NCT03024307

Brief 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. 1.rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
  2. 2.total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

October 11, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 18, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 4, 2021

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

October 11, 2016

Last Update Submit

March 3, 2021

Conditions

Rheumatic Diseases

Keywords

Pharmaceutical CareMedication AdherenceDirect Costs

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • Changes in medical outcomes from baseline at each visit by EQ5D-3L

    12 months

  • changes in direct costs from baseline at each visit

    12 months

Study Arms (2)

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

Other: pharmacists involved OPCSP

usual care only

NO INTERVENTION

Patients were provided with usual care.

Interventions

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.

Involvement of pharmacists in improving medication

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Patients who are unwilling to sign the inform consent;
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Campus, Ren Ji Hospital

Shanghai, 201112, China

Location

Related Publications (1)

  • 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.

    PMID: 31196083DERIVED

MeSH Terms

Conditions

Rheumatic DiseasesMedication Adherence

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Shuang Ye, MD

    RenJi Hospital

    STUDY CHAIR

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
Doctor

Study Record Dates

First Submitted

October 11, 2016

First Posted

January 18, 2017

Study Start

January 18, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 4, 2021

Record last verified: 2020-01

Locations

CN(1)