Acceptability of a Nurse-led Telehealth Remote Self-monitoring Model of Care in Patients With Rheumatoid Arthritis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Quebec-Universite Laval

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to consent

Inability to complete questionnaires

No Internet access

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nurse-led telehealth remote self-monitoring

    Other intervention

    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.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Immediate intervention (for 16 months)Experimental treatment 1 intervention
Group B: Delayed intervention ( 8 months of control period followed by 8 months with the intervention)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability of the intervention evaluated by a questionnaire

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.

Time frame
At 16 months
2

Acceptability of the intervention evaluated by a qualitative analysis

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.

Time frame
At 16 months

Secondary outcomes

1

Age category of eligible participants

Age category of eligible patients

Time frame
Until the end of recruiting period
2

Frequency of calls to nurses

Frequency of calls to nurses will be collected on the electronic medical record of each rheumatology clinic

Time frame
Up to the end of intervention at 16 months
3

Use of other health care services

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.

Time frame
Every 3 months over 16 months
4

Health-related quality of life evaluated by the Patient-Reported Outcomes Measurement Information System-29 questionnaire

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.

Time frame
Every 3 months over 16 months

Other outcomes

Sponsors and contacts

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CHU de Quebec-Universite Laval

Lead sponsor

The Arthritis Society, Canada

Collaborator

This trial is not recruiting at the moment. You can still explore other options: