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Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis

Primary Purpose

Inflammatory Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Videoconference follow-up
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inflammatory Arthritis focused on measuring Rural access, Telehealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Part A: Patients with established rheumatologist diagnosed RA attending rheumatology clinic at Royal University Hospital, (Saskatoon) and providing informed consent, will be recruited.

Part B: As the target population for future telehealth/VC utilization will be patients living outside the urban centers, participants will be similarly selected. Inclusion criteria will be: age over 18 years, ability to provide informed consent, place of residence 100 kilometers or more outside of Saskatoon, and rheumatologist established diagnosis of rheumatoid arthritis.

Exclusion Criteria:

Exclusion criteria will include participation in the earlier validation study (Part A).

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Videoconference follow-up

Control

Arm Description

These subjects will remain in or near their home communities for rheumatology follow-up visits. Follow-up visits will occur via telehealth/videoconferencing, with a physiotherapist present, performing the in-person assessment, supported by the rheumatologist via videoconference.

These subjects will continue to travel into Saskatoon for the rheumatology visits, as they normally would for routine follow-up visits with their rheumatologist.

Outcomes

Primary Outcome Measures

Change in Disease Activity Score-28 (DAS-28)

Secondary Outcome Measures

Change in European Quality of Life - 5 Dimensions(EQ-5D)
Change in Epworth Sleepiness Scale
Change in Healthcare Use
Change in Modified Health Assessment Questionnaire (MHAQ)
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Change in International Physical Activity Questionnaire (IPAQ)
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)

Full Information

First Posted
December 8, 2014
Last Updated
October 25, 2016
Sponsor
University of Saskatchewan
Collaborators
Canadian Initiative for Outcomes in Rheumatology Care
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1. Study Identification

Unique Protocol Identification Number
NCT02371915
Brief Title
Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis
Official Title
Addressing Rural and Remote Access Disparities for Patients With Inflammatory Arthritis Through Telehealth/Videoconferencing and Innovative Inter-professional Care Models
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Canadian Initiative for Outcomes in Rheumatology Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project will be conducted in two phases. Phase 1: RA patients will be recruited to participate in five repeated examinations occurring in one day to compare between and within specialties, ensuring reasonable equivalency of examination findings. Phase 2: RA patients living > 100 km from Saskatoon will be randomized to the intervention or control group, with both groups having three follow-up appointments in 3-month intervals. The intervention group will be evaluated by a physiotherapist supported by a rheumatologist through videoconferencing, while the control group will continue to travel to Saskatoon for follow-up care.
Detailed Description
Part A: Validation Study This study involves inter-professional care with rural-based physical therapists and urban-based rheumatologists, it will be a valuable first step to validate comparability of the physical examination. We shall compare physical examination accuracy between and within examiner disciplines. Examiners will include the three rheumatologist study investigators and three participating physical therapists with additional training in inflammatory rheumatic diseases and experienced in musculoskeletal assessment. Procedures: All examiners will undergo a standardized review of examination techniques and documentation prior to participating. Comparison groups will be: Rheumatologist A. to Rheumatologist B. Physiotherapist A. to Physiotherapist B. Rheumatologist A/B to Physiotherapist C/teleconferenced Rheumatologist C. We will use web-based videoconferencing software. This desktop-based solution is currently being piloted by Telehealth Saskatchewan and is used extensively in Ontario. This technology satisfies Health Information Protection Act (HIPA) as well as the Saskatchewan privacy and security concerns. An examining room with telehealth/videoconference equipment will be available for patient distance examination for comparison group C as listed above. The rheumatologist will be in a physically separate room with viewing equipment in a mock distance evaluation. The proposed study will be conducted in cooperation with the Canadian Centre for Health and Safety in Agriculture (CCHSA) within the ≈1350 m2 National Agricultural-Industrial Hygiene Laboratory. Clinical visits will be conducted at the CCHSA. Part B: Randomized Controlled Rheumatoid Arthritis Care Delivery Model Trial Randomization: Participating patients will be randomly allocated to two arms, either to be followed by telehealth/videoconferencing in or near their home community or to continue traveling to their Saskatoon rheumatology clinic. Intervention: One study arm will be followed in traditional rheumatology clinic (in-person examining rheumatologist). The second study arm will be followed by telehealth/videoconferencing. Patients in the telehealth/videoconferencing arm will be examined by a rural-based physical therapist who will report exam findings during telehealth review with the urban-based rheumatologist. Follow-up visits will be every three months in both arms. All patients will complete standardized history/data-collection forms. Patients will be followed in their respective study arms for nine months, and then will be evaluated in-person in rheumatology clinic for final face-to-face disease activity evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Arthritis
Keywords
Rural access, Telehealth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Videoconference follow-up
Arm Type
Experimental
Arm Description
These subjects will remain in or near their home communities for rheumatology follow-up visits. Follow-up visits will occur via telehealth/videoconferencing, with a physiotherapist present, performing the in-person assessment, supported by the rheumatologist via videoconference.
Arm Title
Control
Arm Type
No Intervention
Arm Description
These subjects will continue to travel into Saskatoon for the rheumatology visits, as they normally would for routine follow-up visits with their rheumatologist.
Intervention Type
Other
Intervention Name(s)
Videoconference follow-up
Intervention Description
Rheumatology visits to take place video videoconference with a physiotherapist present
Primary Outcome Measure Information:
Title
Change in Disease Activity Score-28 (DAS-28)
Time Frame
at 3 month intervals over nine months
Secondary Outcome Measure Information:
Title
Change in European Quality of Life - 5 Dimensions(EQ-5D)
Time Frame
at 3 month intervals over nine months
Title
Change in Epworth Sleepiness Scale
Time Frame
at 3 month intervals over nine months
Title
Change in Healthcare Use
Time Frame
at 3 month intervals over nine months
Title
Change in Modified Health Assessment Questionnaire (MHAQ)
Time Frame
at 3 month intervals over nine months
Title
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame
at 3 month intervals over nine months
Title
Change in International Physical Activity Questionnaire (IPAQ)
Time Frame
at 3 month intervals over nine months
Title
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Time Frame
at 3 month intervals over nine months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Part A: Patients with established rheumatologist diagnosed RA attending rheumatology clinic at Royal University Hospital, (Saskatoon) and providing informed consent, will be recruited. Part B: As the target population for future telehealth/VC utilization will be patients living outside the urban centers, participants will be similarly selected. Inclusion criteria will be: age over 18 years, ability to provide informed consent, place of residence 100 kilometers or more outside of Saskatoon, and rheumatologist established diagnosis of rheumatoid arthritis. Exclusion Criteria: Exclusion criteria will include participation in the earlier validation study (Part A).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regina Taylor-Gjevre, MD
Organizational Affiliation
Univsersity of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis

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