The SeMoRA-3 study. Self-monitoring in rheumatoid arthritis: the implementation of a digital care platform using smartphone technology for monitoring of disease activity.

The SeMoRA-3 study. Self-monitoring in rheumatoid arthritis: the implementation of a digital care platform using smartphone technology for monitoring of disease activity. - SeMoRA-3

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49364

Enrollment

103

Registered

2019-04-11

Start date

2019-05-23

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

rheumatoid arthritis

Interventions

The digital care platform as described in the objective.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: To be included in this study, participants must: * be diagnosed with rheumatoid arthritis by a rheumatologist * have a disease duration of at least 2 years * be in low disease activity or remission (DAS28

Exclusion criteria

Exclusion criteria: * taking part in another intervention study * Medication change: start or stop of a DMARD(biologicals, or conventional DMARDS*) in the last 6 months. , *Methotrexate, cyclosporine, cyclophosphamide, gold injections, hydroxychloroquine, leflunomide, mycophenolate, sulfasalazine, corticosteroids.

Design outcomes

Primary

Measure	Time frame
* health care utilization as measured by the mean number of outpatient clinic visits with a rheumatologist during the 12 months trial period. * disease activity as measured by the mean DAS28 at 12 months	—

Secondary

Measure	Time frame
* Health care satisfaction on a 10 point scale as recommended by the Institute for Healthcare Improvement. 38 Using any number from 0 to 10, where 0 is the worst health care possible and 10 is as the best health care possible, what number would you use to rate all your health care in the last 12 months?* * Patient empowerment as measured by the Effective Consumer scale (EC-17) * Disease activity as measured by Routine Assessment of Patient Index Data (RAPID3) * Patient-physician interaction as measured by the Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) * Treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (the TSQM questionnaire) * Medication adherence as measured by the CQR5 Compliance Questionnaire Rheumatology (CQR5) * Participation as measured by Work Productivity and Activity Impairment Questionnaire (WPAI) * Overall costs of health care utilization including medication use and number of telephone appointments with a rheumatology health care professional as measured by a detailed questionnaire and retrieved from the Reade EMR * Treating physician satisfaction as measured by a physician visit and exit form * Qualitative data derived from focus group discussions at the end of the trial period * Exploratory analysis on the causes of flares * completion rates of weekly surveys as proxies for patient engagement and overall feasibility. * system usability score (SUS)	—

Measure

Time frame

* Health care satisfaction on a 10 point scale as recommended by the Institute for Healthcare Improvement. 38 Using any number from 0 to 10, where 0 is the worst health care possible and 10 is as the best health care possible, what number would you use to rate all your health care in the last 12 months?* * Patient empowerment as measured by the Effective Consumer scale (EC-17) * Disease activity as measured by Routine Assessment of Patient Index Data (RAPID3) * Patient-physician interaction as measured by the Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) * Treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (the TSQM questionnaire) * Medication adherence as measured by the CQR5 Compliance Questionnaire Rheumatology (CQR5) * Participation as measured by Work Productivity and Activity Impairment Questionnaire (WPAI) * Overall costs of health care utilization including medication use and number of telephone appointments with a rheumatology health care professional as measured by a detailed questionnaire and retrieved from the Reade EMR * Treating physician satisfaction as measured by a physician visit and exit form * Qualitative data derived from focus group discussions at the end of the trial period * Exploratory analysis on the causes of flares * completion rates of weekly surveys as proxies for patient engagement and overall feasibility. * system usability score (SUS)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)