Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05425485 |
| Other study ID # |
4710 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
October 31, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Based on recent guidelines, the investigators have developed a parallel (patient and
physician) educational web-based tool. To prove its effectiveness, the investigators have
designed a cluster clinical trial of a 6-month duration in which 15 centres will be
randomised to receive access and instruction on the strategy or to continue standard care.
The trial endpoint is adherence at the patient level, for which each centre will recruit 15
consecutive patients and measure adherence (medication, physical activity, Mediterranean
diet) and disease activity as of baseline and 6 months after.
Description:
Treatment adherence in patients with rheumatoid arthritis (RA) is estimated to be between
50-80%. Non-adherence is a health problem with a significant economic impact. The causes of
non-adherence are multiple and require individualized care that is difficult both to
implement at the professional level and to prove effective.
Based on recent international recommendations and previous work from the research team, plus
a qualitative study with multi-stakeholders, the investigators have designed a web-based
strategy to avoid non-adherence in RA.
The primary objective is to evaluate the effectiveness of an evidence-based, consensus-based
adherence intervention strategy for improving adherence in patients with RA.
Secondary objectives are to evaluate the impact on disease activity, healthy habits
(diet/exercise), cardiovascular risk factors, quality of life and patient satisfaction.
The investigators have designed a cluster clinical trial of 6-month duration.
Fifteen centres will be randomised to receive access and instruction on the strategy or to
continue standard care. Centre recruitment is on a voluntary basis, understanding that access
to the educational tool will be delayed in case of being assigned to the control group.
The intervention is a web-based tool with educational and practical materials for the patient
and for the physician (this part will be protected with a password during the duration of the
trial). Physicians (prescribers or non-prescribers) in centres assigned to the intervention
will be invited to be instructed on the materials (text, videos, checklists, calendars, etc).
Control will be standard care.
Each centre will recruit 15 consecutive adult patients with rheumatoid arthritis (as stated
in the clinical records), less than 2 years since diagnosis and living independently.
The primary outcome will be therapeutic adherence (patient-level), defined as a score ≥ 80%
in the Compliance Questionnaire on Rheumatology (CQR) and in the Adherence Medication Scale
(RAM).
Secondary outcomes will be adherence to physical activity, a Mediterranean diet, lifestyle
changes and disease activity.
Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 79 patients
per group are required, assuming that the initial proportion of adherent patients is 70% and
at the end of the intervention, it would increase to 90% (only in the intervention group, in
the control it would not change). A lost-to-follow-up rate of 25% has been estimated.
If 10 centres are selected to have at least 5 clusters for each group, this would correspond,
rounding up, to 16 patients per centre, or a total of 160 patients.
The effect of the intervention on adherence to treatment will be refuted by the chi-square
test and measured by relative risk (RR) and difference of proportions.
