Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS).
Primary Purpose
Ankylosing Spondylitis
Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing spondylitis; physiotherapy; Salaso
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Ankylosing Spondylitis
Exclusion Criteria:
- Previous spinal surgery
- Spondylolisthesis
- Unwillingness to participate
- Unable to complete self-report questionnaires
- Progressive neurological deficit
- Neurological disease
- Cauda equina syndrome
- Unable to exercise on medical grounds
Sites / Locations
- Physiotherapy Department, Saint James's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physiotherapy via the Salaso Apllication Intervention
Arm Description
All participants' physiotherapy- prescribed exercise programmes will be monitored via the Salaso application. Telehealth appointments will occur monthly and modifications to exercises will be made as required. This will continue for the 6-month duration of the intervention.
Outcomes
Primary Outcome Measures
Bath Ankylosing Spondylitis Metrology Index
Measure of spinal mobility
Secondary Outcome Measures
Bath Ankylosing Spondylitis Disease Activity Index
Measuring disease activity in AS
Bath Ankylosing Spondylitis Functional Index
Measuring functional activity in AS
Arthritis Self-Efficacy Scale (ASES)
The scale is an assessment of a person's ability to self-manage his/her pain, function and other symptoms. The self-efficacy function scale has 9 questions, each scored on a scale of 1-10, with a total minimum score of 10 and a maximum score of 90. The self-efficacy pain scale has 5 questions, with a total minimum score of 5 and a maximum score of 50. The self-efficacy other symptoms scale has 6 questions, with a minimum total score of 6 and a maximum score of 60. The other symptoms scale and the pain scale may be combined, with a sum score given.
Exercise Benefits/Barriers Scale (EBBS)
Measuring the perceived benefits of and barriers to performing the prescribed exercises. There are 43 questions in total. It may be scored in it's entirety or as two separate scales. Scores can range from 43 to 172. The higher the score, the more positively the individual perceives exercise. The benefits scale is scored between 29 and 116. The barriers scale is scored between 14 and 56. The higher the score on the barriers scale, the greater the perception of barriers to exercise. If combined, the barriers scale is reverse-scored.
Full Information
NCT ID
NCT03457285
First Posted
February 1, 2018
Last Updated
November 6, 2018
Sponsor
St. James's Hospital, Ireland
Collaborators
Salaso Health Solutions Limited, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT03457285
Brief Title
Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS).
Official Title
A Feasibility Study to Investigate the Use of Salaso to Increase Access to Physiotherapy and Increase Compliance to Exercise Prescription and Physical Activity in the Management of Ankylosing Spondylitis (AS).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
April 17, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. James's Hospital, Ireland
Collaborators
Salaso Health Solutions Limited, Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a pilot study to investigate the use of Salaso, a web based exercise app, to increase access to physiotherapy and improve physical activity in patients attending St James's Hospital Rheumatology for Ankylosing Spondylitis (AS). Participants will be set up on the app and given an individual exercise programme. All individual exercises and exercise class videos will be available on the app. Completion of exercises can be logged on the app and exercise compliance will then be monitored remotely by the physiotherapist through the Salaso app. The physiotherapist will have a monthly telehealth session with each participant to assess progress and to address any difficulties. Outcome measures will be completed at initial assessment and again at the end of the pilot study. This data will then be analysed to assess the effectiveness of the Salaso app as a treatment option for AS.
Detailed Description
AS is a chronic inflammatory condition affecting the spine and other joints, causing pain and stiffness. Currently approximately 150 people attend Saint James's Hospital rheumatology department for management of their condition. Physiotherapy plays a key role in this management. As this is often a younger patient population, it can be challenging for them to attend appointments due to work and family commitments. It is envisaged that this pilot will enhance treatment options for all participants.
The aims of this study are: to improve use of exercise and physical activity using an online exercise application; to improve self-management skills in monitoring progress and ability to exercise independently using an online exercise application; to provide an online appointment review option to patients who are unable to attend physiotherapy appointments in St James's Hospital.
Descriptive statistics will be used to record and analyse the study data, using SPSS software.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing spondylitis; physiotherapy; Salaso
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the same intervention
Masking
None (Open Label)
Masking Description
No masking will take place
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy via the Salaso Apllication Intervention
Arm Type
Experimental
Arm Description
All participants' physiotherapy- prescribed exercise programmes will be monitored via the Salaso application. Telehealth appointments will occur monthly and modifications to exercises will be made as required.
This will continue for the 6-month duration of the intervention.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Salaso
Intervention Description
Participants, with a confirmed diagnosis of AS, will be invited to participate. Once participants have provided informed consent, they will be required to complete the outcome measures provided. Participants will be set up to use the online exercise application and educated on its use.
Participants will then have access to videos of suitable exercises or exercise classes to follow and education material on their condition to read. Participants will be able to complete AS specific outcome measures and record their progress. Participants will also have a monthly video call with the senior rheumatology physiotherapist to discuss their exercise programme, symptoms and management. The participants will also record their compliance with their exercise programmes.
After the 6 month pilot period, participants will be required to complete the same outcome measures completed at the start of the study.
Primary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Metrology Index
Description
Measure of spinal mobility
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Disease Activity Index
Description
Measuring disease activity in AS
Time Frame
6 months
Title
Bath Ankylosing Spondylitis Functional Index
Description
Measuring functional activity in AS
Time Frame
6 months
Title
Arthritis Self-Efficacy Scale (ASES)
Description
The scale is an assessment of a person's ability to self-manage his/her pain, function and other symptoms. The self-efficacy function scale has 9 questions, each scored on a scale of 1-10, with a total minimum score of 10 and a maximum score of 90. The self-efficacy pain scale has 5 questions, with a total minimum score of 5 and a maximum score of 50. The self-efficacy other symptoms scale has 6 questions, with a minimum total score of 6 and a maximum score of 60. The other symptoms scale and the pain scale may be combined, with a sum score given.
Time Frame
6 months
Title
Exercise Benefits/Barriers Scale (EBBS)
Description
Measuring the perceived benefits of and barriers to performing the prescribed exercises. There are 43 questions in total. It may be scored in it's entirety or as two separate scales. Scores can range from 43 to 172. The higher the score, the more positively the individual perceives exercise. The benefits scale is scored between 29 and 116. The barriers scale is scored between 14 and 56. The higher the score on the barriers scale, the greater the perception of barriers to exercise. If combined, the barriers scale is reverse-scored.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of Ankylosing Spondylitis
Exclusion Criteria:
Previous spinal surgery
Spondylolisthesis
Unwillingness to participate
Unable to complete self-report questionnaires
Progressive neurological deficit
Neurological disease
Cauda equina syndrome
Unable to exercise on medical grounds
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ciaran Brennan
Phone
0035314162503
Email
cbrennan2@stjames.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Mark McGowan
Phone
0035314162503
Email
mmcgowan@tjames.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finbar O'Shea
Organizational Affiliation
Consultant Rheumatologist, Saint James's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy Department, Saint James's Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ciarán Brennan, MSc, BSc
12. IPD Sharing Statement
Learn more about this trial
Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS).
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