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NCT07525856

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

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 7 months later.

See at-risk trials from CHU de Quebec-Universite Laval

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 2027 to May 2028 Show 6 more changesShow less
    • Start date: May 2026 to Jan 2027
    • Study completion pushed from Dec 2027 to Jun 2028
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 15 entries
    • Site details revised at 1 of 4 sites
    • Study description expanded, about 5 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Acceptability of the intervention evaluated by a questionnaire
Timeframe: At 16 months
Acceptability of the intervention evaluated by a qualitative analysis
Timeframe: At 16 months

Secondary (15)

Age category of eligible participants
Frequency of calls to nurses
Use of other health care services
Health-related quality of life evaluated by the Patient-Reported Outcomes Measurement Information System-29 questionnaire
Disease activity evaluated by the Clinical Disease Activity Index
Show 10 moreShow less
Proportion of medication adherence
Completion rate of patient questionnaires for remote self-monitoring
Proportion of participants still connecting to the web platform at study end
Time spent on the web platform
Measuring the number of alerts per patient
Questionnaire for the evaluation of health professionals' acceptance of a new telemonitoring system
Sex category of eligible patients
Clinical appropriateness of alerts
Number of nurse-patient interactions
Reason for nurse calls

Arms and interventions

Immediate intervention (for 16 months)Experimental

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.

Delayed intervention ( 8 months of control period followed by 8 months with the intervention)Active comparator

Usual care for 8 months, consisting in rheumatology visits scheduled every 3-6 months. Followed by the intervention for 8 months: 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.

Other: Nurse-led telehealth remote self-monitoring

Sites

4 sites in 1 country