Rheumatoid Arthritis (RA)
Conditions
Keywords
Arthritis activity remote self-monitoring, Nurse-led telehealth intervention, Pilot randomised trial, Self-assessment of disease activity, RE-AIM implementation framework, Semi-structured interviews
Brief summary
Canada urgently needs new ways to provide rheumatology care that improve treatment and make it easier for people to get high-quality care. E-health technology is a new and promising way to do this, but it hasn't been studied much yet in rheumatology. The investigators will test a new way to help people with rheumatoid arthritis at four clinics in Quebec. This study will check if the new approach is easy to use, fits well into the clinics' daily routine, and if both patients and healthcare workers find it helpful and acceptable. This new approach involves nurses helping patients check their own health from home using an online platform. 104 adults who have rheumatoid arthritis and who have had a flare-up or a change in their medication in the last three months, will participate. Some will start using the online self-monitoring tool right away for 16 months, while others will continue with their usual care for 8 months before trying the tool. During the time they use the tool, they will fill out monthly online questionnaires to check their health. A rheumatology nurse will review their answers, suggest any needed care, provide personalized health information, and be available to answer questions through messages. This new way of care, where nurses help patients monitor their rheumatoid arthritis from home, helps make better use of limited specialist time. It's more convenient for patients, especially those who live far away, and helps meet their needs between regular doctor visits while keeping the quality of care high.
Detailed description
Background: Limited access to rheumatologists in Canadian remote regions leads to delays in new-onset rheumatoid arthritis (RA) diagnosis and inadequate follow-up for disease flares or treatment adjustments. There is a critical need for innovative models of care addressing these unmet needs in resource-limited settings. E-health technologies offer a promising solution by bridging the gap between in-person rheumatology appointments. These tools can optimize the use of scarce specialist resources, enhance the continuity and quality of care, and provide greater convenience for patients-particularly in underserved or geographically isolated areas. By supporting timely interventions and patient-centered monitoring, e-health can play a vital role in improving outcomes and ensuring equitable access to care. Objectives: This study will evaluate the acceptability and feasibility of a nurse-led telehealth remote self-monitoring model of care for patients with RA. Primary Objective: Acceptability of a nurse-led telehealth remote self-monitoring program, defined as patient-reported perceptions of usefulness, ease of use, attitudes, and overall experience, and assessed with questionnaires and semi-structured interviews. Secondary Objectives: Feasibility using the RE-AIM implementation framework: * Reach: Proportion of eligible patients enrolled and comparison of participant versus non-participant characteristics. * Effectiveness: Frequency and relevance of nurse calls, healthcare utilization, health-related quality of life, disease activity, and medication adherence. * Adoption: Completion rate of remote monitoring questionnaires, study retention, and reasons for discontinuation. * Implementation: Fidelity to protocol, appropriateness of alerts, subsequent actions, and timeliness of in-person visits; identify barriers and facilitators. * Maintenance: Intention for continued use among healthcare providers and patients. Methods - The investigators will recruit 104 adults with RA who experienced a flare or required a DMARDs switch within the preceding three months, from 4 rheumatology practices (community and academic sites) providing care to \>15,000 RA patients. All participants will be randomized 1:1 to receive either immediate intervention (for 16 months) or delayed, i.e. usual care for 8 months (control period) followed by 8 months of intervention, consisting of remote self-monitoring using a web platform co-developed with patients, rheumatologists, and nurses. Rheumatology visits will be scheduled every 3-6 months, with additional visits as necessary. The intervention includes nurse-led remote self-monitoring of RA, with patients completing monthly self-assessments of disease activity (RADAI), symptoms and function (PROMIS-29). Rheumatology nurses will receive alerts if monitoring suggests moderate/high disease activity and will contact participants to determine care needed. Tailored information based on PROMIS-29 answers will be sent to facilitate self-management. Asynchronous messaging with rheumatology nurses and information on RA self-management will be available. Data will be collected using questionnaires and semi-structured interviews. Analysis will use quantitative (generalized linear mixed-effect models comparing within group changes \[8 months - baseline, both groups combined\] and between groups differences \[intervention versus control\] in continuous variables), and qualitative methods (thematic content analysis by two independent researchers). Impact and feasibility. A nurse-led remote self-monitoring of RA using a web-based platform codeveloped with patient input, has potential to enhance access to care and more efficiently use scarce rheumatology resources while providing high quality care.
Interventions
OTHERNurse-led telehealth remote self-monitoring
Remote self-monitoring will use a web platform co-developed with patients, rheumatologists, and nurses. The intervention includes nurse-led remote self-monitoring of RA, with patients completing monthly self-assessments of disease activity (RADAI), symptoms and function (PROMIS-29). Rheumatology nurses will receive alerts if monitoring suggests moderate/high disease activity and will contact participants to determine care needed. Tailored information based on PROMIS-29 answers will be sent to facilitate self-management. Asynchronous messaging with rheumatology nurses and information on RA self-management will be available.
Sponsors
CHU de Quebec-Universite Laval
The Arthritis Society, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
One arm with immediate intervention for 16 months; and one arm with delayed intervention, i.e. usual care for 8 months (control period) followed by 8 months of intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of rheumatoid arthritis (RA) according to the ACR 2010 criteria * Disease duration ≥ six months * Who experienced a flare defined by an increase of the clinical disease activity index (CDAI) ≥ 4.5 or a DMARDs switch or addition within the preceding three months * Understanding French or English
Exclusion criteria
* Inability to consent * Inability to complete questionnaires * No Internet access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the intervention evaluated by a questionnaire | At 16 months | The questionnaire of patients' perceived usefulness and ease of use of the remote self-monitoring web platform will be completed by participants at 16 months, rated using a 13-item questionnaire utilizing five-point Likert scales. |
| Acceptability of the intervention evaluated by a qualitative analysis | At 16 months | Semi-structured interviews with patients and providers will be completed with a purposive sample of participants (diverse with respect to age, gender, ethnicity, education, disease type and duration, employment, urban/rural) at study end. Participants will meet in groups of 8-12 for 60-90 minutes; groups will continue until saturation of themes is obtained (estimated to be 2-3 groups). Topics will include perceived acceptability, convenience, satisfaction, beliefs, perceived usefulness and ease of use, how care received met patient needs, barriers and enablers to adopting this new model of care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age category of eligible participants | Until the end of recruiting period | Age category of eligible patients |
| Frequency of calls to nurses | Up to the end of intervention at 16 months | Frequency of calls to nurses will be collected on the electronic medical record of each rheumatology clinic |
| Use of other health care services | Every 3 months over 16 months | Self-reported by patients in a survey administered every three months, including emergency room visits, hospitalizations, visits to primary care physicians, other specialists, other healthcare professionals. |
| Health-related quality of life evaluated by the Patient-Reported Outcomes Measurement Information System-29 questionnaire | Every 3 months over 16 months | Measured by the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) which is a patient-reported measure of symptoms and function validated in French, which includes four items from each of seven domains (physical function, depression, anxiety, fatigue, sleep disturbances and ability to participate in social roles and activities, pain interference) and a single item on pain intensity. It has been co-developed with patients and validated in rheumatic diseases. Each item has five response options, except for pain which has eleven. A total score is calculated for each domain from the sum of item answers. Range from 20 to 80. |
| Disease activity evaluated by the Clinical Disease Activity Index | Every 3 to 6 months over 16 months | Measured using Clinical Disease Activity Index (CDAI) at every 3-6 months rheumatology follow-up visit The CDAI is the sum of the count of swollen/tender joint count of 28 joints and patient and physician global assessment on VAS (0-10 cm) Scale for estimating disease activity. The CDAI has range from 0 to 76. |
| Proportion of medication adherence | Every 3 months up to the end of intervention over 16 months | The proportion of adherence will be calculated by dividing the quantity received by the quantity prescribed for each month starting three months before enrollment until six months after. The mean proportion of adherence per medication will be calculated for each time period by taking the mean of all months included in each of the periods. For each of these periods, the patient will be considered adherent if the mean is greater or equal to 80%. |
| Completion rate of patient questionnaires for remote self-monitoring | Every month during the intervention over 16 months | Completion rate of patient questionnaires for remote self-monitoring (Rheumatoid Arthritis Disease Activity Index RADAI and Patient-Reported Outcomes Measurement Information System-29, PROMIS-29) |
| Proportion of participants still connecting to the web platform at study end | At 16 months | Proportion of participants still connecting to the web platform at study end |
| Time spent on the web platform | Up to the end of intervention at 16 months | Time spent on the web platform by each participant |
| Measuring the number of alerts per patient | Up to the end of intervention at 16 months | Measuring the number of alerts per patient |
| Questionnaire for the evaluation of health professionals' acceptance of a new telemonitoring system | At 16 months | Rheumatology nurses, rheumatologists, and administrative staff will answer the questionnaire for the evaluation of health professionals' acceptance of a new telemonitoring system, a 33-item anonymous survey on their intended sustained use of nurse-led remote self-monitoring with a 7-point likert scale for each questions. |
| Sex category of eligible patients | Up to the end of recruiting period | Sex category of eligible patients |
| Clinical appropriateness of alerts | Up to the end of intervention over 16 months | Clinical appropriateness of alerts based on rheumatology team subsequent actions (ex: timeliness of in-person visits, whether triggered visits led to medication change) |
| Number of nurse-patient interactions | Up to the end of intervention over 16 months | Number of nurse-patient interactions using the platform |
| Reason for nurse calls | Up to the end of intervention at 16 months | Reason for nurse calls will be collected on the electronic medical record of each rheumatology clinic |
Countries
Canada
Contacts
CONTACTLaetitia Michou, MD PhD
PRINCIPAL_INVESTIGATORLaetitia Michou, MD PhD
CHU de Quebec-Universite Laval
Outcome results
None listed