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(Cost-)effectiveness of electronic drug monitoring feedback in order to decrease non-adherence in RA-patients starting with biological DMARD - A randomised clinical trial at Reade

(Cost-)effectiveness of electronic drug monitoring feedback in order to decrease non-adherence in RA-patients starting with biological DMARD - A randomised clinical trial at Reade - Electronic monitoring feedback of patient*s adherence in rheumatology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42203
Enrollment
227
Registered
2014-12-17
Start date
2016-02-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

Patients in the intervention group receive their medication during 1 year in an electronic device. Before each regular (3-monthly) consult to the rheumatologist, patients medication adherence will b

Sponsors

Jan van Breemen Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosed with RA (2010 ARA criteria or clinical judgment by a rheumatologist) Initiating a new (subcutaneously administered) bDMARD >18 years Sufficient ability to understand Dutch Be able to be followed for 12 months (life expectancy)

Exclusion criteria

Exclusion criteria: Large cognitive limitations Assistance in taking drugs (e.g. home care) Included in another randomised controlled trial

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the difference in proportion of non-adherence patients (less than 80% medication adherence) after 1 year between the intervention group and in the usual care control group assessed with the validated compliance questionnaire on rheumatology (CQR) and pharmacy refill data.

Secondary

MeasureTime frame
Secondary outcomes will be time to low disease activity and remission, serum trough levels (optional) and proportion of switching patients to another biological and mean disease activity after 1 year. Finally an economic evaluation of the possible added value of electronic drug monitor feedback compared with usual care will be done.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)