Patients With Parkinson's Disease
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