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Completed

NCT Number: NCT03024307

The Effect of OPCSP 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:

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Campus, Ren Ji Hospital

Shanghai, 201112, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

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

Treatment and study plan

pharmacists involved OPCSP

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 12 months

    The influence of OPCSP on improving medical outcomes would be evaluated by EQ5D-3L. The TTO value would be compared between two arms

  2. changes in direct costs from baseline at each visit

    Time frame: 12 months

    the influence of OPCSP on reducing direct costs

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Evaluation of an Outpatient Pharmacy Clinical Services Program on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2017
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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