Rheum@Home: RA Remote Patient Monitoring (R@H)
Primary Purpose
Rheumatoid Arthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
care via the telemedicine system
Routine care
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: all consecutive patients; signed, written informed consent; 18 -75 years of age; clinical diagnosis of RA; ≥ 6 months stable low disease activity or remission, according to the treating rheumatologist; able to read and understand simple Dutch language instructions; ownership or access to a smartphone, tablet or computer and having internet access; able to conduct a teleconsultation on a smartphone, tablet or computer. Exclusion Criteria: severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist
Sites / Locations
- Medisch Spectrum Twente
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Care via the telemedicine system
Standard care
Arm Description
Intervention
Control
Outcomes
Primary Outcome Measures
Number of rheumatology outpatient visits with rheumatologists and nurses
Number of rheumatology outpatient visits with rheumatologists and nurses
Patient-reported quality of care
measured with visual analogue scale (VAS) scores (0-10; higher score indicates higher quality) in seven relevant domains: patients' satisfaction with health care, patients' experiences contacting their health-care providers, the extent to which health care meets patients' expectations, healthcare workers' timeliness of response to questions and symptoms, health-care workers' fulfilment of agreements, health-care workers attentiveness to acute situations, and hospital accessibility in case of symptoms. A mean score of 8 out of 10 or higher was predefined as perceived high quality
Secondary Outcome Measures
Number of rheumatology teleconsultations (email, telephone, video)
Number of rheumatology teleconsultations (email, telephone, video)
DAS28
Disease Activity Score
PROMs: disease activity score (RAPID3)
PROMs: disease activity score (RAPID3)
PROMs: Patient acceptable symptom state (PASS)
PROMs: Patient acceptable symptom state (PASS)
PROMs: participation (WPAI)
PROMs: participation (WPAI)
PROMs: pain (NRS)
PROMs: pain (NRS)
PROMs: fatigue (NRS)
PROMs: fatigue (NRS)
PROMs: physical function (HAQ-DI)
PROMs: physical function (HAQ-DI)
PROMs: health related quality of life (EQ5D)
PROMs: health related quality of life (EQ5D)
PROMs: health related quality of life (SF36)
PROMs: health related quality of life (SF36)
Physical performance: 50 meter walking test
Physical performance: 50 meter walking test
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
(S)AE's assessed by CTCAE v4.0
Cost-effectiveness: healthcare utilization questionnaire
Cost-effectiveness: healthcare utilization questionnaire
Patient experience: System usability scale (SUS)
Patient experience: System usability scale (SUS)
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Full Information
NCT ID
NCT05725577
First Posted
December 13, 2022
Last Updated
April 19, 2023
Sponsor
Medisch Spectrum Twente
Collaborators
University of Twente, Reade Rheumatology Research Institute, Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05725577
Brief Title
Rheum@Home: RA Remote Patient Monitoring
Acronym
R@H
Official Title
Rheum@Home: Rheumatoid Arthritis Care in the 21th Century
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medisch Spectrum Twente
Collaborators
University of Twente, Reade Rheumatology Research Institute, Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with Rheum@Home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis.
Participants will be asked to
complete questionaires every 4 weeks
perform a walking test every 4 weeks
routine lab
routine disease activity measurement by a qualified assessor
Researchers will compare care via the telemedicine system (intervention) or standard care (control) to see if there are differences in the number of rheumatology outpatient visits and patient reported quality of care after 12 months follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Care via the telemedicine system
Arm Type
Other
Arm Description
Intervention
Arm Title
Standard care
Arm Type
Other
Arm Description
Control
Intervention Type
Other
Intervention Name(s)
care via the telemedicine system
Intervention Description
Care via the telemedicine system
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Routine care
Primary Outcome Measure Information:
Title
Number of rheumatology outpatient visits with rheumatologists and nurses
Description
Number of rheumatology outpatient visits with rheumatologists and nurses
Time Frame
12 month period
Title
Patient-reported quality of care
Description
measured with visual analogue scale (VAS) scores (0-10; higher score indicates higher quality) in seven relevant domains: patients' satisfaction with health care, patients' experiences contacting their health-care providers, the extent to which health care meets patients' expectations, healthcare workers' timeliness of response to questions and symptoms, health-care workers' fulfilment of agreements, health-care workers attentiveness to acute situations, and hospital accessibility in case of symptoms. A mean score of 8 out of 10 or higher was predefined as perceived high quality
Time Frame
12 month period
Secondary Outcome Measure Information:
Title
Number of rheumatology teleconsultations (email, telephone, video)
Description
Number of rheumatology teleconsultations (email, telephone, video)
Time Frame
12 month period
Title
DAS28
Description
Disease Activity Score
Time Frame
12 month period
Title
PROMs: disease activity score (RAPID3)
Description
PROMs: disease activity score (RAPID3)
Time Frame
12 month period
Title
PROMs: Patient acceptable symptom state (PASS)
Description
PROMs: Patient acceptable symptom state (PASS)
Time Frame
12 month period
Title
PROMs: participation (WPAI)
Description
PROMs: participation (WPAI)
Time Frame
12 month period
Title
PROMs: pain (NRS)
Description
PROMs: pain (NRS)
Time Frame
12 month period
Title
PROMs: fatigue (NRS)
Description
PROMs: fatigue (NRS)
Time Frame
12 month period
Title
PROMs: physical function (HAQ-DI)
Description
PROMs: physical function (HAQ-DI)
Time Frame
12 month period
Title
PROMs: health related quality of life (EQ5D)
Description
PROMs: health related quality of life (EQ5D)
Time Frame
12 month period
Title
PROMs: health related quality of life (SF36)
Description
PROMs: health related quality of life (SF36)
Time Frame
12 month period
Title
Physical performance: 50 meter walking test
Description
Physical performance: 50 meter walking test
Time Frame
12 month period
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
(S)AE's assessed by CTCAE v4.0
Time Frame
12 month period
Title
Cost-effectiveness: healthcare utilization questionnaire
Description
Cost-effectiveness: healthcare utilization questionnaire
Time Frame
12 month period
Title
Patient experience: System usability scale (SUS)
Description
Patient experience: System usability scale (SUS)
Time Frame
12 month period
Title
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Description
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Time Frame
12 month period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all consecutive patients;
signed, written informed consent;
18 -75 years of age;
clinical diagnosis of RA;
≥ 6 months stable low disease activity or remission, according to the treating rheumatologist;
able to read and understand simple Dutch language instructions;
ownership or access to a smartphone, tablet or computer and having internet access;
able to conduct a teleconsultation on a smartphone, tablet or computer.
Exclusion Criteria:
severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirjam Hegeman
Phone
+31534872450
Email
M.Hegeman@MST.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Peter ten Klooster
Phone
+31534899180
Email
p.m.tenklooster@utwente.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Vonkeman, MD
Organizational Affiliation
University of Twente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7512KZ
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirjam Hegeman
Phone
0031534872450
Email
m.hegeman@mst.nl
First Name & Middle Initial & Last Name & Degree
Peter ten Klooster, PhD
Phone
0031534872450
Email
p.m.tenklooster@utwente.nl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
Upon reasonable request to p.m.tenklooster@utwente.nl
Learn more about this trial
Rheum@Home: RA Remote Patient Monitoring
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