OsteoarthritisNCT05337709
Pharmacist Provided Intervention (Education and Medication Review) in Osteoarthritis
A study testing Education intervention and medication review in people with Osteoarthritis and Pain, run by Monash University Malaysia at 1 site in Nepal.
Trial summary
The purpose of this study is to initiate pharmacist intervention (educational and medication review) among osteoarthritis patients visiting community pharmacies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- Education intervention and medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jun 2022to 1 Dec 2022
- 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
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Shaun Lee Wen Huey contact
Nepal1 site, 1 recruiting
- Recruiting
Community Pharmacies
Pokhara, Gandaki
Srijana
About this study
Official title: Pharmacist Provided Intervention in Osteoarthritis: Community Pharmacies Based Trial
The purpose of this study is to initiate pharmacist intervention (educational and medication review) among osteoarthritis patients visiting community pharmacies.
Read the 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.
- Conditions
- Osteoarthritis, Pain
- Being tested
- Education intervention and medication review
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education intervention and medication reviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline, 3 months and 6 months
Secondary outcomes (3)
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.
Measured: baseline and 6 months
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.
Measured: baseline and 6 months
Patient satisfaction
Patient satisfaction will be assessed using the patient satisfaction questionnaire. Higher the score better is the satisfaction level.
Measured: At 6 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jun 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to either intervention or the control group
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parbati Thapa, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337709
- Sponsor's protocol ID
- 0
- Status last verified
- Aug 2022
- First submitted
- 7 Apr 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34997667Kielly 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.
PubMed 28507652Thapa 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.
PubMed 33486825Marra 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.
PubMed 22930542Hansson 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.
PubMed 20969809Thapa 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.
PubMed 37945419
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Provided Intervention in Osteoarthritis: Community Pharmacies Based Trial
- ClinicalTrials.gov ID
- NCT05337709
- Acronym / sponsor ID
- 0
- Conditions
- Osteoarthritis, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Monash University MalaysiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Apr 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to either intervention or the control group
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Other: Education intervention and medication reviewPatients from the pharmacies assigned as treatment group will receive intervention. Intervention are education (aid with leaflet and video) and medication review with counselling. |
| control group | No intervention | –Patients from the pharmacies assigned as control group will receive as usual care they have been provided regularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Education intervention and medication reviewEducation 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. | Other | treatment group |
Primary outcome
Change from baseline pain intensity at 3 and 6 months
Time frame: baseline, 3 months 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
Time frame: baseline, 3 months and 6 months (change in patients knowledge from baseline
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
Time frame: baseline, 3 months 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.
3 secondary outcomes
Change from baseline depression score at 6 months
Time frame: baseline and 6 months
Change from baseline patients quality of life at 6 months
Time frame: baseline and 6 months
Patient satisfaction
Time frame: At 6 months of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Background: PubMed 34997667McLachlan 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.
- Background: PubMed 28507652Kielly 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.
- Background: PubMed 33486825Thapa 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.
- Background: PubMed 22930542Marra 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.
- Background: PubMed 20969809Hansson 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.
- Derived from this study: PubMed 37945419Thapa 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.
- Individual participant dataSharing planned: Undecided
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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.
Shaun Lee Wen Huey contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education intervention and medication review in people with Osteoarthritis and Pain, run by Monash University Malaysia at 1 site in Nepal.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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 Nepal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Parbati Thapa (0165471475, parbati.thapa@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain intensity at 3 and 6 months (time frame: baseline, 3 months and 6 months). The study lists 3 primary outcomes in all. 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 NCT05337709, which also lists 6 linked publications.
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 26 Aug 2022.