Pharmacist Provided Intervention (Education and Medication Review) in Osteoarthritis

NCT05337709 | Unknown DMC

• 1 other identifier: 0
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to initiate pharmacist intervention (educational and medication review) among osteoarthritis patients visiting community pharmacies.

Conditions

Osteoarthritis; Pain

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline, 3 months and 6 months

• 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.

  baseline, 3 months and 6 months (change in patients knowledge from baseline

• 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.

  baseline, 3 months and 6 months

Secondary Outcomes (3)

• Change from baseline depression score at 6 months

  baseline and 6 months

• Change from baseline patients quality of life at 6 months

  baseline and 6 months

• Patient satisfaction

  At 6 months of enrollment

Study Arms (2)

treatment group

EXPERIMENTAL

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

Other: Education intervention and medication review

control group

NO INTERVENTION

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

Interventions

Education intervention and medication review OTHER

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.

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Monash University Malaysia: lead

Study Sites (1)

Community Pharmacies

Pokhara, Gandaki, Nepal

RECRUITING

Related Publications (6)

• 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.

  PMID: 34997667 BACKGROUND

• 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.

  PMID: 28507652 BACKGROUND

• 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.

  PMID: 33486825 BACKGROUND

• 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.

  PMID: 22930542 BACKGROUND

• 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.

  PMID: 20969809 BACKGROUND

• Thapa P, Kc B, Gyawali S, Leong SL, Mohamed Ibrahim MI, Lee SWH. Effectiveness of community pharmacist-led interventions in osteoarthritis pain management: A cluster-randomized trial. Res Social Adm Pharm. 2024 Feb;20(2):149-156. doi: 10.1016/j.sapharm.2023.10.012. Epub 2023 Nov 4.

  PMID: 37945419 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Central Study Contacts

Parbati Thapa

CONTACT

0165471475; parbati.thapa@monash.edu

Shaun Lee Wen Huey

CONTACT

shaun.lee@monash.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Principal Investigator

Model Details: Patients will be assigned to either intervention or the control group

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 20, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

NE (1)