NCT02371915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

December 8, 2014

Last Update Submit

October 25, 2016

Conditions

Keywords

Rural accessTelehealth

Outcome Measures

Primary Outcomes (1)

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

    at 3 month intervals over nine months

Secondary Outcomes (7)

  • Change in European Quality of Life - 5 Dimensions(EQ-5D)

    at 3 month intervals over nine months

  • Change in Epworth Sleepiness Scale

    at 3 month intervals over nine months

  • Change in Healthcare Use

    at 3 month intervals over nine months

  • Change in Modified Health Assessment Questionnaire (MHAQ)

    at 3 month intervals over nine months

  • Change in Work Productivity and Activity Impairment Questionnaire (WPAI)

    at 3 month intervals over nine months

  • +2 more secondary outcomes

Study Arms (2)

Videoconference follow-up

EXPERIMENTAL

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.

Other: Videoconference follow-up

Control

NO INTERVENTION

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

Interventions

Rheumatology visits to take place video videoconference with a physiotherapist present

Videoconference follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Regina Taylor-Gjevre, MD

    Univsersity of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 8, 2014

First Posted

February 26, 2015

Study Start

June 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations