Rheumatic DiseasesNCT03024307
The Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
A study testing pharmacists involved OPCSP in people with Rheumatic Diseases, run by RenJi Hospital at 1 site in China.
Trial summary
This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The purpose of this study is to evaluate: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- pharmacists involved OPCSP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2017to 31 Dec 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness of the subject to participate in the study, proven by signing the informed consent;
- Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
- Patients fulfilled the American College of Rheumatology criteria for RA and AS;
Who cannot join
- Patients who are unwilling to sign the inform consent;
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Outpatient Pharmacy Clinical Services Program on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The purpose of this study is to evaluate:
- rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
- total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.
Read the detailed description
This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.Three types of rheumatic diseases were included in the study, Systemic lupus erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose of this study is to evaluate:
- rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
- total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.
- Conditions
- Rheumatic Diseases
- Being tested
- pharmacists involved OPCSP
- Keywords
- Pharmaceutical Care, Medication Adherence, Direct Costs
- Medical subject headings
- Rheumatic Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacists involved OPCSPOther
This was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.
| Study group | Role | What they receive |
|---|---|---|
| Involvement of pharmacists in improving medication | Experimental | Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up Receives: Other: pharmacists involved OPCSP |
| usual care only | No intervention | Patients were provided with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence in the OPCSP program compared with usual care
Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.
Measured: 12 months
Secondary outcomes (2)
Changes in medical outcomes from baseline at each visit by EQ5D-3L
The influence of OPCSP on improving medical outcomes would be evaluated by EQ5D-3L. The TTO value would be compared between two arms
Measured: 12 months
changes in direct costs from baseline at each visit
the influence of OPCSP on reducing direct costs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start18 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Li, RenJi Hospital
- Investigators
- Shuang Ye, MD, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024307
- Sponsor's protocol ID
- OPCSP2016
- Status last verified
- Jan 2020
- First submitted
- 11 Oct 2016
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang L, Luan W, Geng S, Ye S, Wang X, Qian L, Ding Y, Li T, Jiang A. Lack of patient education is risk factor of disease flare in patients with systemic lupus erythematosus in China. BMC Health Serv Res. 2019 Jun 13;19(1):378. doi: 10.1186/s12913-019-4206-y.
PubMed 31196083
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Outpatient Pharmacy Clinical Services Program on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT03024307
- Acronym / sponsor ID
- OPCSP2016
- Conditions
- Rheumatic Diseases
- Keywords
- Pharmaceutical Care, Medication Adherence, Direct Costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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.
This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The purpose of this study is to evaluate:
- rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
- total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.
Detailed description
This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.Three types of rheumatic diseases were included in the study, Systemic lupus erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose of this study is to evaluate:
- rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
- total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Involvement of pharmacists in improving medication | Experimental | Other: pharmacists involved OPCSPPharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up |
| usual care only | No intervention | –Patients were provided with usual care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness of the subject to participate in the study, proven by signing the informed consent;
- Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
- Patients fulfilled the American College of Rheumatology criteria for RA and AS;
Key exclusion criteria (2 listed)
- Patients who are unwilling to sign the inform consent;
- Pregnancy or lactation
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 |
|---|---|---|
| pharmacists involved OPCSPThis was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups. | Other | Involvement of pharmacists in improving medication |
Primary outcome
Medication adherence in the OPCSP program compared with usual care
Time frame: 12 months
Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.
2 secondary outcomes
Changes in medical outcomes from baseline at each visit by EQ5D-3L
Time frame: 12 months
changes in direct costs from baseline at each visit
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 31196083Zhang L, Luan W, Geng S, Ye S, Wang X, Qian L, Ding Y, Li T, Jiang A. Lack of patient education is risk factor of disease flare in patients with systemic lupus erythematosus in China. BMC Health Serv Res. 2019 Jun 13;19(1):378. doi: 10.1186/s12913-019-4206-y.
- 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.
Shuang Ye, MD study chair
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacists involved OPCSP in people with Rheumatic Diseases, run by RenJi Hospital at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 4 Mar 2021. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence in the OPCSP program compared with usual care (time frame: 12 months). 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 NCT03024307, which also lists 1 linked publication.
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 4 Mar 2021.