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Pharmacist Provided Intervention (Education and Medication Review) in Osteoarthritis

Primary Purpose

Osteoarthritis, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Education intervention and medication review
Sponsored by
Monash University Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient aged 18 years and above with the complaint of osteoarthritis
  • Patient willing to participate in the study
  • Patient with chronic pain (persisting for more than three months)

Exclusion Criteria:

  • Patient unable to provide the consent due to severe mental health, cognitive impairment or learning difficulties
  • Patient with a terminal illness
  • Patient having sufficient knowledge on osteoarthritis, its management and self-care activities as assessed from the questionnaire (respond correctly to 80% of the question or above)

Sites / Locations

  • Community PharmaciesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment group

control group

Arm Description

Patients from the pharmacies assigned as treatment group will receive intervention. Intervention are education (aid with leaflet and video) and medication review with counselling.

Patients from the pharmacies assigned as control group will receive as usual care they have been provided regularly.

Outcomes

Primary Outcome Measures

Change from baseline pain intensity at 3 and 6 months
Numeric pain rating scale will be used to measure the pain intensity. The numeric pain rating scale (NPRS) is an 11-point scale. Respondents can choose a number between 0 to 10, where 0 = no pain and 10 = extreme or worst pain. It has shown a high correlation with the visual analogue scale and can be used in rheumatoid arthritis and other types of chronic pain. It can be administered verbally to be done over the telephone. It has been translated into the Nepalese language.
Change from baseline patient's knowledge at 3 and 6 months
Patient knowledge will be assessed using the questionnaire developed by the principal investigator in consultation with literature review and expert consultation. It consists of 12 questions on osteoarthritis and pain management. It has been translated into Nepalese languages and validated. Correct responses will be counted and presented as percentages. Higher percentages mean better knowledge.
Change from baseline physical function at 3 and 6 months
Western Ontario and Mc Master Universities Arthritis Index (WOMAC) is the tool commonly used for evaluation in osteoarthritis.It consist of 24 items divided into 3 subscales; pain (5 items), stiffness (2 items), physical Function (17 items). Its response is based on a number between 0 to 4, where 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme.

Secondary Outcome Measures

Change from baseline depression score at 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale 8 items: is a set of person-centred measures that evaluates mental health in adults and children. It can be used with the general population and individuals living with chronic conditions. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Change from baseline patients quality of life at 6 months
The quality of life assessment questionnaire EQ-5D-3L (EUROQOL) is one of the most common tools to measure health-related quality of life. It helps to assess the Quality of life-based on five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Patient satisfaction
Patient satisfaction will be assessed using the patient satisfaction questionnaire. Higher the score better is the satisfaction level.

Full Information

First Posted
April 7, 2022
Last Updated
August 23, 2022
Sponsor
Monash University Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05337709
Brief Title
Pharmacist Provided Intervention (Education and Medication Review) in Osteoarthritis
Official Title
Pharmacist Provided Intervention in Osteoarthritis: Community Pharmacies Based Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to initiate pharmacist intervention (educational and medication review) among osteoarthritis patients visiting community pharmacies.
Detailed Description
Community pharmacists are one of the most accessible health care professionals for patient care in chronic diseases including osteoarthritis and can provide patient education, conduct medication review, and collaborate with the multidisciplinary pain management team, to improve treatment outcomes and quality of life. Studies have reported that pharmacist-provided intervention was beneficial as it increased patients' knowledge of osteoarthritis, reduced the rates of adverse events associated with analgesics, and improved self-perceived health and function. So this study aims to provide intervention through community pharmacists. Potential patients will be identified from community pharmacies and consent will be obtained from patients before enrolling them in the study. The study will be a cluster-randomized trial. Thus pharmacies will be randomized, either to control or treatment group. Patients in the treatment group will receive the pharmacist-initiated intervention while in the control group will receive usual care. The intervention will be an education on osteoarthritis, its management, and self-care activities followed by a medication review. Pharmacists assess patients' knowledge of medication indication, identify adverse effects or drug-related problems, and counsel patients on proper medication use. Education intervention will be provided through face-to-face communication at the time of enrollment and a leaflet will be provided. The patient will receive a phone call and will be able to view the video in the succeeding weeks to enforce the intervention. Outcome measures will be assessed at baseline, three months, and six months from enrolment in both treatment and control groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to either intervention or the control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
Patients from the pharmacies assigned as treatment group will receive intervention. Intervention are education (aid with leaflet and video) and medication review with counselling.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients from the pharmacies assigned as control group will receive as usual care they have been provided regularly.
Intervention Type
Other
Intervention Name(s)
Education intervention and medication review
Intervention Description
Education on osteoarthritis and pain management will be provided to the patients by face-to-face communication at the first meeting, aided with a leaflet, then patients will get the follow-up calls and a video will be shown to enforce the intervention. Medication review includes the assessment of patients' knowledge on the indication, identification of any drug-related problem, and counseling on the proper use of medication.
Primary Outcome Measure Information:
Title
Change from baseline pain intensity at 3 and 6 months
Description
Numeric pain rating scale will be used to measure the pain intensity. The numeric pain rating scale (NPRS) is an 11-point scale. Respondents can choose a number between 0 to 10, where 0 = no pain and 10 = extreme or worst pain. It has shown a high correlation with the visual analogue scale and can be used in rheumatoid arthritis and other types of chronic pain. It can be administered verbally to be done over the telephone. It has been translated into the Nepalese language.
Time Frame
baseline, 3 months and 6 months
Title
Change from baseline patient's knowledge at 3 and 6 months
Description
Patient knowledge will be assessed using the questionnaire developed by the principal investigator in consultation with literature review and expert consultation. It consists of 12 questions on osteoarthritis and pain management. It has been translated into Nepalese languages and validated. Correct responses will be counted and presented as percentages. Higher percentages mean better knowledge.
Time Frame
baseline, 3 months and 6 months (change in patients knowledge from baseline
Title
Change from baseline physical function at 3 and 6 months
Description
Western Ontario and Mc Master Universities Arthritis Index (WOMAC) is the tool commonly used for evaluation in osteoarthritis.It consist of 24 items divided into 3 subscales; pain (5 items), stiffness (2 items), physical Function (17 items). Its response is based on a number between 0 to 4, where 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme.
Time Frame
baseline, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Change from baseline depression score at 6 months
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale 8 items: is a set of person-centred measures that evaluates mental health in adults and children. It can be used with the general population and individuals living with chronic conditions. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Time Frame
baseline and 6 months
Title
Change from baseline patients quality of life at 6 months
Description
The quality of life assessment questionnaire EQ-5D-3L (EUROQOL) is one of the most common tools to measure health-related quality of life. It helps to assess the Quality of life-based on five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Time Frame
baseline and 6 months
Title
Patient satisfaction
Description
Patient satisfaction will be assessed using the patient satisfaction questionnaire. Higher the score better is the satisfaction level.
Time Frame
At 6 months of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged 18 years and above with the complaint of osteoarthritis Patient willing to participate in the study Patient with chronic pain (persisting for more than three months) Exclusion Criteria: Patient unable to provide the consent due to severe mental health, cognitive impairment or learning difficulties Patient with a terminal illness Patient having sufficient knowledge on osteoarthritis, its management and self-care activities as assessed from the questionnaire (respond correctly to 80% of the question or above)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parbati Thapa
Phone
0165471475
Email
parbati.thapa@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shaun Lee Wen Huey
Email
shaun.lee@monash.edu
Facility Information:
Facility Name
Community Pharmacies
City
Pokhara
State/Province
Gandaki
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srijana

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34997667
Citation
McLachlan AJ, Carroll PR, Hunter DJ, Wakefield TAN, Stosic R. Osteoarthritis management: Does the pharmacist play a role in bridging the gap between what patients actually know and what they ought to know? Insights from a national online survey. Health Expect. 2022 Jun;25(3):936-946. doi: 10.1111/hex.13429. Epub 2022 Jan 8.
Results Reference
background
PubMed Identifier
28507652
Citation
Kielly J, Davis EM, Marra C. Practice guidelines for pharmacists: The management of osteoarthritis. Can Pharm J (Ott). 2017 May 1;150(3):156-168. doi: 10.1177/1715163517702168. eCollection 2017 May-Jun. No abstract available.
Results Reference
background
PubMed Identifier
33486825
Citation
Thapa P, Lee SWH, Kc B, Dujaili JA, Mohamed Ibrahim MI, Gyawali S. Pharmacist-led intervention on chronic pain management: A systematic review and meta-analysis. Br J Clin Pharmacol. 2021 Aug;87(8):3028-3042. doi: 10.1111/bcp.14745. Epub 2021 Feb 24.
Results Reference
background
PubMed Identifier
22930542
Citation
Marra CA, Cibere J, Grubisic M, Grindrod KA, Gastonguay L, Thomas JM, Embley P, Colley L, Tsuyuki RT, Khan KM, Esdaile JM. Pharmacist-initiated intervention trial in osteoarthritis: a multidisciplinary intervention for knee osteoarthritis. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1837-45. doi: 10.1002/acr.21763.
Results Reference
background
PubMed Identifier
20969809
Citation
Hansson EE, Jonsson-Lundgren M, Ronnheden AM, Sorensson E, Bjarnung A, Dahlberg LE. Effect of an education programme for patients with osteoarthritis in primary care--a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:244. doi: 10.1186/1471-2474-11-244.
Results Reference
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Pharmacist Provided Intervention (Education and Medication Review) in Osteoarthritis

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