Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NP face to face management of Chronic Low Back Pain
PT face to face management of Chronic Low Back Pain
Interprofessional Videoconferencing for Chronic Low Back Pain
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, telehealth, videoconferencing, access to physical therapy, interprofessional care, rural health
Eligibility Criteria
Inclusion Criteria:
- adult 18-80
- low back pain and/or related leg pain affecting function, >3 months duration
Exclusion Criteria:
- clients within a third party payer insurance coverage system
- clients with primarily neck or thoracic pain
- clients with language or comprehension difficulties that would limit completion of paperwork
Sites / Locations
- University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Usual Care (NP)
PT in-person
PT/NP Telehealth
Arm Description
Rural NP with client in-person, usual care
Urban PT travels to rural area to manage patient's back pain in-person.
Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient
Outcomes
Primary Outcome Measures
Short term impact of patient/provider satisfaction
questionnaire
Short term outcome of patient experience with Telehealth
qualitative questionnaire
Medium term outcome of patient and provider satisfaction
questionnaire
Short term impact of patient function
Modified Oswestry Disability questionnaire
Short term impact on pain
Numeric Pain Rating Scale - questionnaire
Short term impact on quality of life
Euro-Qol health survey instrument (EQ-5D)
Medium term impact on pain
Numeric Pain Rating Scale - questionnaire
Medium term impact on quality of life
Euro-Qol health survey instrument (EQ-5D)
Medium impact on patient function
Modified Oswestry Disability Index questionnaire
Secondary Outcome Measures
Cost effectiveness of each of 3 arms of study
patient diaries
Long term outcome on patient/provider satisfaction
questionnaire
Long term impact on quality of life
Euro-Qol health survey instrument (EQ-5D)
Long term impact on function
Modified Oswestry Disability Index questionnaire
Long term impact on pain
Numeric Pain Rating Scale
Full Information
NCT ID
NCT02225535
First Posted
July 31, 2014
Last Updated
October 10, 2018
Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation, Ralston Brothers Grant (Kelsey Trail Health Region)
1. Study Identification
Unique Protocol Identification Number
NCT02225535
Brief Title
Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth
Official Title
Advancing Interprofessional Primary Health Care Services in Rural Settings for People With Chronic Low Back Disorders: Investigation of a Physiotherapist and Nurse Practitioner Intervention Delivered Through Telehealth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation, Ralston Brothers Grant (Kelsey Trail Health Region)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to compare "usual care" for chronic low back disorders in a rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy (PT) into a rural health care team:
in-person PT assessment, where the PT travels from an urban center
interprofessional Telehealth assessment where the local NP is joined by a PT via Telehealth.
The project will evaluate health, systems and process outcomes, comparative effectiveness and costs of the three methods of assessment. The hypothesis is that an interprofessional Telehealth assessment with be as effective as an in-person PT assessment, but more effective than usual care.
Detailed Description
The study design will include two intervention groups and a control group with 20 participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person PT and, 3. "usual-care" provided by a NP. Due to the interprofessional nature of the intervention, the NP involved in the telehealth-based intervention group may alter their "usual care" practice; therefore, the control group participants will be drawn from the practices of 2 NPs not involved in the Telehealth intervention providing services out of a different clinic. Each PT and the NP alone will complete a standardized online diagnostic classification tool.Participants will be randomly assigned to one of the three groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, telehealth, videoconferencing, access to physical therapy, interprofessional care, rural health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care (NP)
Arm Type
Placebo Comparator
Arm Description
Rural NP with client in-person, usual care
Arm Title
PT in-person
Arm Type
Active Comparator
Arm Description
Urban PT travels to rural area to manage patient's back pain in-person.
Arm Title
PT/NP Telehealth
Arm Type
Active Comparator
Arm Description
Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient
Intervention Type
Other
Intervention Name(s)
NP face to face management of Chronic Low Back Pain
Intervention Description
usual NP management of chronic low back disorder
Intervention Type
Other
Intervention Name(s)
PT face to face management of Chronic Low Back Pain
Intervention Description
Includes manual therapy, education, exercise
Intervention Type
Other
Intervention Name(s)
Interprofessional Videoconferencing for Chronic Low Back Pain
Intervention Description
Includes manual therapy, education, exercise.
Primary Outcome Measure Information:
Title
Short term impact of patient/provider satisfaction
Description
questionnaire
Time Frame
up to 2 weeks after assessment
Title
Short term outcome of patient experience with Telehealth
Description
qualitative questionnaire
Time Frame
up to 2 weeks
Title
Medium term outcome of patient and provider satisfaction
Description
questionnaire
Time Frame
3 months
Title
Short term impact of patient function
Description
Modified Oswestry Disability questionnaire
Time Frame
up to 2 weeks after assessment
Title
Short term impact on pain
Description
Numeric Pain Rating Scale - questionnaire
Time Frame
up to 2 weeks after assessment
Title
Short term impact on quality of life
Description
Euro-Qol health survey instrument (EQ-5D)
Time Frame
up to 2 weeks after assessment
Title
Medium term impact on pain
Description
Numeric Pain Rating Scale - questionnaire
Time Frame
3 months
Title
Medium term impact on quality of life
Description
Euro-Qol health survey instrument (EQ-5D)
Time Frame
3 months
Title
Medium impact on patient function
Description
Modified Oswestry Disability Index questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cost effectiveness of each of 3 arms of study
Description
patient diaries
Time Frame
6 months
Title
Long term outcome on patient/provider satisfaction
Description
questionnaire
Time Frame
6 months
Title
Long term impact on quality of life
Description
Euro-Qol health survey instrument (EQ-5D)
Time Frame
6 months
Title
Long term impact on function
Description
Modified Oswestry Disability Index questionnaire
Time Frame
6 months
Title
Long term impact on pain
Description
Numeric Pain Rating Scale
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Barriers and facilitators to use of Telehealth
Description
questionnaire
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult 18-80
low back pain and/or related leg pain affecting function, >3 months duration
Exclusion Criteria:
clients within a third party payer insurance coverage system
clients with primarily neck or thoracic pain
clients with language or comprehension difficulties that would limit completion of paperwork
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenna Bath, PhD
Organizational Affiliation
School of Physical Therapy, University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7J4W3
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27829573
Citation
Bath B, Lovo Grona S, Milosavljevic S, Sari N, Imeah B, O'Connell ME. Advancing Interprofessional Primary Health Care Services in Rural Settings for People with Chronic Low Back Disorders: Protocol of a Community-Based Randomized Controlled Trial. JMIR Res Protoc. 2016 Nov 9;5(4):e212. doi: 10.2196/resprot.5914.
Results Reference
derived
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Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth
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