NCT05410210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

May 13, 2022

Last Update Submit

October 9, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Pharmaceutical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 39945968DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yuvadee Pitakpatapee

    Yuvadee.pit@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants and assessors evaluating MDS-UPDRS were blinded in this study
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

June 8, 2022

Study Start

March 11, 2022

Primary Completion

December 2, 2022

Study Completion

January 23, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

TH(1)